Infections, Bacterial
Conditions
Keywords
Gepotidacin, Drug Interaction, Pharmacokinetic, Safety, Bacterial Infection, Japanese Healthy Adults
Brief summary
This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.
Interventions
DRUGGepotidacin
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
DRUGCimetidine
Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.
DRUGRifampicin
Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.
DRUGMidazolam
Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.
DRUGDigoxin
Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.
OTHERPlacebo matching to gepotidacin
Placebo matching to gepotidacin tablets will be administered orally.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Cohort 1 to 3 are open-label cohorts. Cohort 4 is a double-blind cohort which contains blinded treatment of gepotidacin and placebo.
Intervention model description
Cohort 1 and 2 are open-label, fixed sequence DDI cohorts. Cohort 3 is an open-label, 2-sequence, 2-period crossover randomized DDI cohort. Cohort 4 is a double-blind, placebo-controlled, randomized sequence study to investigate the safety and PK of gepotidacin.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be greater than or equal to (\>=) 18 to less than or equal to (=\<) 50 years of age inclusive, at the time of signing the informed consent. * Participants who are healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG results. A participant with clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Additional inclusion criteria for Japanese participants (Cohort 4): The participant is a non-naturalized Japanese citizen and holds a Japanese passport (current or expired). The participant has/had 2 Japanese parents and 4 Japanese grandparents who are/were all non-naturalized Japanese citizens, as confirmed by interview. The participant has been living outside of Japan for up to 10 years as confirmed by interview. * Participants have a body weight \>=40 kilograms (kg) and body mass index within the range 18.5 to 32.0 kilograms per square meter (kg/m\^2) (inclusive). * Male and/or female: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 1. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is a woman of non-childbearing potential or Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1 percent (%), for at least 30 days prior to dosing until completion of the follow-up Visit. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention and for women not on effective contraception at least 14 days prior to baseline visit. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Exclusion criteria
* Clinically significant abnormality in the past medical history or at the screening physical examination that in the investigator's opinion may place the participant at risk or interfere with the outcome variables of the study. This includes, but is not limited to, history or current cardiac, hepatic, renal, neurologic, gastro-intestinal (GI), respiratory, hematologic, or immunologic disease. * Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention, or any other condition that may place the participant at risk, in the opinion of the investigator. * Female participant has a positive pregnancy test result or is lactating at Screening or upon admission to the clinic. * Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Note: Testing will be performed according to site procedures. * Within 2 months before Screening, either a confirmed history of Clostridium difficile (C. difficile) diarrhea infection or a past positive of C. difficile toxin test. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * History of drug and/or alcohol abuse within 6 months before Screening, as determined by the investigator, or has a positive drug screen at Screening or upon admission to the clinic. * History of sensitivity/hypersensitivity to any of the study drugs, components thereof, or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor contraindicates their participation. * Cohort 2 Only: Participant is a contact lens wearer who is unable or unwilling to wear glasses for the duration of the study and for 5 half-lives after the last dose of rifampicin. * Use of any systemic antibiotic within 30 days of screening. * Participants must abstain from taking prescription or non-prescription drugs (except for hormonal contraceptives and/or acetaminophen at doses of \<=2 grams/day), vitamins, and dietary or herbal supplements, within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to study intervention until completion of the follow-up Visit, unless, in the opinion of the investigator and Sponsor, the medication will not interfere with the study. Any exceptions will be discussed with the Sponsor or Medical Monitor on a case-by-case basis and the reasons will be documented. * Previous exposure to gepotidacin. * Participant has participated in a clinical trial and has received an investigational product (IP) prior to gepotidacin administration within 30 days, 5 half-lives, or twice the duration of the biological effect of IP (whichever is longer). * Past participation in this clinical study. * Baseline corrected QT interval using the Fridericia formula (QTcF) of \>450 milliseconds (msec) at Screening or Check-in. * Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention. * Alanine aminotransferase (ALT) \>1.5 times upper limit of normal (ULN) at Screening or Check-in. * Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) at Screening or Check-in. * History of any kidney disease or current or chronic history of mild impaired renal function as indicated by an estimated creatinine clearance \<=90 milliliters per minute (mL/min). * A positive test for human immunodeficiency virus (HIV) antibody. * History of regular alcohol consumption within 6 months of Screening defined as an average weekly intake of \>21 units (or an average daily intake of \>3 units) for males or an average weekly intake of \>14 units (or an average daily intake \>2 units) for females. One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer, 30 mL of spirits, or 100 mL of wine. * Cohort 3 Only: Digoxin-related exclusions include the following at Screening: Serum potassium \>5.5 milliequivalent per liter (mEq/L) or \< 3.6 mEq/L Serum magnesium \<1.6 milligrams per deciliter (mg/dL) Serum calcium (total) \<8.5 mg/dL History of hypersensitivity to digoxin or other digitalis glycosides Any clinically relevant abnormality on 12-lead ECG at Screening or Check-in. * Participant has donated blood in excess of 500 mL within 12 weeks prior to dosing or participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period. * Participant is unable to comply with all study procedures, in the opinion of the investigator. * Participant should not participate in the study, in the opinion of the investigator or Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric least square (LS) mean and 90 percent (%) confidence interval (CI) of the geometric LS means have been presented. |
| Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 2: Cmax of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 2: Tmax of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 2: AUC(0-t) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Cmax of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Tlag of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. |
| Cohort 3: Tmax of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC(0-t) of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: AUC(0-infinity) of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Cmax of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Tlag of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. |
| Cohort 3: Tmax of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC(0-t) of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: AUC(0-infinity) of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 24 Hours Post-dose (AUC[0-24]) of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 48 Hours Post-dose (AUC[0-48]) of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC From Time 0 (Predose) to Time Tau (AUC[0-tau]) of Gepotidacin in Plasma After the First Dose of 3000 Mg-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Evening Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Accumulation Ratio Based on Cmax (RoCmax) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose. |
| Cohort 4: Accumulation Ratio Based on AUC(0-tau) (RoAUC) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose. |
| Cohort 4: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Up to 22 days | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment. |
| Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 22 days | Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose laboratory (lab) value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 (%). High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 22 days | Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, Blood Urea Nitrogen (BUN). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 22 days | Urine samples were collected at indicated time points for the analysis of urinalysis parameters including potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 22 days | Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | Up to 22 days | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the Bazett formula (QTcB) Interval and corrected QT interval using the Fridericia formula (QTcF) Interval has been reported. |
| Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 4: Tlag of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 3: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-48) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose+ Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Minimum Observed Concentration (Cmin) of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: T1/2 of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Vz/F of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: CL/F of Digoxin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Cmin of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: T1/2 of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Vz/F of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: CL/F of Midazolam in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 3: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose ) | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Cohort 3: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC (0-48) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Percentage of the Given Dose of Drug Excreted in Urine (fe%) Following Two 3000 mg Doses of Gepotidacin (First Dose + Second Dose ) | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %. |
| Cohort 3: CLr of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Number of Participants With SAE and Non-SAE | Up to 30 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment. |
| Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 30 days | Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 30 days | Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) for Gepotidacin 1500 mg Under Fed Condition | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100%. |
| Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 30 days | Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 30 days | Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | Up to 30 days | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported. |
| Cohort 4: T1/2 of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Vz/F of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: CL/F of Gepotidacin Following Single Dose of 1500 mg in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose )-Fed State | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Ae Total of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Cohort 4: AUC(0-24) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: CLr of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Cohort 4: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours post-dose in Treatment Period 3 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-48) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours post-dose in Treatment Period 3 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin Following Two 3000 mg Doses-Fed State | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %. |
| Cohort 4: CLr of Gepotidacin Following Two 3000 mg Dose-Fed State | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 4: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 1: AUC (0-24) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 1: AUC(0-48) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 1: Tlag of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 1: Apparent Volume of Distribution (Vz/F) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 1: Apparent Oral Clearance (CL/F) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 1: Total Unchanged Drug (Ae Total) of Gepotidacin in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 1: AUC(0-24) of Gepotidacin in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours Post-dose in each Treatment periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 1: AUC(0-48) of Gepotidacin in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 1: Renal Clearance (CLr) of Gepotidacin | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented. |
| Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Cohort 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 percent (%). |
| Cohort 1: Number of Participants With SAE and Non-SAE | Up to 17 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment. |
| Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 17 days | Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 %. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 2: CLr of Gepotidacin | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 17 days | Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 17 days | Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 17 days | Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | Up to 17 days | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported. |
| Cohort 2: AUC(0-24) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 2: AUC(0-48) of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 2: T1/2 of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 2: Vz/F of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 2: CL/F of Gepotidacin in Plasma | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 2: Ae Total of Gepotidacin in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 2: AUC(0-24) of Gepotidacin in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 2: AUC(0-48) of Gepotidacin in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented. |
| Cohort 2: Ae(t1-t2) of Gepotidacin | 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Cohort 2: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %. |
| Cohort 2: Number of Participants With SAE and Non-SAE | Up to 26 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment. |
| Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 26 days | Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 26 days | Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 26 days | Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Up to 26 days | Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment. |
| Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | Up to 26 days | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported. |
| Cohort 3: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC(0-tau) of Gepotidacin in Plasma First Dose of 3000 mg (First Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: RoCmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose. |
| Cohort 3: RoAUC of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose. |
| Cohort 3: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
| Cohort 3: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2 | Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cohort 4: AUC(0-tau) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2 | Urine samples were collected at indicated time points. AUC(0-tau) can be calculated only for multiple doses and not for single dose as tau refers to the dosing interval. Hence, AUC(0-tau) could not be calculated for Gepotidacin 1500 mg single dose as mentioned in Reporting and Analysis Plan. The results for this outcome measure will never be posted. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at a single center in the United States and designed to assess co-administration of probe substrates with gepotidacin in study Cohorts 1 to 3 and establishing pharmacokinetics and safety in a Japanese cohort in Cohort 4.
Pre-assignment details
A total of 64 participants (14 in Cohort 1, 17 in Cohort 2, 19 in Cohort 3 and 14 participants in Cohort 4) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg Participants received a single oral dose of gepotidacin 1500 milligrams (mg) on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants were administered with cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2. Participants had a follow-up of 7 days after the last dose of cimetidine. | 14 |
| Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) along with a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2. Participants had a follow-up of 10 days after the last dose of rifampicin. | 17 |
| Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2. | 10 |
| Cohort 3: Gepotidacin 3000 mg + Digoxin + Midazolam/Digoxin+Midazolam Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2. | 9 |
| Cohort 4:Gepotidacin 1500 mg Fed/Gepotidacin 1500 mg Fasted/Gepotidacin 3000 mg Fed Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 followed by a washout of 3 days . In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin. | 6 |
| Cohort 4:Gepotidacin 1500 mg Fasted/Gepotidacin 1500 mg Fed/Gepotidacin 3000 mg Fed Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin. | 5 |
