Infections, Bacterial
Conditions
Keywords
gepotidacin, GSK2140944, acute cystitis, pharmacokinetics, urinary tract infections
Brief summary
Gepotidacin (GSK2140944) is a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor that is being developed for the treatment of uncomplicated urinary tract infections (UTIs; acute cystitis). This Phase IIa study will evaluate plasma and urine pharmacokinetics of gepotidacin in female subjects with acute cystitis. Eligible female subjects will receive twice daily (BID) dose of gepotidacin 1500 milligram (mg) for 5 days via oral route. Pre-treatment and post-treatment samples for pharmacokinetic (PK) assessments will be collected throughout the study. The total duration of the study is approximately 28 days.
Interventions
DRUGGepotidacin
Gepotidacin tablets will be available at a dose strength of 750 mg. Tablets will be administered BID with water after consumption of food.
Sponsors
Biomedical Advanced Research and Development Authority
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will receive 1500 mg gepotidacin tablets BID via oral route for 5 days.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be \>=18 to \<=65 years of age inclusive, at the time of signing the informed consent. * The subject has 2 or more of the following clinical signs and symptoms of acute cystitis with onset \<=72 hours of the screening assessment: dysuria, frequency, urgency, or lower abdominal pain. * The subject has pyuria (\>=10 white blood cells per cubic millimeters \[WBC/mm\^3\] or the presence of leukocyte esterase) and/or nitrite from a pretreatment clean-catch midstream urine sample based on local laboratory procedures. * The subject is female. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a) Not a woman of childbearing potential (WOCBP) OR b) A WOCBP who agrees to follow the contraceptive guidance from the Baseline Visit through completion of the Test of Cure (TOC) Visit. * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and protocol.
Exclusion criteria
* The subject resides in a nursing home or dependent care-type facility. * The subject has a body mass index \>=40.0 kilogram per square meter (kg/m\^2) or a body mass index \>=35.0 kg/m\^2 with obesity-related health conditions such as high blood pressure or uncontrolled diabetes. * The subject has a history of sensitivity to the study treatment, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates her participation. * The subject is immunocompromised or has altered immune defenses that may predispose the subject to a higher risk of treatment failure and/or complications (e.g., renal transplant recipients, subjects with clinically significant persistent granulocytopenia \[absolute neutrophil count \<1000/microliter (µL)\], and subjects receiving immunosuppressive therapy, including corticosteroid therapy \[\>40 mg/day prednisolone or equivalent for \>1 week or \>=20 milligrams per day (mg/day) prednisolone or equivalent for \>6 weeks; or prednisolone or equivalent \>=10 mg/day for \>6 weeks\]). Subjects with a known cluster of differentiation 4 (CD4) count of \<200 cells/mm\^3 should not be enrolled. * The subject has uncontrolled diabetes, defined as a non-fasting glucose value \>300 milligrams per deciliter (mg/dL) or based on investigator judgment. * The subject has any of the following: A medical condition that requires medication that may be aggravated by inhibition of acetylcholinesterase, such as: a) Poorly controlled asthma or chronic obstructive pulmonary disease at Baseline and, in the opinion of the investigator, not stable on current therapy; b) Acute severe pain, uncontrolled with conventional medical management; c) Active peptic ulcer disease; d) Parkinson disease; e) Myasthenia gravis; f) A history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures) OR Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug (e.g., ileostomy or malabsorption syndrome). Subjects who have had a gastric bypass or a cholecystectomy are excluded from the study OR Hemoglobin value \<12 grams per deciliter (g/dL) or a known uncorrected iron deficiency. * The subject, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up. * The subject has a serious underlying disease that could be imminently life threatening, or the subject is unlikely to survive for the duration of the study period. * The subject has acute cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacteriaceae (other than Escherichia coli \[E. coli\]) as the contributing pathogen. * The subject has symptoms known or suspected to be caused by another disease process such as asymptomatic bacteriuria or chronic interstitial cystitis. * The subject has an anatomical or physiological anomaly that predisposes the subject to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder, or the subject has a history of anatomical or functional abnormalities of the urinary tract (e.g., chronic vesico-ureteral reflux, detrusor insufficiency). * The subject has an indwelling catheter, nephrostomy, ureter stent, or other foreign material in the urinary tract. * The subject who, in the opinion of the investigator, has an otherwise complicated UTI, an active upper UTI (e.g., pyelonephritis, urosepsis), signs and symptoms onset \>=96 hours before the Screening assessment, or a temperature \>=101 degree Fahrenheit, flank pain, chills, or any other manifestations suggestive of upper UTI. * The subject has anuria, oliguria, or significant impairment of renal function (creatinine clearance \<30 milliliters per minute \[mL/min\] or clinically significant elevated serum creatinine). * The subject presents with vaginal discharge at Baseline (e.g., suspected sexually transmitted disease). * The subject has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval. * The subject has uncompensated heart failure, defined as New York Heart Association Class \>=III. * The subject has severe left ventricular hypertrophy. * The subject has a family history of QT prolongation or sudden death. * The subject has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or bradyarrhythmia within the last 12 months. * The subject is taking QT-prolonging drugs or drugs known to increase the risk of torsades de points (TdP) per the www.crediblemeds.org Known Risk of TdP category at the time of her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the subject is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp) inhibitor. * The subject has a QT interval corrected for heart rate (QTc) \>450 milliseconds (msec) or a QTc \>480 msec for subjects with bundle-branch block. * The subject has a known ALT value \>2 times upper limit of normal (ULN). * The subject has a known bilirubin value \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * The subject has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C). * The subject has received treatment with other systemic antimicrobials or systemic antifungals within 1 week before study entry. * The subject must agree not to use the medications or nondrug therapies from the Baseline Visit through the TOC Visit. * The subject has been previously enrolled in this study or has previously been treated with gepotidacin. * The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population consisted of all participants who received gepotidacin 1500 mg BID through the completion of all PK collections for whom valid and evaluable plasma PK parameters were derived for gepotidacin. |
