Infections, Bacterial
Conditions
Keywords
GSK2140944, Gepotidacin, Pharmacokinetics, Healthy Adult, Healthy adolescent
Brief summary
This is double-blind, randomized, sequential, two part study. Part 1 is a 3 periods, fixed-sequence study and will be conducted to evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adult subjects. Part 2 is a 2 periods, fixed-sequence study and will evaluate the pharmacokinetics, safety, and tolerability of the gepotidacin tablet in healthy adolescent subjects. The primary purpose of Part 1 is to evaluate the pharmacokinetics of a single 1500 milligram (mg) dose and two 3000 mg doses of gepotidacin given 6 and 12 hours apart in adult subjects; Part 2 is to evaluate the pharmacokinetics of a single 1500 mg dose and two 3000 mg doses of gepotidacin given at a dosing interval (to be determined based on the pharmacokinetic and safety results from Part 1) in adolescent subjects. The duration of Part A will be approximately 47 days and 52 days for Part 2.
Interventions
DRUGGepotidacin
Tablets containing gepotidacin mesylate with a unit dose of 750 mg will be administered orally with 240 milliliter (mL) of water.
DRUGPlacebo
Tablets containing unit dose of placebo matching of gepotidacin will be administered orally with 240 mL of water.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blind study.
Intervention model description
Part 1 is a 3-period, fixed-sequence study of a single 1500-mg dose (Period 1) and two 3000-mg doses of gepotidacin at Hours 0 and 12 (Period 2) and Hours 0 and 6 (Period 3) in healthy adult subjects. Part 2 is a 2-period, fixed sequence study of a single 1500 mg dose (Period 1) of gepotidacin and two 3000 mg doses (Period 2) of gepotidacin in healthy adolescent subjects. .
Eligibility
Sex/Gender
ALL
Age
12 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects in Part 1 must be \>=18 to \<=64 years of age inclusive, at the time of signing the informed consent. * Subjects in Part 2 must be \>=12 to \<18 years of age inclusive, at the time of signing the informed consent/assent. * Subjects 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 \<450 millisecond (msec). A subject 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. * Body weight \>=40 kilogram (kg) and body mass index (BMI) within the range 18.5 - 32.0 kg per square meter (inclusive). * Male and/or female. * Female subjects: A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) Is not a woman of childbearing potential (WOCBP), or b) Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of \<1% for at least 30 days prior to dosing until completion of the follow-up visit. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a highly sensitive negative pregnancy test before the first dose of study intervention. * Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form/assent and 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 subject at risk or interfere with outcome variables of the study. This includes, but is not limited to, history or current cardiac, hepatic, renal, neurologic, gastrointestinal (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 subject at risk, in the opinion of the investigator. * Female subject has a positive pregnancy test result or is lactating at screening or upon admission to the clinic. * Use of any systemic antibiotic within 30 days of screening. * Within 2 months before screening, either a confirmed history of Clostridium difficile diarrhea infection or a past positive of Clostridium 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 to any of the study drug, components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GlaxoSmithKline medical monitor contraindicates their participation. * History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic uses heparin to maintain intravenous cannula patency). * Subject must abstain from taking prescription or non-prescription drugs (except for hormonal contraceptives and/or acetaminophen), 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 within 12 months prior to starting study intervention. * Subject has participated in a clinical trial and has received an investigational product prior to gepotidacin administration within 30 days, 5 half-lives, or twice the duration of the biological effect of investigational product (whichever is longer). * Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. * ALT \>1.5 \* upper limit of normal (ULN). * Bilirubin \>1.5 \* ULN (isolated bilirubin \>1.5 \* ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * History of any kidney disease or current or chronic history of impaired renal function as indicated by an estimated creatinine clearance \<60 milliliter per minute (mL/min). * A positive test for human immunodeficiency virus 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. * Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months before screening. * Clinically significant abnormal findings in serum chemistry, hematology, or urinalysis results obtained at screening or Day -1. * Baseline corrected QT interval using the Fridericia formula (QTcF) of \>450 msec. * Subject 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. * Subject is unable to comply with all study procedures, in the opinion of the investigator. * Subject should not participate in the study, in the opinion of the investigator or sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose. |
| Part 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed 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. |
| Part 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose. |
| Part 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed 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. |
| Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. |
| Part 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis |
| Part 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis |
| Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Day 19 | 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 any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs is presented. |
| Part 2: Number of Participants With Non-serious AEs and SAEs | Up to Day 21 | 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 any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs are presented. |
| Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher | Up to Day 19 | Blood samples were collected for the analysis of following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented. |
| Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher | Up to Day 21 | Blood samples were collected for the analysis of following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented. |
| Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | Up to Day 19 | Blood samples were collected for the analysis of following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose (fasting), potassium, sodium, magnesium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented |
| Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | Up to Day 21 | Blood samples were collected for the analysis of following clinical chemistry parameters: BUN, creatinine, glucose (fasting), potassium, sodium, magnesium, AST, ALT, alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented |
| Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | Up to Day 19 | Urine samples were collected for the analysis of urine parameters including specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented |
| Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | Up to Day 21 | Urine samples were collected for the analysis of urine parameters including specific gravity, pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented |
| Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance | Up to Day 19 | SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 millimeters of mercury \[mmHg\]) and DBP (lower: \<45 and upper: \>100 mmHg). |
| Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance | Up to Day 21 | SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 mmHg) and DBP (lower: \<45 and upper: \>100 mmHg). |
| Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | Up to Day 19 | Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute). |
| Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | Up to Day 21 | Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute). |
| Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3. | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3 | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3 | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3 | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3 | A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Part 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at the specified intervals for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Part 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose. | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were be collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100 percent (%). |
| Part 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t) |
| Part 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Part 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals |
| Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals |
| Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18 -24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Part 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8 and 8-12 hours post-dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine) | Pre-dose, 0-2, 2-4 and 4-6 hours post-dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin |
| Part 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20 and 20-24 hours post dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin |
| Part 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin |
| Part 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%. |
| Part 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%. |
| Part 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t) |
| Part 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t) |
| Part 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals |
| Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | 0-2, 2-4, 4-6, 6-8, 8-12, 12-24,24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose. | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%. |
| Part 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t). |
| Part 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Part 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose. | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin |
| Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals. |
| Part 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6 hours post-dose | Urine samples will be collected at indicated time points for pharmacokinetic analysis of gepotidacin |
| Part 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine) | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose | Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. |
| Part 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%. |
| Part 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose | Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t). |
| Part 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
| Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose | Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis. |
Countries
United States
Participant flow
Recruitment details
This was a two-part, double-blind, randomized, sequential study to evaluate pharmacokinetics of Gepotidacin in healthy adult and adolescent participants. The study was conducted at a single center in the United States.
Pre-assignment details
A total of 34 participants were randomized in this study (Randomized Population): 16 adult participants in Part 1 and 18 adolescent participants in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| Gepotidacin (A/C/E) Adult participants were randomized to receive a single dose of gepotidacin 1500 milligrams (mg) (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 12 hours (Treatment C) on Day 5 of Period 2, and two doses of gepotidacin 3000 mg separated by 6 hours (Treatment E) on Day 9 of Period 3. All doses were administered orally with water after consumption of food. | 14 |
| Placebo (B/D/F) Adult participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 12 hours (Treatment D) on Day 5 of Period 2, and two doses of gepotidacin matching placebo separated by 6 hours (Treatment F) on Day 9 of Period 3. All doses were administered orally with water after consumption of food. | 2 |
| Gepotidacin (A/G) Adolescent participants were randomized to receive a single dose of gepotidacin 1500 mg (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 6 hours (Treatment G) on Day 1 of Period 2. All doses were administered orally with water after consumption of food. | 14 |
| Placebo (B/H) Adolescent participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 6 hours (Treatment H) on Day 1 of Period 2. All doses were administered orally with water after consumption of food. | 3 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Part 1, Period 1(Day 1 to Day 4) | Withdrawal by Subject | 1 | 0 | 0 | 0 |
| Part 2, Period 1 (Day 1 to Day 3) | Unable to swallow | 0 | 0 | 2 | 0 |
| Part 2, Period 1 (Day 1 to Day 3) | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Gepotidacin (A/C/E) | Placebo (B/D/F) | Gepotidacin (A/G) | Placebo (B/H) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 14 Participants | 3 Participants | 17 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 2 Participants | 0 Participants | 0 Participants | 16 Participants |
| Race/Ethnicity, Customized Asian- Central/South Asian Heritage | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 0 Participants | 6 Participants | 1 Participants | 13 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White-Arabic/North African Heritage | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-White/Caucasian/European Heritage | 6 Participants | 2 Participants | 5 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Female | 6 Participants | 1 Participants | 4 Participants | 1 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 1 Participants | 10 Participants | 2 Participants | 21 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 14 | 0 / 13 | 0 / 13 | 0 / 3 | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 0 / 2 | 1 / 14 | 10 / 13 | 9 / 13 | 2 / 3 | 9 / 14 | 12 / 12 |
| serious Total, serious adverse events | 0 / 2 | 0 / 14 | 0 / 13 | 0 / 13 | 0 / 3 | 0 / 14 | 0 / 12 |
Outcome results
Primary
Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance
Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).