| Cohort 4: Placebo Fed/ Placebo Fasted/ Placebo Fed Japanese participants received a single dose of placebo matching gepotidacin under fed conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of placebo matching gepotidacin under fasted conditions on Day 1 of Period 2, followed by a washout of 3 days. In Period 3, participants were administered with two doses of placebo matching gepotidacin (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days. | 3 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Cohort1:Treatment Period 1(Up to 3 Days) | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cohort2:Treatment Period2(Up to 10 Days) | Physician Decision | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Cohort2:Treatment Period2(Up to 10 Days) | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Cohort3:Treatment Period 1(Up to 5 Days) | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg | Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin | Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam | Cohort 3: Gepotidacin 3000 mg + Digoxin + Midazolam/Digoxin+Midazolam | Cohort 4:Gepotidacin 1500 mg Fed/Gepotidacin 1500 mg Fasted/Gepotidacin 3000 mg Fed | Cohort 4:Gepotidacin 1500 mg Fasted/Gepotidacin 1500 mg Fed/Gepotidacin 3000 mg Fed | Cohort 4: Placebo Fed/ Placebo Fasted/ Placebo Fed | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-64 years | 14 Participants | 17 Participants | 10 Participants | 9 Participants | 6 Participants | 5 Participants | 3 Participants | 64 Participants |
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE/WHITE | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized ASIAN(A)/BLACK OR AFRICAN AMERICAN | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 8 Participants | 7 Participants | 6 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 26 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN/WHITE | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized JAPANESE HERITAGE(H)/EAST A H/SOUTH EAST A H | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 6 Participants | 5 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized WHITE | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 2 Participants | 25 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 7 Participants | 4 Participants | 4 Participants | 3 Participants | 1 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 | 0 / 17 | 0 / 17 | 0 / 14 | 0 / 19 | 0 / 18 | 0 / 3 | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 14 | 0 / 13 | 3 / 17 | 2 / 17 | 2 / 14 | 1 / 19 | 11 / 18 | 0 / 3 | 1 / 11 | 2 / 11 | 4 / 11 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 17 | 0 / 17 | 0 / 14 | 0 / 19 | 0 / 18 | 0 / 3 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma | 20.3 Hours*micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma | 23.4 Hours*micrograms per milliliter |
90% CI: [1.059, 1.265]
Primary
Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma | 20.6 Hours* micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma | 23.9 Hours* micrograms per milliliter |
90% CI: [1.062, 1.264]
Primary
Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric least square (LS) mean and 90 percent (%) confidence interval (CI) of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population comprised of all participants in the Pharmacokinetic Population (received at least 1 dose of study intervention and had at least 1 non-missing plasma or urine pharmacokinetic concentration) who received study intervention for whom valid and evaluable plasma or urine pharmacokinetic parameters were derived.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma | 4.817 Micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma | 4.548 Micrograms per milliliter |
90% CI: [0.753, 1.184]
Primary
Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma | 11.344 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma | 12.415 Hours |
90% CI: [0.959, 1.249]
Primary
Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma | 2.500 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma | 2.500 Hours |
90% CI: [-0.75, 0.742]
Primary
Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma | 19.3 Hours*micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma | 9.3 Hours*micrograms per milliliter |
90% CI: [0.435, 0.526]
Primary
Cohort 2: AUC(0-t) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: AUC(0-t) of Gepotidacin in Plasma | 19.0 Hours*micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: AUC(0-t) of Gepotidacin in Plasma | 9.0 Hours*micrograms per milliliter |
90% CI: [0.433, 0.525]
Primary
Cohort 2: Cmax of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Cmax of Gepotidacin in Plasma | 3.735 Micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Cmax of Gepotidacin in Plasma | 2.728 Micrograms per milliliter |
90% CI: [0.635, 0.84]
Primary
Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma | 0.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma | 0.000 Hours |
90% CI: [0, 0]
Primary
Cohort 2: Tmax of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Tmax of Gepotidacin in Plasma | 2.500 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Tmax of Gepotidacin in Plasma | 2.000 Hours |
90% CI: [-1, 0.492]
Primary
Cohort 3: AUC(0-infinity) of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-infinity) of Digoxin in Plasma | 30743.6 Hours*picograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: AUC(0-infinity) of Digoxin in Plasma | 34456.5 Hours*picograms per milliliter |
90% CI: [0.983, 1.278]
Primary
Cohort 3: AUC(0-infinity) of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-infinity) of Midazolam in Plasma | 24.9 Hours*nanograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: AUC(0-infinity) of Midazolam in Plasma | 47.4 Hours*nanograms per milliliter |
90% CI: [1.619, 2.234]
Primary
Cohort 3: AUC(0-t) of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-t) of Digoxin in Plasma | 25353.1 Hours*picograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: AUC(0-t) of Digoxin in Plasma | 30842.3 Hours*picograms per milliliter |
90% CI: [1.085, 1.363]
Primary
Cohort 3: AUC(0-t) of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-t) of Midazolam in Plasma | 23.3 Hours*nanograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: AUC(0-t) of Midazolam in Plasma | 44.8 Hours*nanograms per milliliter |
90% CI: [1.622, 2.278]
Primary
Cohort 3: Cmax of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Cmax of Digoxin in Plasma | 1553.135 Picograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Cmax of Digoxin in Plasma | 2381.259 Picograms per milliliter |
90% CI: [1.274, 1.845]
Primary
Cohort 3: Cmax of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Cmax of Midazolam in Plasma | 5.238 Nanograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Cmax of Midazolam in Plasma | 6.507 Nanograms per milliliter |
90% CI: [1.046, 1.475]
Primary
Cohort 3: Tlag of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Tlag of Digoxin in Plasma | 0.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Tlag of Digoxin in Plasma | 0.000 Hours |
90% CI: [0, 0]
Primary
Cohort 3: Tlag of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Tlag of Midazolam in Plasma | 0.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Tlag of Midazolam in Plasma | 0.000 Hours |
90% CI: [0, 0]
Primary
Cohort 3: Tmax of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Tmax of Digoxin in Plasma | 2.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Tmax of Digoxin in Plasma | 1.275 Hours |
90% CI: [-1, -0.233]
Primary
Cohort 3: Tmax of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Tmax of Midazolam in Plasma | 0.650 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Tmax of Midazolam in Plasma | 0.500 Hours |
90% CI: [-0.25, 0.8]
Primary
Cohort 4: Accumulation Ratio Based on AUC(0-tau) (RoAUC) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Accumulation Ratio Based on AUC(0-tau) (RoAUC) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | 1.254 Ratio | Geometric Coefficient of Variation 13.1 |
Primary
Cohort 4: Accumulation Ratio Based on Cmax (RoCmax) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Accumulation Ratio Based on Cmax (RoCmax) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | 1.103 Ratio | Geometric Coefficient of Variation 39.3 |
Primary
Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 24 Hours Post-dose (AUC[0-24]) of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 24 Hours Post-dose (AUC[0-24]) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 20.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 16.8 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 24 Hours Post-dose (AUC[0-24]) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 19.0 Hours*micrograms per milliliter | Geometric Coefficient of Variation 12.9 |
Primary
Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 48 Hours Post-dose (AUC[0-48]) of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 48 Hours Post-dose (AUC[0-48]) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 21.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 16 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 48 Hours Post-dose (AUC[0-48]) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 20.0 Hours*micrograms per milliliter | Geometric Coefficient of Variation 13.2 |
Primary