| Maximum Plasma Concentration (Cmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Time of Occurrence of Cmax (Tmax) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Apparent Steady State Clearance (CLss/F) of Gepotidacin | Day 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. CLss/F was calculated as Dose divided by AUC(0-tau). |
| Accumulation Ratio (Ro) of Gepotidacin | Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Accumulation ratio (Ro) was calculated as ratio of AUC(0-tau) at Day 4 to AUC(0-tau) at Day 1. |
| Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Days 1 to 5: Pre-dose | Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit) | Vital signs including SBP and DBP were measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Pulse Rate | Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit) | Vital sign including pulse rate was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Body Temperature | Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit) | Vital sign including body temperature was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | Baseline; Day 1: 2 hours; Day 4: pre-dose and 2 hours | A 12-lead ECG was measured in semi-supine position using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet counts. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Hematology Parameter: Hemoglobin | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Hematology Parameter: Hematocrit | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Volume. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Ae12hours was calculated by adding all the fractions of drug collected over all the allotted time intervals. |
| Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the chemistry parameters: ALT, AST and ALP. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Urine samples were collected at indicated time points to analyze parameters including glucose and nitrites by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative and positive in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented. |
| Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Urine samples were collected at indicated time points to analyze parameter including ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, 5 indicates 5 milligrams per deciliter (mg/dL) and 20 indicates 20 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented. |
| Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Urine samples were collected at indicated time points to analyze parameter including leukocyte esterase by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace indicates 15 Leukocytes per microliter (Leuko/mcL), Small indicates 70 Leuko/mcL, Moderate indicates 125 Leuko/mcL and Large indicates 500 Leuko/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented. |
| Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Urine samples were collected at indicated time points to analyze parameter including occult blood by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Small indicates 25 Erythrocytes per microliter (Ery/mcL), Moderate indicates 50 Ery/mcL and Large indicates 250 Ery/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented. |
| Number of Participants With Urinalysis Dipstick Results: Protein | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Urine samples were collected at indicated time points to analyze parameter including protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative indicates \<10 mg/dL, 1+ indicates 30 mg/dL and 2+ indicates 100 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented. |
| Number of Participants With Abnormal Physical Examination Findings | Up to Day 31 | Physical examinations included assessments of the respiratory, cardiovascular, abdominal, gastrointestinal, neurological and urogenital systems. This analysis was planned but data was not collected and captured in the database. |
| Change From Baseline in Hematology Parameter: Red Blood Cell Count | Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit) | Blood samples were collected to analyze the hematology parameter: Red blood cell count. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. |
| Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Ae(t1-t2) measure the amount of drug excreted in urine in a time intervals 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose on Days 1 and 4. The PK parameters were calculated by standard non-compartmental analysis. |
| Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. fe% was calculated as fe% = (Ae 12 hours/Dose) multiply by 100. The PK parameters were calculated by standard non-compartmental analysis. |
| Renal Clearance (CLr) of Gepotidacin | Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose | Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. CLr was calculated as CLr = Ae 12 hours/AUC(0-tau). The PK parameters were calculated by standard non-compartmental analysis. |
| Urine Pre-dose Concentration (Ctau) of Gepotidacin | Days 1 to 5: Pre-dose | Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs) | Up to Day 31 | An AEs is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as 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; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of gepotidacin. |
Countries
United States
Participant flow
Recruitment details
This was an open-label study to evaluate the pharmacokinetic (PK) of repeat oral doses of gepotidacin in adult female participants with clinical signs and symptoms of acute cystitis.