Time frame: Up to Day 19
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 3000 mg 6 Hour Interval | Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | 1 Participants |
Primary
Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher
Blood samples were collected for the analysis of following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose (fasting), potassium, sodium, magnesium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented
Time frame: Up to Day 19
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 6 Hour Interval | Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | 0 Participants |
Primary
Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher
Blood samples were collected for the analysis of following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.
Time frame: Up to Day 19
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 6 Hour Interval | Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher | 0 Participants |
Primary
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs is presented.
Time frame: Up to Day 19
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Common non-serious AEs | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Common non-serious AEs | 1 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Common non-serious AEs | 10 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Part 1: Gepotidacin 3000 mg 6 Hour Interval | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | Common non-serious AEs | 9 Participants |
| Part 1: Gepotidacin 3000 mg 6 Hour Interval | Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Primary
Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance
SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 millimeters of mercury \[mmHg\]) and DBP (lower: \<45 and upper: \>100 mmHg).
Time frame: Up to Day 19
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance | 1 Participants |
| Part 1: Gepotidacin 3000 mg 6 Hour Interval | Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance | 1 Participants |
Primary
Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher
Urine samples were collected for the analysis of urine parameters including specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented
Time frame: Up to Day 19
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 6 Hour Interval | Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | 0 Participants |
Primary
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg | 20.15 Hours*micrograms per milliliter | Geometric Coefficient of Variation 16.8 |
Primary
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg | 18.66 Hours*micrograms per milliliter | Geometric Coefficient of Variation 19.5 |
Primary
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg | 19.72 Hours*micrograms per milliliter | Geometric Coefficient of Variation 17.6 |
Primary
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter Population consisted of all participants in the PK Population (participants who received at least 1 dose of gepotidacin and had evaluable post-dose plasma concentration data for gepotidacin), for whom valid and evaluable PK parameters were derived.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg | 19.69 Hours*micrograms per milliliter | Geometric Coefficient of Variation 17.6 |
Primary
Part 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg | 3.574 Micrograms per milliliter | Geometric Coefficient of Variation 38.1 |
Primary
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3.
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 1 hour, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- predose, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- predose 2, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1-predose 2, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- predose 3, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- predose 3, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 0.5 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 0.5 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- predose, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 1 hour, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 1.5 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 1.5 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 2 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 2 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 2.5 hours, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 2.5 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 3 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 3 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 4 hours, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 4 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 6 hours, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 6 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 8 hours, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 8 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 12 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 12 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 2- 24 hours, n= 2, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 2- 24 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 2- 36 hours, n= 2, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 2- 36 hours, n= 2, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 3- 48 hours, n= 2, 13 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 3- 48 hours, n= 2, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 3- 48 hours, n= 2, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- predose, n= 2, 14 | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 3 hours, n= 2, 14 | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- predose, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 12 hours, n= 2, 14 | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- predose 2, n= 2, 14 | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 3 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1-predose 2, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 2- 36 hours, n= 2, 13 | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- predose 3, n= 2, 14 | 12 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 4 hours, n= 2, 14 | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- predose 3, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 12 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 0.5 hours, n= 2, 14 | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 4 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 0.5 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 3- 48 hours, n= 2, 13 | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 1 hour, n= 2, 14 | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 6 hours, n= 2, 14 | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 1 hour, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 2- 24 hours, n= 2, 14 | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 1.5 hours, n= 2, 14 | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 6 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 1.5 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 2- 36 hours, n= 2, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 2 hours, n= 2, 14 | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 8 hours, n= 2, 14 | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 2 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 2- 24 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, NCS, Day 1- 2.5 hours, n= 2, 14 | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 8 hours, n= 2, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Abnormal, CS, Day 1- 2.5 hours, n= 2, 14 | 0 Participants |
Primary
Part 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed 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, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | 1.164 Ratio | Geometric Coefficient of Variation 12.7 |
Primary
Part 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed 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, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | 1.109 Ratio | Geometric Coefficient of Variation 30.6 |
Primary
Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Dose 1 | 38.15 Hours*micrograms per milliliter | Geometric Coefficient of Variation 24.3 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Dose 2 | 44.41 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22.8 |
Primary