Cohort 4: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | 84.6 Hours*micrograms per milliliter | Geometric Coefficient of Variation 23.1 |
Primary
Cohort 4: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | 90.8 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22.9 |
Primary
Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 22.3 Hours*micrograms per milliliter | Geometric Coefficient of Variation 15.5 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 20.4 Hours*micrograms per milliliter | Geometric Coefficient of Variation 13.3 |
Primary
Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 22.3 Hours*Micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 20.4 Hours*Micrograms per milliliter |
90% CI: [0.991, 1.209]
Primary
Cohort 4: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Evening Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Evening Dose)-Fed State | 46.7 Hours*micrograms per milliliter | Geometric Coefficient of Variation 23.1 |
Primary
Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 21.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 16 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma | 20.0 Hours*micrograms per milliliter | Geometric Coefficient of Variation 13.2 |
Primary
Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 21.9 Hours*Micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 20.0 Hours*Micrograms per milliliter |
90% CI: [0.987, 1.212]
Primary
Cohort 4: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | 91.4 Hours*micrograms per milliliter | Geometric Coefficient of Variation 23 |
Primary
Cohort 4: AUC From Time 0 (Predose) to Time Tau (AUC[0-tau]) of Gepotidacin in Plasma After the First Dose of 3000 Mg-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC From Time 0 (Predose) to Time Tau (AUC[0-tau]) of Gepotidacin in Plasma After the First Dose of 3000 Mg-Fed State | 37.3 Hours*micrograms per milliliter | Geometric Coefficient of Variation 25.4 |
Primary
Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma | 5.436 Micrograms per milliliter | Geometric Coefficient of Variation 27.8 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma | 5.143 Micrograms per milliliter | Geometric Coefficient of Variation 34.2 |
Primary
Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 5.421 Micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 5.158 Micrograms per milliliter |
90% CI: [0.824, 1.34]
Primary
Cohort 4: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State | 11.204 Micrograms per milliliter | Geometric Coefficient of Variation 45 |
Primary
Cohort 4: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | 12.363 Micrograms per milliliter | Geometric Coefficient of Variation 21.3 |
Primary
Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the Bazett formula (QTcB) Interval and corrected QT interval using the Fridericia formula (QTcF) Interval has been reported.
Time frame: Up to 22 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcB Interval | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcF Interval | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcF Interval | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcB Interval | 8 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcB Interval | 3 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcF Interval | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcB Interval | 9 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval | QTcF Interval | 2 Participants |
Primary
Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.
Time frame: Up to 22 days
Population: Safety Population comprised of all participants who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any non-SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any non-SAE | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any SAE | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any SAE | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any non-SAE | 2 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any SAE | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) | Any non-SAE | 4 Participants |
Primary
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, Blood Urea Nitrogen (BUN). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 22 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine;To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine;To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 1 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine;To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 9 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine;To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 1 Participants |
Primary
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose laboratory (lab) value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 (%). High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 22 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 1 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 1 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 1 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 9 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 2 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 2 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 9 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 10 Participants |
Primary
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 22 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 9 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 1 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 2 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 9 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 1 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 11 Participants |
Primary
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 22 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 1 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 10 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 1 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 11 Participants |
| Cohort 4: Gepotidacin 3000 mg Fed | Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
Primary
Cohort 4: Tlag of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Tlag of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 0.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Tlag of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 0.000 Hours |
90% CI: [0, 0.25]
Primary
Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma | 2.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma | 1.500 Hours |
Primary
Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 2.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants | 1.500 Hours |
90% CI: [-0.5, 1.25]
Primary
Cohort 4: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State | 2.000 Hours |
Primary
Cohort 4: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State | 2.000 Hours |
Secondary
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (0-2), n=14, 13 | 28.66 Milligrams | Geometric Coefficient of Variation 185.9 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (2-4), n=14, 12 | 89.18 Milligrams | Geometric Coefficient of Variation 120.8 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (4-6), n=14, 13 | 50.52 Milligrams | Geometric Coefficient of Variation 119.1 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (6-8); n=14, 13 | 34.38 Milligrams | Geometric Coefficient of Variation 56.2 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (8-12), n=12, 13 | 29.90 Milligrams | Geometric Coefficient of Variation 38.3 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (12-24), n=14, 13 | 25.44 Milligrams | Geometric Coefficient of Variation 38.1 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (24-36), n=14, 13 | 10.88 Milligrams | Geometric Coefficient of Variation 43.1 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (36-48), n=14, 13 | 4.50 Milligrams | Geometric Coefficient of Variation 39.3 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (36-48), n=14, 13 | 4.08 Milligrams | Geometric Coefficient of Variation 88.5 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (0-2), n=14, 13 | NA Milligrams | — |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (8-12), n=12, 13 | 30.97 Milligrams | Geometric Coefficient of Variation 38 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (2-4), n=14, 12 | 142.99 Milligrams | Geometric Coefficient of Variation 42.7 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (24-36), n=14, 13 | 8.76 Milligrams | Geometric Coefficient of Variation 89.6 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (4-6), n=14, 13 | 82.77 Milligrams | Geometric Coefficient of Variation 44 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (12-24), n=14, 13 | 22.04 Milligrams | Geometric Coefficient of Variation 121.3 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Ae (6-8); n=14, 13 | 46.22 Milligrams | Geometric Coefficient of Variation 55.3 |
Secondary