Pre-assignment details
A total of 22 participants were enrolled in this study. This study was conducted at a single center in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Gepotidacin 1500 mg All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Family emergency | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Gepotidacin 1500 mg |
|---|---|
| Age, Continuous | 37.1 Years STANDARD_DEVIATION 12.26 |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 18 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 21 / 22 |
| serious Total, serious adverse events | 1 / 22 |
Outcome results
Primary
Accumulation Ratio (Ro) of Gepotidacin
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Accumulation ratio (Ro) was calculated as ratio of AUC(0-tau) at Day 4 to AUC(0-tau) at Day 1.
Time frame: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Gepotidacin 1500 mg | Accumulation Ratio (Ro) of Gepotidacin | 1.402 Ratio | Geometric Coefficient of Variation 20.4 |
Primary
Apparent Steady State Clearance (CLss/F) of Gepotidacin
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. CLss/F was calculated as Dose divided by AUC(0-tau).
Time frame: Day 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose
Population: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Gepotidacin 1500 mg | Apparent Steady State Clearance (CLss/F) of Gepotidacin | 51.17 Liters per hour | Geometric Coefficient of Variation 31.8 |
Primary
Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population consisted of all participants who received gepotidacin 1500 mg BID through the completion of all PK collections for whom valid and evaluable plasma PK parameters were derived for gepotidacin.
Time frame: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Day 1, n=20 | 20236.2 Hours* nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 28.6 |
| Gepotidacin 1500 mg | Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin | Day 4, n=21 | 29313.8 Hours* nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 31.8 |
Primary
Maximum Plasma Concentration (Cmax) of Gepotidacin
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Maximum Plasma Concentration (Cmax) of Gepotidacin | Day 1, n=20 | 5891 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 47.3 |
| Gepotidacin 1500 mg | Maximum Plasma Concentration (Cmax) of Gepotidacin | Day 4, n=21 | 8437 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 38 |
Primary
Plasma Pre-dose Concentration (Ctau) of Gepotidacin
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 1 to 5: Pre-dose
Population: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Day 1, Pre-dose, n=22 | NA ng/mL | — |
| Gepotidacin 1500 mg | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Day 2, Pre-dose, n=21 | 620.5 ng/mL | Geometric Coefficient of Variation 62.3 |
| Gepotidacin 1500 mg | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Day 3, Pre-dose, n=21 | 789.3 ng/mL | Geometric Coefficient of Variation 37.4 |
| Gepotidacin 1500 mg | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Day 4, Pre-dose, n=21 | 851.4 ng/mL | Geometric Coefficient of Variation 41.4 |
| Gepotidacin 1500 mg | Plasma Pre-dose Concentration (Ctau) of Gepotidacin | Day 5, Pre-dose, n=21 | 818.9 ng/mL | Geometric Coefficient of Variation 46.4 |
Primary
Time of Occurrence of Cmax (Tmax) of Gepotidacin
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gepotidacin 1500 mg | Time of Occurrence of Cmax (Tmax) of Gepotidacin | Day 1, n=20 | 1.500 Hours |
| Gepotidacin 1500 mg | Time of Occurrence of Cmax (Tmax) of Gepotidacin | Day 4, n=21 | 1.917 Hours |
Secondary
Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Ae(t1-t2) measure the amount of drug excreted in urine in a time intervals 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose on Days 1 and 4. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 1, Ae (0-2),n=17 | NA mg | — |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 4, Ae (0-2),n=18 | 63.05 mg | Geometric Coefficient of Variation 151.7 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 1, Ae (2-4),n=17 | 131.9 mg | Geometric Coefficient of Variation 59.5 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 4, Ae (2-4),n=12 | 168.1 mg | Geometric Coefficient of Variation 96.5 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 1, Ae (4-6) ,n=14 | 87.01 mg | Geometric Coefficient of Variation 90 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 4, Ae (4-6),n=18 | 128.6 mg | Geometric Coefficient of Variation 96.8 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 1, Ae (6-8),n=16 | 54.60 mg | Geometric Coefficient of Variation 72.1 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 4, Ae (6-8),n=17 | 84.08 mg | Geometric Coefficient of Variation 92 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 1, Ae (8-10),n=9 | 18.51 mg | Geometric Coefficient of Variation 49.9 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 4, Ae (8-10),n=10 | 34.68 mg | Geometric Coefficient of Variation 69.2 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 1, Ae (10-12),n=14 | 18.03 mg | Geometric Coefficient of Variation 151.2 |