Part 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 and 24 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | 83.45 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22.7 |
Primary
Part 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | 90.53 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22.7 |
Primary
Part 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | 91.21 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22.6 |
Primary
Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Dose 1 | 9.937 Micrograms per milliliter | Geometric Coefficient of Variation 24.2 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval | Dose 2 | 11.02 Micrograms per milliliter | Geometric Coefficient of Variation 28.1 |
Primary
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 13 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 13 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 13.5 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 13.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14.5 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 15 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 15 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 16 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 16 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 18 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 18 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 20 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 20 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 24 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 24 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 36 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 48 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2 | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 48 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 60 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 60 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 60 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2 | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3 | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12.5 hours | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 13 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 13 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 13.5 hours | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 13.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14.5 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 15 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 15 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 16 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 16 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 18 hours | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 18 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 20 hours | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 20 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 24 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 24 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 36 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 48 hours | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 48 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 60 hours | 5 Participants |
Primary
Part 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | 82.43 Hours*micrograms per milliliter | Geometric Coefficient of Variation 27.3 |
Primary
Part 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | 86.49 Hours*micrograms per milliliter | Geometric Coefficient of Variation 26.4 |
Primary
Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Dose 1 | 24.09 Hours*micrograms per milliliter | Geometric Coefficient of Variation 33.6 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Dose 2 | 40.13 Hours*micrograms per milliliter | Geometric Coefficient of Variation 29.5 |
Primary
Part 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | 87.09 Hours*micrograms per milliliter | Geometric Coefficient of Variation 26.3 |
Primary
Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Dose 1 | 8.423 Micrograms per milliliter | Geometric Coefficient of Variation 41.8 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | Dose 2 | 13.01 Micrograms per milliliter | Geometric Coefficient of Variation 28.6 |
Primary
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8.5 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 48 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 9 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 9 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 10 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 10 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 18 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 18 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 24 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 24 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 48 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 60 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 60 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8.5 hours | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7.5 hours | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2 | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3 | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6.5 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 9 hours | 11 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 9 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 10 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 10 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 18 hours | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 18 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 24 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 24 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 2- 36 hours | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 2- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 48 hours | 10 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 48 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 3- 60 hours | 8 Participants |
| Part 1: Gepotidacin 1500 mg | Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 3- 60 hours | 0 Participants |
Primary
Part 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed 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, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | 1.666 Ratio | Geometric Coefficient of Variation 25.9 |
Primary
Part 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed 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, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval | 1.544 Ratio | Geometric Coefficient of Variation 25.9 |
Primary
Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance
Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).
Time frame: Up to Day 21
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | 1 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance | 0 Participants |
Primary
Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher
Blood samples were collected for the analysis of following clinical chemistry parameters: BUN, creatinine, glucose (fasting), potassium, sodium, magnesium, AST, ALT, alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented
Time frame: Up to Day 21
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | 1 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher | 3 Participants |
Primary
Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher
Blood samples were collected for the analysis of following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.
Time frame: Up to Day 21
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher | 0 Participants |
Primary
Part 2: Number of Participants With Non-serious AEs and SAEs
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 any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs are presented.
Time frame: Up to Day 21
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | Common non-serious AEs | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | Common non-serious AEs | 9 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 2: Number of Participants With Non-serious AEs and SAEs | Common non-serious AEs | 12 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 2: Number of Participants With Non-serious AEs and SAEs | SAEs | 0 Participants |
Primary
Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance
SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 mmHg) and DBP (lower: \<45 and upper: \>100 mmHg).