Cohort 1: Apparent Oral Clearance (CL/F) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Apparent Oral Clearance (CL/F) of Gepotidacin in Plasma | 72.72 Liters per Hour | Geometric Coefficient of Variation 31.2 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Apparent Oral Clearance (CL/F) of Gepotidacin in Plasma | 64.14 Liters per Hour | Geometric Coefficient of Variation 28 |
Secondary
Cohort 1: Apparent Volume of Distribution (Vz/F) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Apparent Volume of Distribution (Vz/F) of Gepotidacin in Plasma | 1190.16 Liters | Geometric Coefficient of Variation 34 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Apparent Volume of Distribution (Vz/F) of Gepotidacin in Plasma | 1143.29 Liters | Geometric Coefficient of Variation 30.6 |
Secondary
Cohort 1: AUC (0-24) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: AUC (0-24) of Gepotidacin in Plasma | 19.3 Hours*micrograms per milliliter | Geometric Coefficient of Variation 32.6 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: AUC (0-24) of Gepotidacin in Plasma | 21.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 29.7 |
Secondary
Cohort 1: AUC(0-24) of Gepotidacin in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours Post-dose in each Treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: AUC(0-24) of Gepotidacin in Urine | 3292.1 Hours*micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: AUC(0-24) of Gepotidacin in Urine | 3612.4 Hours*micrograms per milliliter |
90% CI: [0.948, 1.27]
Secondary
Cohort 1: AUC(0-48) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: AUC(0-48) of Gepotidacin in Plasma | 20.3 Hours*micrograms per milliliter | Geometric Coefficient of Variation 31.4 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: AUC(0-48) of Gepotidacin in Plasma | 23.0 Hours*micrograms per milliliter | Geometric Coefficient of Variation 28.4 |
Secondary
Cohort 1: AUC(0-48) of Gepotidacin in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: AUC(0-48) of Gepotidacin in Urine | 3578.2 Hours*micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: AUC(0-48) of Gepotidacin in Urine | 3831.1 Hours*micrograms per milliliter |
90% CI: [0.939, 1.221]
Secondary
Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported.
Time frame: Up to 17 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcB Interval | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcF Interval | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcB Interval | 4 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcF Interval | 1 Participants |
Secondary
Cohort 1: Number of Participants With SAE and Non-SAE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.
Time frame: Up to 17 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With SAE and Non-SAE | Any SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With SAE and Non-SAE | Any non-SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With SAE and Non-SAE | Any SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With SAE and Non-SAE | Any non-SAE | 0 Participants |
Secondary
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 17 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To High | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 13 Participants |
Secondary
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 %. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 17 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 13 Participants |
Secondary
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 17 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 12 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 11 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
Secondary
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 17 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 13 Participants |
Secondary
Cohort 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 percent (%).
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | 22.72 Percent dose excreted | Geometric Coefficient of Variation 53.2 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | 26.90 Percent dose excreted | Geometric Coefficient of Variation 21.3 |
Secondary
Cohort 1: Renal Clearance (CLr) of Gepotidacin
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Renal Clearance (CLr) of Gepotidacin | 16.06 Liters per Hour |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Renal Clearance (CLr) of Gepotidacin | 17.59 Liters per Hour |
90% CI: [0.93, 1.292]
Secondary
Cohort 1: Tlag of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Tlag of Gepotidacin in Plasma | 0.000 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Tlag of Gepotidacin in Plasma | 0.000 Hours |
90% CI: [-0.25, 0]
Secondary
Cohort 1: Total Unchanged Drug (Ae Total) of Gepotidacin in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 1: Total Unchanged Drug (Ae Total) of Gepotidacin in Urine | 337.92 Milligrams |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 1: Total Unchanged Drug (Ae Total) of Gepotidacin in Urine | 410.10 Milligrams |
90% CI: [1, 1.473]
Secondary
Cohort 2: Ae(t1-t2) of Gepotidacin
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (0-2) | 12.67 Milligrams | Geometric Coefficient of Variation 567.5 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (2-4) | 79.84 Milligrams | Geometric Coefficient of Variation 65.6 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (4-6) | 67.48 Milligrams | Geometric Coefficient of Variation 44.3 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (6-8) | 33.92 Milligrams | Geometric Coefficient of Variation 50.5 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (8-12) | 27.59 Milligrams | Geometric Coefficient of Variation 63.1 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (12-24) | 21.17 Milligrams | Geometric Coefficient of Variation 79.2 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (24-36) | 11.04 Milligrams | Geometric Coefficient of Variation 77.9 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (36-48) | 3.61 Milligrams | Geometric Coefficient of Variation 90.3 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (36-48) | 2.75 Milligrams | Geometric Coefficient of Variation 31.8 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (0-2) | NA Milligrams | — |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (8-12) | 9.19 Milligrams | Geometric Coefficient of Variation 50.7 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (2-4) | 55.81 Milligrams | Geometric Coefficient of Variation 47.4 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (24-36) | 4.74 Milligrams | Geometric Coefficient of Variation 42.7 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (4-6) | 21.66 Milligrams | Geometric Coefficient of Variation 66.4 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (12-24) | 11.51 Milligrams | Geometric Coefficient of Variation 36.4 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae(t1-t2) of Gepotidacin | Ae (6-8) | 13.82 Milligrams | Geometric Coefficient of Variation 56.1 |
Secondary
Cohort 2: Ae Total of Gepotidacin in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Ae Total of Gepotidacin in Urine | 312.73 Milligrams |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Ae Total of Gepotidacin in Urine | 156.05 Milligrams |
90% CI: [0.441, 0.565]
Secondary
Cohort 2: AUC(0-24) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: AUC(0-24) of Gepotidacin in Plasma | 17.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 28.6 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: AUC(0-24) of Gepotidacin in Plasma | 8.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 29.6 |
Secondary
Cohort 2: AUC(0-24) of Gepotidacin in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: AUC(0-24) of Gepotidacin in Urine | 3081.3 Hours*micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: AUC(0-24) of Gepotidacin in Urine | 1352.4 Hours*micrograms per milliliter |
90% CI: [0.37, 0.521]
Secondary
Cohort 2: AUC(0-48) of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: AUC(0-48) of Gepotidacin in Plasma | 19.0 Hours*micrograms per milliliter | Geometric Coefficient of Variation 27.7 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: AUC(0-48) of Gepotidacin in Plasma | 9.5 Hours*micrograms per milliliter | Geometric Coefficient of Variation 28.5 |
Secondary
Cohort 2: AUC(0-48) of Gepotidacin in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: AUC(0-48) of Gepotidacin in Urine | 3370.1 Hours*micrograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: AUC(0-48) of Gepotidacin in Urine | 1476.8 Hours*micrograms per milliliter |
90% CI: [0.372, 0.516]
Secondary
Cohort 2: CL/F of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: CL/F of Gepotidacin in Plasma | 77.55 Liters per Hour | Geometric Coefficient of Variation 27.6 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: CL/F of Gepotidacin in Plasma | 155.43 Liters per Hour | Geometric Coefficient of Variation 27.9 |
Secondary
Cohort 2: CLr of Gepotidacin
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: CLr of Gepotidacin | 16.49 Liters per Hour |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: CLr of Gepotidacin | 17.07 Liters per Hour |
90% CI: [0.95, 1.129]
Secondary
Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported.