| Gepotidacin 1500 mg | Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin | Day 4, Ae (10-12),n=15 | 32.77 mg | Geometric Coefficient of Variation 83.5 |
Secondary
Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Ae12hours was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Time frame: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin | Day 1, n=20 | 298.7 mg | Geometric Coefficient of Variation 107.6 |
| Gepotidacin 1500 mg | Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin | Day 4, n=21 | 460.0 mg | Geometric Coefficient of Variation 55.8 |
Secondary
Change From Baseline in Body Temperature
Vital sign including body temperature was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Body Temperature | Day 2,n=22 | -0.05 Degree Celsius | Standard Deviation 0.246 |
| Gepotidacin 1500 mg | Change From Baseline in Body Temperature | Day 3,n=22 | -0.06 Degree Celsius | Standard Deviation 0.292 |
| Gepotidacin 1500 mg | Change From Baseline in Body Temperature | Day 4,n=21 | 0.02 Degree Celsius | Standard Deviation 0.405 |
| Gepotidacin 1500 mg | Change From Baseline in Body Temperature | Day 5,n=21 | -0.05 Degree Celsius | Standard Deviation 0.287 |
| Gepotidacin 1500 mg | Change From Baseline in Body Temperature | Days 10 to 13,n=20 | -0.10 Degree Celsius | Standard Deviation 0.27 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
Blood samples were collected to analyze the chemistry parameters: ALT, AST and ALP. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | ALT: Day 3, n=22 | -1.5 International units per liter | Standard Deviation 4.99 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | ALT: Day 5, n=21 | 1.7 International units per liter | Standard Deviation 7.51 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | ALT: Days 10 to 13, n=20 | 1.7 International units per liter | Standard Deviation 7.44 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | AST: Day 3, n=22 | -1.3 International units per liter | Standard Deviation 3.22 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | AST: Day 5, n=21 | 1.3 International units per liter | Standard Deviation 3.77 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | AST: Days 10 to 13, n=20 | 2.1 International units per liter | Standard Deviation 3.22 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | ALP: Day 3, n=22 | -3.3 International units per liter | Standard Deviation 7.91 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | ALP: Day 5, n=21 | -4.3 International units per liter | Standard Deviation 8.84 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP) | ALP: Days 10 to 13, n=20 | -4.5 International units per liter | Standard Deviation 7.76 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin: Day 3, n=22 | -2.0 Grams per liter | Standard Deviation 2.45 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin: Day 5, n=21 | -1.4 Grams per liter | Standard Deviation 2.71 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Albumin: Days 10 to 13, n=20 | -1.3 Grams per liter | Standard Deviation 2.9 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein: Day 3, n=22 | -3.0 Grams per liter | Standard Deviation 3.82 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein: Day 5, n=21 | -2.6 Grams per liter | Standard Deviation 4.52 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein | Protein: Days 10 to 13, n=20 | -2.4 Grams per liter | Standard Deviation 5.13 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin | Creatinine: Day 3, n=22 | 2.411 Micromoles per liter | Standard Deviation 9.9048 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin | Creatinine: Day 5, n=21 | 1.684 Micromoles per liter | Standard Deviation 7.7162 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin | Creatinine: Days 10 to 13, n=20 | 0.442 Micromoles per liter | Standard Deviation 7.2981 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin | Bilirubin: Day 3, n=14 | -1.8932 Micromoles per liter | Standard Deviation 4.06405 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin | Bilirubin: Day 5, n=15 | -1.6986 Micromoles per liter | Standard Deviation 3.41356 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin | Bilirubin: Days 10 to 13, n=14 | -1.6856 Micromoles per liter | Standard Deviation 3.42845 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 3, Glucose, n=22 | 0.13121 Millimoles per liter | Standard Deviation 1.237031 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 5, Glucose, n=21 | 0.87495 Millimoles per liter | Standard Deviation 1.382514 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Days 10 to 13, Glucose, n=20 | -0.05274 Millimoles per liter | Standard Deviation 0.498607 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 3, Calcium, n=22 | -0.05330 Millimoles per liter | Standard Deviation 0.075175 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 