Time frame: Up to Day 21
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance | 0 Participants |
Primary
Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher
Urine samples were collected for the analysis of urine parameters including specific gravity, pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented
Time frame: Up to Day 21
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | 0 Participants |
| Part 1: Gepotidacin 3000 mg 12 Hour Interval | Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher | 0 Participants |
Primary
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg | 22.06 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22.6 |
Primary
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg | 23.27 Hours*micrograms per milliliter | Geometric Coefficient of Variation 21.6 |
Primary
Part 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg | 23.79 Hours*micrograms per milliliter | Geometric Coefficient of Variation 20.9 |
Primary
Part 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg | 23.27 Hours*micrograms per milliliter | Geometric Coefficient of Variation 21.6 |
Primary
Part 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg | 4.523 Micrograms per milliliter | Geometric Coefficient of Variation 29.5 |
Primary
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3
Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose, n= 3, 14 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours, n= 3, 13 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours, n= 3, 13 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 24 hours, n= 3, 13 | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 24 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 36 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 36 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 48 hours, n= 3, 13 | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 48 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 48 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose, n= 3, 14 | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours, n= 3, 13 | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours, n= 3, 13 | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2, n= 3, 14 | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 36 hours, n= 3, 13 | 3 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3, n= 3, 14 | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours, n= 3, 14 | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours, n= 3, 14 | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours, n= 3, 14 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 48 hours, n= 3, 13 | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour, n= 3, 13 | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours, n= 3, 13 | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 24 hours, n= 3, 13 | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours, n= 3, 13 | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 36 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours, n= 3, 13 | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours, n= 3, 13 | 3 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 24 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours, n= 3, 13 | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours, n= 3, 13 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours, n= 3, 13 | 0 Participants |
Primary
Part 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | 111.4 Hours*micrograms per milliliter | Geometric Coefficient of Variation 23.8 |
Primary
Part 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | 115.6 Hours*micrograms per milliliter | Geometric Coefficient of Variation 23.8 |
Primary
Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Dose 1 | 32.37 Hours*micrograms per milliliter | Geometric Coefficient of Variation 22 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Dose 2 | 53.85 Hours*micrograms per milliliter | Geometric Coefficient of Variation 26.7 |
Primary
Part 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | 115.6 Hours*micrograms per milliliter | Geometric Coefficient of Variation 23.8 |
Primary
Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Dose 1 | 10.86 Micrograms per milliliter | Geometric Coefficient of Variation 26.8 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval | Dose 2 | 14.29 Micrograms per milliliter | Geometric Coefficient of Variation 29.5 |
Primary
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3 | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6.5 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 9 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 9 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 10 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 10 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 18 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 18 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 24 hours | 1 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 24 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 48 hours | 2 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 48 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 48 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7 hours | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 12 hours | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 2 | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1-predose 2 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 24 hours | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- predose 3 | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 7.5 hours | 3 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- predose 3 | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 12 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 0.5 hours | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 7.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 0.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 36 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1 hour | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8 hours | 3 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1 hour | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 14 hours | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 1.5 hours | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 1.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 24 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2 hours | 6 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 8.5 hours | 3 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 14 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 2.5 hours | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 8.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 2.5 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 48 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 3 hours | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 9 hours | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 3 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 18 hours | 7 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 4 hours | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 9 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 4 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 36 hours | 4 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6 hours | 3 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 10 hours | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 18 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, NCS, Day 1- 6.5 hours | 5 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 10 hours | 0 Participants |
| Part 1: Gepotidacin 1500 mg | Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings | Abnormal, CS, Day 1- 6.5 hours | 0 Participants |
Secondary
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at the specified intervals for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (0-2), n=14 | 50.87 Milligrams | Standard Deviation 61.194 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (2-4), n=13 | 92.98 Milligrams | Standard Deviation 51.315 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (4-6), n=13 | 68.14 Milligrams | Standard Deviation 39.927 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (6-8), n=14 | 47.68 Milligrams | Standard Deviation 25.551 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (8-12), n=14 | 35.71 Milligrams | Standard Deviation 11.458 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (12-24), n=14 | 29.10 Milligrams | Standard Deviation 7.8849 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (24-36), n=13 | 10.72 Milligrams | Standard Deviation 4.233 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg | Ae (36-48), n=13 | 5.601 Milligrams | Standard Deviation 2.0351 |
Secondary
Part 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | 3340.0 Hours*micrograms per milliliter | Standard Deviation 2340.34 |
Secondary
Part 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Urine samples were be collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | 3567.9 Hours*micrograms per milliliter | Standard Deviation 2377.71 |
Secondary
Part 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg | 0.000 Hours |
Secondary
Part 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100 percent (%).