Time frame: Up to 26 days
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcB Interval | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcF Interval | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcB Interval | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcF Interval | 1 Participants |
Secondary
Cohort 2: Number of Participants With SAE and Non-SAE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.
Time frame: Up to 26 days
Population: Safety Population. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With SAE and Non-SAE | Any SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With SAE and Non-SAE | Any non-SAE | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With SAE and Non-SAE | Any SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With SAE and Non-SAE | Any non-SAE | 2 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 2: Number of Participants With SAE and Non-SAE | Any SAE | 0 Participants |
| Cohort 4: Gepotidacin 1500 mg Fasted | Cohort 2: Number of Participants With SAE and Non-SAE | Any non-SAE | 2 Participants |
Secondary
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 26 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 17 Participants |
Secondary
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 26 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 4 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 16 Participants |
Secondary
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 26 days
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 15 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 1 Participants |
Secondary
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 26 days
Population: Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 14 Participants |
Secondary
Cohort 2: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | 20.85 Percent dose excreted | Geometric Coefficient of Variation 16.9 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | 10.42 Percent dose excreted | Geometric Coefficient of Variation 25.4 |
Secondary
Cohort 2: T1/2 of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: T1/2 of Gepotidacin in Plasma | 10.882 Hours | Geometric Coefficient of Variation 25.5 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: T1/2 of Gepotidacin in Plasma | 10.972 Hours | Geometric Coefficient of Variation 17.2 |
Secondary
Cohort 2: Vz/F of Gepotidacin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 2: Vz/F of Gepotidacin in Plasma | 1217.45 Liters | Geometric Coefficient of Variation 37 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 2: Vz/F of Gepotidacin in Plasma | 2460.46 Liters | Geometric Coefficient of Variation 39.2 |
Secondary
Cohort 3: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose )
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose ) | 1066.21 Milligrams | Geometric Coefficient of Variation 40.4 |
Secondary
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose)
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (0-2), n=17 | NA Milligrams | — |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (2-4), n=18 | 117.61 Milligrams | Geometric Coefficient of Variation 101.7 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (4-6), n=16 | 103.11 Milligrams | Geometric Coefficient of Variation 57.3 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (6-8); n=16 | 70.98 Milligrams | Geometric Coefficient of Variation 53.7 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (8-12), n=18 | 67.42 Milligrams | Geometric Coefficient of Variation 44.3 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (12-14), n=17 | 64.49 Milligrams | Geometric Coefficient of Variation 94.1 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (14-16), n=15 | 142.36 Milligrams | Geometric Coefficient of Variation 142.3 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (16-18), n=14 | 146.89 Milligrams | Geometric Coefficient of Variation 59.4 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (18-20), n=15 | 93.05 Milligrams | Geometric Coefficient of Variation 83.5 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (20-24), n=17 | 74.44 Milligrams | Geometric Coefficient of Variation 93.9 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (24-36), n=18 | 70.01 Milligrams | Geometric Coefficient of Variation 105 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (36-48); n=18 | 20.16 Milligrams | Geometric Coefficient of Variation 46.4 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | Ae (48-60), n=18 | 8.51 Milligrams | Geometric Coefficient of Variation 42.7 |
Secondary
Cohort 3: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | 73.2 Hours*micrograms per milliliter | Geometric Coefficient of Variation 26.8 |
Secondary
Cohort 3: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose)
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) | 14333.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 59.2 |
Secondary
Cohort 3: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | 81.2 Hours*micrograms per milliliter | Geometric Coefficient of Variation 25.9 |
Secondary
Cohort 3: AUC (0-48) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose)
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC (0-48) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) | 16682.1 Hours*micrograms per milliliter | Geometric Coefficient of Variation 59.4 |
Secondary
Cohort 3: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | 41.9 Hours* micrograms per milliliter | Geometric Coefficient of Variation 30.2 |
Secondary
Cohort 3: AUC(0-tau) of Gepotidacin in Plasma First Dose of 3000 mg (First Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-tau) of Gepotidacin in Plasma First Dose of 3000 mg (First Dose) | 29.8 Hours*micrograms per milliliter | Geometric Coefficient of Variation 30.8 |
Secondary
Cohort 3: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose)
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose) | 4770.8 Hours*micrograms per milliliter | Geometric Coefficient of Variation 55.2 |
Secondary
Cohort 3: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | 85.2 Hours*micrograms per milliliter | Geometric Coefficient of Variation 20.1 |
Secondary
Cohort 3: CL/F of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: CL/F of Digoxin in Plasma | 16.26 Liters per Hour |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: CL/F of Digoxin in Plasma | 14.51 Liters per Hour |
90% CI: [0.782, 1.018]
Secondary
Cohort 3: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | 69.99 Liters per Hour | Geometric Coefficient of Variation 20.1 |
Secondary
Cohort 3: CL/F of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: CL/F of Midazolam in Plasma | 80.17 Liters per Hour |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: CL/F of Midazolam in Plasma | 42.16 Liters per Hour |
90% CI: [0.448, 0.618]
Secondary
Cohort 3: CLr of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose)
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: CLr of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) | 13.19 Liters per Hour | Geometric Coefficient of Variation 34.6 |
Secondary
Cohort 3: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) | 7.867 Micrograms per milliliter | Geometric Coefficient of Variation 36.8 |
Secondary
Cohort 3: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | 10.051 Micrograms per milliliter | Geometric Coefficient of Variation 47.7 |
Secondary
Cohort 3: Cmin of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Cmin of Midazolam in Plasma | 0.192 Nanograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Cmin of Midazolam in Plasma | 0.222 Nanograms per milliliter |