5, Calcium, n=21 | -0.05228 Millimoles per liter | Standard Deviation 0.093648 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Days 10 to 13, Calcium, n=20 | -0.07110 Millimoles per liter | Standard Deviation 0.095536 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 3, Chloride, n=22 | 0.5 Millimoles per liter | Standard Deviation 2.42 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 5, Chloride, n=21 | 0.3 Millimoles per liter | Standard Deviation 2.9 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Days 10 to 13, Chloride, n=20 | 0.3 Millimoles per liter | Standard Deviation 2.15 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 3, Potassium, n=22 | 0.04 Millimoles per liter | Standard Deviation 0.359 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 5, Potassium, n=21 | -0.05 Millimoles per liter | Standard Deviation 0.425 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Days 10 to 13, Potassium, n=20 | 0.01 Millimoles per liter | Standard Deviation 0.419 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 3, Sodium, n=22 | -0.7 Millimoles per liter | Standard Deviation 2.29 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 5, Sodium, n=21 | -1.6 Millimoles per liter | Standard Deviation 2.13 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Days 10 to 13, Sodium, n=20 | -0.9 Millimoles per liter | Standard Deviation 1.65 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 3, Urea, n=22 | 0.1298 Millimoles per liter | Standard Deviation 1.15836 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Day 5, Urea, n=21 | 0.0680 Millimoles per liter | Standard Deviation 1.06275 |
| Gepotidacin 1500 mg | Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea | Days 10 to 13, Urea, n=20 | 0.3927 Millimoles per liter | Standard Deviation 1.18063 |
Secondary
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
A 12-lead ECG was measured in semi-supine position using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Time frame: Baseline; Day 1: 2 hours; Day 4: pre-dose and 2 hours
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | PR interval, Day 1: 2 hours, n=22 | -1.9 Millisecond | Standard Deviation 11.34 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | PR interval, Day 4: pre-dose,n=21 | 0.1 Millisecond | Standard Deviation 14.56 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | PR interval, Day 4: 2 hours,n=21 | -3.5 Millisecond | Standard Deviation 10.17 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS duration, Day 1: 2 hours, n=22 | -0.7 Millisecond | Standard Deviation 8.32 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS duration, Day 4: pre-dose,n=21 | -0.9 Millisecond | Standard Deviation 4.1 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QRS duration, Day 4: 2 hours,n=21 | 2.1 Millisecond | Standard Deviation 4.29 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QT interval, Day 1: 2 hours, n=22 | 15.0 Millisecond | Standard Deviation 21.56 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QT interval, Day 4: pre-dose,n=21 | -5.4 Millisecond | Standard Deviation 26.86 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QT interval, Day 4: 2 hours,n=21 | 8.7 Millisecond | Standard Deviation 27.46 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB interval, Day 1: 2 hours, n=22 | 4.5 Millisecond | Standard Deviation 14.37 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB interval, Day 4: pre-dose,n=21 | -6.2 Millisecond | Standard Deviation 17.25 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcB interval, Day 4: 2 hours,n=21 | 0.4 Millisecond | Standard Deviation 27.33 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF interval, Day 1: 2 hours, n=22 | 8.2 Millisecond | Standard Deviation 14.45 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF interval, Day 4: pre-dose,n=21 | -5.8 Millisecond | Standard Deviation 17.57 |
| Gepotidacin 1500 mg | Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) | QTcF interval, Day 4: 2 hours,n=21 | 3.4 Millisecond | Standard Deviation 24.84 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin
Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin | Day 3, n=19 | 0.13 Picogram | Standard Deviation 0.564 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin | Day 5, n=18 | 0.03 Picogram | Standard Deviation 0.465 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin | Days 10 to 13, n=17 | 0.16 Picogram | Standard Deviation 0.348 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Volume. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Day 3, n=19 | 4.53 Femtoliter | Standard Deviation 5.814 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Day 5, n=18 | -0.72 Femtoliter | Standard Deviation 4.668 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume | Days 10 to 13, n=17 | 1.14 Femtoliter | Standard Deviation 6.252 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 3, n=19 | 0.75 Percentage of red blood cells in blood | Standard Deviation 3.186 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Hematocrit | Day 5, n=18 | -0.54 Percentage of red blood cells in blood | Standard Deviation 3.643 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Hematocrit | Days 10 to 13, n=17 | -2.30 Percentage of red blood cells in blood | Standard Deviation 2.956 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Hemoglobin | Day 3, n=19 | -3.4 Grams per liter | Standard Deviation 8.15 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Hemoglobin | Day 5, n=18 | -0.6 Grams per liter | Standard Deviation 9.34 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Hemoglobin | Days 10 to 13, n=17 | -8.2 Grams per liter | Standard Deviation 7.4 |