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg | 21.874 Percent dose excreted | Standard Deviation 4.5393 |
Secondary
Part 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg | 16.66 Liters per hour | Standard Deviation 3.4123 |
Secondary
Part 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg | 11.533 Hours | Geometric Coefficient of Variation 36.2 |
Secondary
Part 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg | 3.000 Hours |
Secondary
Part 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated 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, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg | 328.1 Milligrams | Standard Deviation 68.09 |
Secondary
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals
Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (0-2), n=13 | 158.5 Milligrams | Standard Deviation 81.599 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (2-4), n=12 | 186.1 Milligrams | Standard Deviation 73.777 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (4-6), n=13 | 143.6 Milligrams | Standard Deviation 73.79 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (6-8), n=12 | 66.80 Milligrams | Standard Deviation 22.886 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (8-12), n=13 | 64.98 Milligrams | Standard Deviation 23.987 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (12-14), n=12 | 204.1 Milligrams | Standard Deviation 113.98 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (14-16), n=13 | 254.3 Milligrams | Standard Deviation 83.985 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (16-18), n=12 | 156.7 Milligrams | Standard Deviation 85.023 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (18-20), n=13 | 80.29 Milligrams | Standard Deviation 43.563 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (20-24), n=13 | 79.23 Milligrams | Standard Deviation 25.216 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (24-36), n=13 | 74.53 Milligrams | Standard Deviation 21.862 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (36-48), n=13 | 20.35 Milligrams | Standard Deviation 5.7977 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Ae (48-60), n=13 | 10.51 Milligrams | Standard Deviation 5.0038 |
Secondary
Part 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | 1452.7 Milligrams | Standard Deviation 223.1 |
Secondary
Part 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20 and 20-24 hours post dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine) | 17431.6 Hours*micrograms per milliliter | Standard Deviation 10132.84 |
Secondary
Part 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine) | 19128.3 Hours*micrograms per milliliter | Standard Deviation 10934.06 |
Secondary
Part 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8 and 8-12 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine) | 7287.4 Hours*micrograms per milliliter | Standard Deviation 4050.81 |
Secondary
Part 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | 15.88 Liters per hour | Standard Deviation 2.0305 |
Secondary
Part 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | 24.212 Percent dose excreted | Standard Deviation 3.7184 |
Secondary
Part 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | 10.976 Hours | Geometric Coefficient of Variation 27.3 |
Secondary
Part 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | 0.000 Hours |
Secondary
Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Dose 1 | 2.000 Hours |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval | Dose 2 | 1.567 Hours |
Secondary
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18 -24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (0-2), n=12 | 97.51 Milligrams | Standard Deviation 70.551 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (2-4), n=10 | 216.8 Milligrams | Standard Deviation 97.543 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (4-6), n=13 | 172.2 Milligrams | Standard Deviation 98.842 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (6-8), n=12 | 242.3 Milligrams | Standard Deviation 138.61 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (8-10), n=11 | 251.0 Milligrams | Standard Deviation 115.23 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (10-12), n=12 | 151.6 Milligrams | Standard Deviation 91.694 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (12-14), n=12 | 107.3 Milligrams | Standard Deviation 77.898 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (14-18), n=12 | 72.83 Milligrams | Standard Deviation 27.363 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (18-24), n=12 | 63.91 Milligrams | Standard Deviation 48.404 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (24-36), n=13 | 39.13 Milligrams | Standard Deviation 12.057 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (36-48), n=13 | 15.64 Milligrams | Standard Deviation 5.958 |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Ae (48-60), n=13 | 8.889 Milligrams | Standard Deviation 4.1747 |
Secondary
Part 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | 1293.9 Milligrams | Standard Deviation 367.48 |
Secondary
Part 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine) | 13174.1 Hours*micrograms per milliliter | Standard Deviation 8648.92 |
Secondary
Part 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine) | 14277.1 Hours*micrograms per milliliter | Standard Deviation 9045.37 |
Secondary
Part 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Time frame: Pre-dose, 0-2, 2-4 and 4-6 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine) | 3943.5 Hours*micrograms per milliliter | Standard Deviation 3015.98 |