90% CI: [0.876, 1.528]
Secondary
Cohort 3: Minimum Observed Concentration (Cmin) of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Minimum Observed Concentration (Cmin) of Digoxin in Plasma | 44.127 Picograms per milliliter |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Minimum Observed Concentration (Cmin) of Digoxin in Plasma | 77.447 Picograms per milliliter |
90% CI: [1.304, 2.363]
Secondary
Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported.
Time frame: Up to 30 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcB Interval | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcF Interval | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcB Interval | 5 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval | QTcF Interval | 0 Participants |
Secondary
Cohort 3: Number of Participants With SAE and Non-SAE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.
Time frame: Up to 30 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With SAE and Non-SAE | Any SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With SAE and Non-SAE | Any non-SAE | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With SAE and Non-SAE | Any SAE | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With SAE and Non-SAE | Any non-SAE | 11 Participants |
Secondary
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 30 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | ALT; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Albumin; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Alk Phos; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | AST; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Calcium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Carbon Dioxide; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Chloride; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatine Kinase; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Creatinine; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Direct Bilirubin; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Magnesium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Potassium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | Sodium; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline | BUN; To Normal or No Change | 17 Participants |
Secondary
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline
Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 30 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Lymphocytes; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To High | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Erythrocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Monocytes; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Low | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Basophils; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Eosinophils; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hematocrit; To High | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Platelets; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Low | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Neutrophils; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | MCV; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline | Hemoglobin; To Normal or No Change | 15 Participants |
Secondary
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 30 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 6 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 14 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 5 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Chan | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 3 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Bilirubin; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Occult Blood; To Abnormal | 5 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Glucose; To Abnormal | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To High | 8 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Normal or No Change | 17 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Normal or No Change | 16 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Ketones; To Abnormal | 1 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Normal or No Change | 13 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Protein; To Abnormal | 2 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Leukocyte Esterase; To Abnormal | 5 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Specific Gravity; To Normal or No Chan | 10 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | pH; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline | Nitrite; To Abnormal | 0 Participants |
Secondary
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline
Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
Time frame: Up to 30 days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 19 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | DBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To High | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Low | 0 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | Pulse rate; To Normal or No Change | 18 Participants |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline | SBP; To Low | 0 Participants |
Secondary
Cohort 3: Percentage of the Given Dose of Drug Excreted in Urine (fe%) Following Two 3000 mg Doses of Gepotidacin (First Dose + Second Dose )
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Percentage of the Given Dose of Drug Excreted in Urine (fe%) Following Two 3000 mg Doses of Gepotidacin (First Dose + Second Dose ) | 17.77 Percent dose excreted | Geometric Coefficient of Variation 40.4 |
Secondary
Cohort 3: RoAUC of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: RoAUC of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | 1.406 Ratio | Geometric Coefficient of Variation 27.5 |
Secondary
Cohort 3: RoCmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: RoCmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | 1.278 Ratio | Geometric Coefficient of Variation 54.4 |
Secondary
Cohort 3: T1/2 of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: T1/2 of Digoxin in Plasma | 39.367 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: T1/2 of Digoxin in Plasma | 32.777 Hours |
90% CI: [0.769, 0.902]
Secondary
Cohort 3: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose+ Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose+ Second Dose) | 9.501 Hours | Geometric Coefficient of Variation 22.5 |
Secondary
Cohort 3: T1/2 of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: T1/2 of Midazolam in Plasma | 5.320 Hours |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: T1/2 of Midazolam in Plasma | 6.075 Hours |
90% CI: [1.016, 1.283]
Secondary
Cohort 3: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) | 0.250 Hours |
Secondary
Cohort 3: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose) | 2.500 Hours |
Secondary
Cohort 3: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose) | 2.000 Hours |
Secondary
Cohort 3: Vz/F of Digoxin in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Vz/F of Digoxin in Plasma | 923.75 Liters |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Vz/F of Digoxin in Plasma | 688.49 Liters |
90% CI: [0.653, 0.85]
Secondary
Cohort 3: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose) | 959.42 Liters | Geometric Coefficient of Variation 30 |
Secondary
Cohort 3: Vz/F of Midazolam in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 3: Vz/F of Midazolam in Plasma | 615.36 Liters |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 3: Vz/F of Midazolam in Plasma | 371.24 Liters |
90% CI: [0.521, 0.699]
Secondary
