To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

A Phase I; Multi-Center; Open-Label (Parts 1 and 2); Randomized, Double-Blind, Placebo-Controlled (Part 3); Single-Dose; 3-Part Study to Evaluate the Relative Bioavailability of Three Formulations in Healthy Subjects, Food Effect on Tablet Formulation in Healthy Subjects, and Pharmacokinetics of Gepotidacin (GSK2140944) in Japanese Subjects in Fasted and Fed States

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02853435

Enrollment

Registered

2016-08-03

Start date

2016-08-04

Completion date

2017-10-17

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Bacterial

Keywords

Cross-over, Gepotidacin, Pharmacokinetics, Relative Bioavailability, non-compartmental PK analysis, High shear wet granulation

Brief summary

This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted \[RC\] and high shear wet granulation \[HSWG\]) compared to the reference capsule formulation under fasted conditions. This is a 3-period; cross-over study that will guide which gepotidacin formulation will be used for future studies. Following review of pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed with Parts 1b and 2. Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will be evaluated under fasted conditions. The duration of the study (from Screening to the Follow-up visit) will be approximately 44 days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3 treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12 Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.

Interventions

DRUGGepotidacin RC Tablet

The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.

DRUGGepotidacin HSWG Tablet

The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.

DRUGGepotidacin Capsule

It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female subjects between 18 and 64 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator based on medical history, clinical laboratory results (serum chemistry, hematology, urinalysis, and serology), vital sign measurements, 12-lead ECG results, and physical examination findings. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Additional inclusion criteria for Japanese subjects (Part 2a only): the subject was a non-naturalized Japanese citizen and held a Japanese passport, the subject had 2 Japanese parents and 4 Japanese grandparents who were all non naturalized Japanese citizens, as confirmed by interview and the subject had been living outside of Japan for up to 10 years as confirmed by interview. * Additional inclusion criteria for Chinese subjects (Part 2b only): the subject was a non-naturalized Chinese citizen and held a Chinese passport, the subject had 2 Chinese parents and 4 Chinese grandparents who were all non naturalized Chinese citizens, as confirmed by interview, the subject had been living outside of China for up to 10 years as confirmed by interview. * Body weight for subjects in Part 1a and 1b: more than equal to (\>=) 50 kilogram (kg) and body mass index (BMI) within the range 19 and 32 kilogram per meter square (kg/m\^2), inclusive and for Japanese and Chinese subjects (Part 2a and 2b): \>=50 kg and BMI within the range 18 and 32 kg/m\^2, inclusive. * Male or female: a female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin test, not lactating, and at least one of the following conditions applies. Non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral oophorectomy and postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle-stimulating hormone and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential from 30 days prior to the first dose of study medication and until completion of the Follow-up visit. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion criteria

* Subject has a clinically significant abnormality in 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, respiratory, hematologic, or immunologic disease. * Subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk, in the opinion of the investigator. * QTc more than (\>) 450 millisecond (msec). * Use of a 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 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 sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic uses heparin to maintain intravenous cannula patency). * Subjects cannot use any over-the-counter, or prescription medication (except for hormonal contraceptives and/or acetaminophen), vitamin supplement, or herbal medication within 7 days (or 5 half-lives, whichever is longer) before dosing and during the study. * 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 milliliter (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. * History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. * Presence of hepatitis B surface antigen, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. * Female subject has a positive pregnancy test result or is lactating at Screening or upon admission to the clinic. * 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 less than \[\<\] 35 percent \[%\]). * Urinalysis positive for blood without other cause identified. * A positive pre-study drug/alcohol screen. * A positive test for human immunodeficiency virus antibody. * Subject has clinically significant abnormal findings in serum chemistry, hematology, or urinalysis results obtained at Screening or Day -1. * Donation of 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. * Previous exposure to gepotidacin within 12 months prior to the first dosing day. *