Secondary
Part 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | 14.81 Liters per hour | Standard Deviation 3.4456 |
Secondary
Part 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | 21.565 Percent dose excreted | Standard Deviation 6.1246 |
Secondary
Part 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | 12.020 Hours | Geometric Coefficient of Variation 14.6 |
Secondary
Part 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | 0.000 Hours |
Secondary
Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Dose 1 | 2.633 Hours |
| Part 1: Gepotidacin 1500 mg | Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval | Dose 2 | 1.500 Hours |
Secondary
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: 0-2, 2-4, 4-6, 6-8, 8-12, 12-24,24-36 and 36-48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (4-6), n=12 | 85.47 Milligrams | Standard Deviation 37.814 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (0-2), n=13 | 16.00 Milligrams | Standard Deviation 28.532 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (2-4), n=12 | 130.5 Milligrams | Standard Deviation 49.526 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (6-8), n=13 | 58.74 Milligrams | Standard Deviation 32.586 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (8-12), n=13 | 40.15 Milligrams | Standard Deviation 14.232 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (12-24), n=13 | 30.87 Milligrams | Standard Deviation 11.638 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (24-36), n=13 | 10.11 Milligrams | Standard Deviation 4.6348 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg | Ae (36-48), n=13 | 6.312 Milligrams | Standard Deviation 2.5619 |
Secondary
Part 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg | 361.5 Milligrams | Standard Deviation 83.95 |
Secondary
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | 4513.7 Hours*micrograms per milliliter | Standard Deviation 2623.81 |
Secondary
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine) | 4948.4 Hours*micrograms per milliliter | Standard Deviation 2721.49 |
Secondary
Part 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg | 15.56 Liters per hour | Standard Deviation 3.7934 |
Secondary
Part 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg | 24.100 Percent dose excreted | Standard Deviation 5.5968 |
Secondary
Part 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg | 12.984 Hours | Geometric Coefficient of Variation 16.6 |
Secondary
Part 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg | 0.500 Hours |
Secondary
Part 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg | 3.000 Hours |
Secondary
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Time frame: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (0-2), n=11 | 105.3 Milligrams | Standard Deviation 121.67 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (2-4), n=10 | 202.0 Milligrams | Standard Deviation 70.108 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (4-6), n=10 | 229.7 Milligrams | Standard Deviation 113.95 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (6-8), n=11 | 244.9 Milligrams | Standard Deviation 149.66 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (8-10), n=12 | 446.6 Milligrams | Standard Deviation 138.33 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (10-12), n=10 | 228.3 Milligrams | Standard Deviation 79.619 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (12-14), n=11 | 172.5 Milligrams | Standard Deviation 63.15 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (14-18), n=10 | 132.6 Milligrams | Standard Deviation 51.586 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (18-24), n=10 | 67.56 Milligrams | Standard Deviation 40.521 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (24-36), n=12 | 61.99 Milligrams | Standard Deviation 51.367 |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Ae (36-48), n=12 | 14.86 Milligrams | Standard Deviation 8.321 |
Secondary
Part 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | 1719.4 Milligrams | Standard Deviation 402.71 |
Secondary
Part 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine) | 22052.8 Hours*micrograms per milliliter | Standard Deviation 11410.09 |
Secondary
Part 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose.
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine) | 24500.7 Hours*micrograms per milliliter | Standard Deviation 12281.23 |
Secondary
Part 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
Urine samples will be collected at indicated time points for pharmacokinetic analysis of gepotidacin
Time frame: Pre-dose, 0-2, 2-4, 4-6 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine) | 5364.4 Hours*micrograms per milliliter | Standard Deviation 2877.94 |
Secondary
Part 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | 14.93 Liters per hour | Standard Deviation 3.9558 |
Secondary
Part 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Time frame: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | 28.657 Percent dose excreted | Standard Deviation 6.7119 |
Secondary
Part 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | 6.982 Hours | Geometric Coefficient of Variation 19.7 |
Secondary
Part 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | 0.000 Hours |
Secondary
Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dose
Population: PK parameter population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Dose 1 | 2.750 Hours |
| Part 1: Gepotidacin 1500 mg | Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval | Dose 2 | 1.500 Hours |