Secondary
Change From Baseline in Hematology Parameter: Red Blood Cell Count
Blood samples were collected to analyze the hematology parameter: Red blood cell count. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Red Blood Cell Count | Day 3, n=19 | -0.135 10^12 cells per liter | Standard Deviation 0.2574 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Red Blood Cell Count | Day 5, n=18 | -0.031 10^12 cells per liter | Standard Deviation 0.306 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameter: Red Blood Cell Count | Days 10 to 13, n=17 | -0.298 10^12 cells per liter | Standard Deviation 0.2552 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet counts. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Days 10 to 13, Monocytes, n=17 | -0.039 10^9 cells per liter | Standard Deviation 0.1415 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 3, Neutrophils, n=19 | -0.673 10^9 cells per liter | Standard Deviation 1.9611 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 3, Basophils, n=16 | 0.013 10^9 cells per liter | Standard Deviation 0.0652 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 5, Basophils, n=14 | -0.003 10^9 cells per liter | Standard Deviation 0.0164 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Days 10 to 13, Basophils, n=15 | 0.000 10^9 cells per liter | Standard Deviation 0.0146 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 3, Eosinophils, n=18 | 0.013 10^9 cells per liter | Standard Deviation 0.055 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 5, Eosinophils, n=17 | -0.003 10^9 cells per liter | Standard Deviation 0.0969 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Days 10 to 13, Eosinophils, n=16 | 0.051 10^9 cells per liter | Standard Deviation 0.0492 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 3, Lymphocytes, n=19 | 0.039 10^9 cells per liter | Standard Deviation 0.5201 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 5, Lymphocytes, n=18 | 0.041 10^9 cells per liter | Standard Deviation 0.4856 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Days 10 to 13, Lymphocytes, n=17 | 0.232 10^9 cells per liter | Standard Deviation 0.4001 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 3, Monocytes, n=19 | -0.053 10^9 cells per liter | Standard Deviation 0.108 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 5, Monocytes, n=18 | -0.069 10^9 cells per liter | Standard Deviation 0.1468 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 5, Neutrophils, n=18 | -0.948 10^9 cells per liter | Standard Deviation 2.3174 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Days 10 to 13, Neutrophils, n=17 | -0.841 10^9 cells per liter | Standard Deviation 1.4779 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 3, Platelet counts, n=19 | -3.6 10^9 cells per liter | Standard Deviation 22.94 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Day 5, Platelet counts, n=18 | 7.8 10^9 cells per liter | Standard Deviation 32.33 |
| Gepotidacin 1500 mg | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts | Days 10 to 13, Platelet counts, n=17 | 3.7 10^9 cells per liter | Standard Deviation 33.59 |
Secondary
Change From Baseline in Pulse Rate
Vital sign including pulse rate was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Pulse Rate | Day 2,n=22 | 2.2 Beats per minute | Standard Deviation 9.07 |
| Gepotidacin 1500 mg | Change From Baseline in Pulse Rate | Day 3,n=22 | 2.4 Beats per minute | Standard Deviation 10.24 |
| Gepotidacin 1500 mg | Change From Baseline in Pulse Rate | Day 4,n=21 | 2.9 Beats per minute | Standard Deviation 12.6 |
| Gepotidacin 1500 mg | Change From Baseline in Pulse Rate | Day 5,n=21 | 7.2 Beats per minute | Standard Deviation 9.5 |