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (4-6) | 60.05 Milligrams | Geometric Coefficient of Variation 57 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (0-2) | NA Milligrams | — |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (2-4) | 102.23 Milligrams | Geometric Coefficient of Variation 25.2 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (6-8) | 31.61 Milligrams | Geometric Coefficient of Variation 48.9 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (8-12) | 16.51 Milligrams | Geometric Coefficient of Variation 97 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (12-24) | 17.16 Milligrams | Geometric Coefficient of Variation 49.3 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (24-36) | 5.72 Milligrams | Geometric Coefficient of Variation 196.5 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | Ae (36-48) | 4.28 Milligrams | Geometric Coefficient of Variation 63.2 |
Secondary
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (0-2); n=11 | NA Milligrams | — |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (2-4); n=10 | 221.19 Milligrams | Geometric Coefficient of Variation 56.7 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (4-6); n=11 | 103.68 Milligrams | Geometric Coefficient of Variation 70.6 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (6-8); n=11 | 67.58 Milligrams | Geometric Coefficient of Variation 49.5 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (8-12); n=11 | 65.06 Milligrams | Geometric Coefficient of Variation 22.7 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (12-14); n=11 | 112.83 Milligrams | Geometric Coefficient of Variation 66.3 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (14-16); n=11 | 174.62 Milligrams | Geometric Coefficient of Variation 85.2 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (16-18); n=11 | 136.66 Milligrams | Geometric Coefficient of Variation 68.1 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (18-20); n=11 | 90.81 Milligrams | Geometric Coefficient of Variation 25.4 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (20-24); n=11 | 80.54 Milligrams | Geometric Coefficient of Variation 20.4 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (24-36); n=11 | 57.62 Milligrams | Geometric Coefficient of Variation 42.9 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (36-48); n=11 | 14.47 Milligrams | Geometric Coefficient of Variation 36.9 |
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | Ae (48-60); n=10 | 9.67 Milligrams | Geometric Coefficient of Variation 61.7 |
Secondary
Cohort 4: Ae Total of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae Total of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | 293.50 Milligrams | Geometric Coefficient of Variation 29 |
Secondary
Cohort 4: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | 1334.42 Milligrams | Geometric Coefficient of Variation 25.4 |
Secondary
Cohort 4: AUC(0-24) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-24) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | 2142.4 Hours*micrograms per milliliter | Geometric Coefficient of Variation 53.5 |
Secondary
Cohort 4: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | 14729.5 Hours*micrograms per milliliter | Geometric Coefficient of Variation 59.3 |
Secondary
Cohort 4: AUC(0-48) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-48) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | 2293.7 Hours*micrograms per milliliter | Geometric Coefficient of Variation 53.2 |
Secondary
Cohort 4: AUC(0-48) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-48) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | 15768.2 Hours*micrograms per milliliter | Geometric Coefficient of Variation 58.8 |
Secondary
Cohort 4: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State | 4996.9 Hours*micrograms per milliliter | Geometric Coefficient of Variation 64.4 |
Secondary
Cohort 4: CL/F of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: CL/F of Gepotidacin Following Single Dose of 1500 mg in Plasma | 67.26 Liters per Hour | Geometric Coefficient of Variation 15.5 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: CL/F of Gepotidacin Following Single Dose of 1500 mg in Plasma | 73.50 Liters per Hour | Geometric Coefficient of Variation 13.3 |
Secondary
Cohort 4: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | 68.83 Liters per Hour | Geometric Coefficient of Variation 13.9 |
Secondary
Cohort 4: CLr of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: CLr of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition | 13.42 Liters per Hour | Geometric Coefficient of Variation 31.9 |
Secondary
Cohort 4: CLr of Gepotidacin Following Two 3000 mg Dose-Fed State
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: CLr of Gepotidacin Following Two 3000 mg Dose-Fed State | 14.61 Liters per Hour | Geometric Coefficient of Variation 19.3 |
Secondary
Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) for Gepotidacin 1500 mg Under Fed Condition
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100%.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) for Gepotidacin 1500 mg Under Fed Condition | 19.57 Percent dose excreted | Geometric Coefficient of Variation 29 |
Secondary
Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin Following Two 3000 mg Doses-Fed State
Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin Following Two 3000 mg Doses-Fed State | 22.24 Percent dose excreted | Geometric Coefficient of Variation 25.4 |
Secondary
Cohort 4: T1/2 of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: T1/2 of Gepotidacin Following Single Dose of 1500 mg in Plasma | 12.848 Hours | Geometric Coefficient of Variation 28.5 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: T1/2 of Gepotidacin Following Single Dose of 1500 mg in Plasma | 12.540 Hours | Geometric Coefficient of Variation 14.2 |
Secondary
Cohort 4: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose )-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose )-Fed State | 12.599 Hours | Geometric Coefficient of Variation 36.6 |
Secondary
Cohort 4: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)-Fed State | 0 Hours |
Secondary
Cohort 4: Vz/F of Gepotidacin Following Single Dose of 1500 mg in Plasma
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Vz/F of Gepotidacin Following Single Dose of 1500 mg in Plasma | 1246.70 Liters | Geometric Coefficient of Variation 38.8 |
| Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg | Cohort 4: Vz/F of Gepotidacin Following Single Dose of 1500 mg in Plasma | 1329.83 Liters | Geometric Coefficient of Variation 17.7 |
Secondary
Cohort 4: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State
Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.
Time frame: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3
Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State | 1251.05 Liters | Geometric Coefficient of Variation 34.5 |
Other Pre-specified
Cohort 4: AUC(0-tau) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine
Urine samples were collected at indicated time points. AUC(0-tau) can be calculated only for multiple doses and not for single dose as tau refers to the dosing interval. Hence, AUC(0-tau) could not be calculated for Gepotidacin 1500 mg single dose as mentioned in Reporting and Analysis Plan. The results for this outcome measure will never be posted.
Time frame: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2
Population: Pharmacokinetic Parameter Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Gepotidacin 1500 mg | Cohort 4: AUC(0-tau) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine | NA Hours*micrograms per milliliter |