| Gepotidacin 1500 mg | Change From Baseline in Pulse Rate | Days 10 to 13,n=20 | 0.8 Beats per minute | Standard Deviation 12.38 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital signs including SBP and DBP were measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Time frame: Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 2,n=22 | -3.1 Millimeters of mercury | Standard Deviation 16.13 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 3,n=22 | -0.3 Millimeters of mercury | Standard Deviation 15.74 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 4,n=21 | -1.5 Millimeters of mercury | Standard Deviation 13.1 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Day 5,n=21 | 0.9 Millimeters of mercury | Standard Deviation 15.46 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Days 10 to 13,n=20 | 1.5 Millimeters of mercury | Standard Deviation 14.21 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 2,n=22 | -2.3 Millimeters of mercury | Standard Deviation 9.32 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 3,n=22 | -1.1 Millimeters of mercury | Standard Deviation 11.64 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 4,n=21 | 0.5 Millimeters of mercury | Standard Deviation 9.65 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Day 5,n=21 | 4.7 Millimeters of mercury | Standard Deviation 7.23 |
| Gepotidacin 1500 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Days 10 to 13,n=20 | 2.7 Millimeters of mercury | Standard Deviation 8.77 |
Secondary
Number of Participants With Abnormal Physical Examination Findings
Physical examinations included assessments of the respiratory, cardiovascular, abdominal, gastrointestinal, neurological and urogenital systems. This analysis was planned but data was not collected and captured in the database.
Time frame: Up to Day 31
Population: Safety Population. This analysis was planned but data was not collected and captured in the database.
Secondary
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs)
An AEs is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as 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; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
Time frame: Up to Day 31
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 1500 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs) | Non-SAEs | 21 Participants |
| Gepotidacin 1500 mg | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs) | SAEs | 1 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Urine samples were collected at indicated time points to analyze parameters including glucose and nitrites by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative and positive in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Baseline:Glucose,Negative,n=22 | 22 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Day 3:Glucose,Negative,n=22 | 22 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Day 5:Glucose,Negative,n=21 | 21 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Days 10 to 13:Glucose,Negative,n=20 | 20 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Baseline: Nitrites,Negative,n=22 | 13 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Baseline: Nitrites,Positive,n=22 | 9 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Day 3: Nitrites,Negative,n=22 | 22 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Day 5: Nitrites,Negative,n=21 | 21 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites | Days 10 to 13: Nitrites,Negative,n=20 | 20 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results: Ketones
Urine samples were collected at indicated time points to analyze parameter including ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, 5 indicates 5 milligrams per deciliter (mg/dL) and 20 indicates 20 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline:Ketones,Negative,n=22 | 21 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Ketones | Baseline:Ketones,20,n=22 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Ketones | Day 3:Ketones,Negative,n=22 | 22 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Ketones | Day 5:Ketones,Negative,n=21 | 21 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Ketones | Days 10 to 13:Ketones,Negative,n=20 | 18 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Ketones | Days 10 to 13:Ketones,5,n=20 | 2 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Urine samples were collected at indicated time points to analyze parameter including leukocyte esterase by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace indicates 15 Leukocytes per microliter (Leuko/mcL), Small indicates 70 Leuko/mcL, Moderate indicates 125 Leuko/mcL and Large indicates 500 Leuko/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline:Leukocyte esterase,Negative,n=22 | 4 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline:Leukocyte esterase,Trace,n=22 | 2 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline:Leukocyte esterase,Small,n=22 | 4 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline:Leukocyte esterase,Moderate,n=22 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Baseline:Leukocyte esterase,Large,n=22 | 11 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 3:Leukocyte esterase,Negative,n=22 | 19 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 3:Leukocyte esterase,Small,n=22 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 3:Leukocyte esterase,Moderate,n=22 | 2 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5:Leukocyte esterase,Negative,n=21 | 16 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5:Leukocyte esterase,Trace,n=21 | 4 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Day 5:Leukocyte esterase,Small,n=21 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Days 10 to 13:Leukocyte esterase,Negative,n=20 | 19 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase | Days 10 to 13:Leukocyte esterase,Trace,n=20 | 1 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Urine samples were collected at indicated time points to analyze parameter including occult blood by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Small indicates 25 Erythrocytes per microliter (Ery/mcL), Moderate indicates 50 Ery/mcL and Large indicates 250 Ery/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline:Occult blood,Negative,n=22 | 6 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline:Occult blood,Small,n=22 | 10 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline:Occult blood,Moderate,n=22 | 3 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Baseline:Occult blood,Large,n=22 | 3 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 3:Occult blood,Negative,n=22 | 19 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 3:Occult blood,Small,n=22 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 3:Occult blood,Moderate,n=22 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 3:Occult blood,Large,n=22 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5:Occult blood,Negative,n=21 | 17 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5:Occult blood,Small,n=21 | 2 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Day 5:Occult blood,Moderate,n=21 | 2 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Days 10 to 13:Occult blood,Negative,n=20 | 18 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Occult Blood | Days 10 to 13:Occult blood,Small,n=20 | 2 Participants |
Secondary
Number of Participants With Urinalysis Dipstick Results: Protein
Urine samples were collected at indicated time points to analyze parameter including protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative indicates \<10 mg/dL, 1+ indicates 30 mg/dL and 2+ indicates 100 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Time frame: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)
Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Days 10 to 13: Protein,1+,n=20 | 2 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Baseline: Protein,Negative,n=22 | 11 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Baseline: Protein,1+,n=22 | 10 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Baseline: Protein,2+,n=22 | 1 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Day 3: Protein,Negative,n=22 | 18 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Day 3: Protein,1+,n=22 | 4 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Day 5: Protein,Negative,n=21 | 16 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Day 5: Protein,1+,n=21 | 5 Participants |
| Gepotidacin 1500 mg | Number of Participants With Urinalysis Dipstick Results: Protein | Days 10 to 13: Protein,Negative,n=20 | 18 Participants |
Secondary
Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. fe% was calculated as fe% = (Ae 12 hours/Dose) multiply by 100. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Day 1, n=20 | 19.91 Percentage of dose | Geometric Coefficient of Variation 107.6 |
| Gepotidacin 1500 mg | Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin | Day 4, n=21 | 30.67 Percentage of dose | Geometric Coefficient of Variation 55.8 |
Secondary
Renal Clearance (CLr) of Gepotidacin
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. CLr was calculated as CLr = Ae 12 hours/AUC(0-tau). The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Renal Clearance (CLr) of Gepotidacin | Day 1, n=20 | 14.76 Liters per hour | Geometric Coefficient of Variation 118.2 |
| Gepotidacin 1500 mg | Renal Clearance (CLr) of Gepotidacin | Day 4, n=21 | 15.69 Liters per hour | Geometric Coefficient of Variation 45.2 |
Secondary
Urine Pre-dose Concentration (Ctau) of Gepotidacin
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: Days 1 to 5: Pre-dose
Population: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Gepotidacin 1500 mg | Urine Pre-dose Concentration (Ctau) of Gepotidacin | Day 1, Pre-dose, n=21 | NA Micrograms per milliliter | — |
| Gepotidacin 1500 mg | Urine Pre-dose Concentration (Ctau) of Gepotidacin | Day 2, Pre-dose, n=20 | 279.1 Micrograms per milliliter | Geometric Coefficient of Variation 154.7 |
| Gepotidacin 1500 mg | Urine Pre-dose Concentration (Ctau) of Gepotidacin | Day 3, Pre-dose, n=21 | 322.2 Micrograms per milliliter | Geometric Coefficient of Variation 138.8 |
| Gepotidacin 1500 mg | Urine Pre-dose Concentration (Ctau) of Gepotidacin | Day 4, Pre-dose, n=21 | 326.7 Micrograms per milliliter | Geometric Coefficient of Variation 248.7 |
| Gepotidacin 1500 mg | Urine Pre-dose Concentration (Ctau) of Gepotidacin | Day 5, Pre-dose, n=21 | 351.7 Micrograms per milliliter | Geometric Coefficient of Variation 146.5 |