Design outcomes

Primary

Secondary

Measure	Time frame	Description
Change From Baseline in ECG Parameter Heart Rate for Part 2	Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 2. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Baseline and up to 11 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 4+ 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 2. Only categories with significant values have been presented.
Number of Participants With Non-serious AEs and SAEs for Part 3	Up to 14 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin and serum creatinine for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a	Up to 14 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Participants with non-serious AEs and SAEs has been reported. Safety Population comprised of all participants who received at least 1 dose of study medication and had at least 1 post dose safety assessment.
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in ECG Parameter Heart Rate for Part 3	Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 3. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Up to 14 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 3. Only categories with significant values have been presented.
Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Ery. for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a	Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Change From Baseline in 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) for Part 1a	Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1a. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Up to 14 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 1a. Only categories with significant values have been presented.
Number of Participants With AEs and SAEs for Part 1b	Up to 11 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum albuim and serum protein for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin in Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Ery. for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1b	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 1b	Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in Vital Sign Parameter Heart Rate for Part 1b	Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in ECG Parameter Heart Rate for Part 1b	Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 1b	Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1b. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1b	Up to 11 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.
Number of Participants With Non-serious AEs and SAEs for Part 2	Up to 11 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameter namely serum estradiol for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the indicated time point were analyzed. NA indicates standard deviation was not calculated as a single participant was analyzed.
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Hematology Parameter Blood Ery. for Part 2	Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.
Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Countries

United States

Participant flow

Recruitment details

This study was conducted across 2 centers in the United States from 04-August-2016 to 18-October-2017. Since the relative bio-availability of the roller compacted(RC) tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Pre-assignment details

A total of 48 participants were enrolled in the study of which 26 participants were randomized in Part 1a, 10 participants were randomized in Part 2 and 12 participants were part of Placebo-controlled Part 3.

Participants by arm

Arm	Count
Total Participants-Part 1a Participants received gepotidacin 1500 mg (3 x 500 mg) capsules, gepotidacin 1500 mg (2 x 750 mg) RC tablets and gepotidacin 1500 mg (2 x 750 mg) HSWG tablets orally in one of the 3 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.	26
Total Participants-Part 2 Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets and gepotidacin 3000 mg (4 x 750 mg) RC tablets orally in one of the 2 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.	10
Total Participants- Part 3 Participants received gepotidacin 1500 mg (2 x 750 mg) RC tablets - fed, gepotidacin 2250 mg (3 x 750 mg) RC tablets - fed and gepotidacin 3000 mg (4 x 750 mg) RC tablets - fed orally in one of the 3 treatment periods in a cross-over manner. There was a washout period of at least 3 days between the doses.	12
Total	48

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Part 3, Washout Period 2 (3 Days)	Withdrawal by Subject	0	0	0	0	1	0

Baseline characteristics

Characteristic	Total	Total Participants-Part 1a	Total Participants-Part 2	Total Participants- Part 3
Age, Continuous	42.5 Years STANDARD_DEVIATION 11.39	39.5 Years STANDARD_DEVIATION 10.64	55.6 Years STANDARD_DEVIATION 6.43	37.8 Years STANDARD_DEVIATION 7.93
Race/Ethnicity, Customized Asian - Japanese Heritage	22 Participants	0 Participants	10 Participants	12 Participants
Race/Ethnicity, Customized Black or African American	10 Participants	10 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	16 Participants	16 Participants	0 Participants	0 Participants
Sex: Female, Male Female	19 Participants	5 Participants	8 Participants	6 Participants
Sex: Female, Male Male	29 Participants	21 Participants	2 Participants	6 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 26	0 / 26	0 / 10	0 / 10	0 / 10	0 / 10	0 / 9	0 / 2
other Total, other adverse events	8 / 26	5 / 26	9 / 26	6 / 10	9 / 10	0 / 10	1 / 10	6 / 9	0 / 2
serious Total, serious adverse events	0 / 26	0 / 26	0 / 26	0 / 10	0 / 10	0 / 10	0 / 10	0 / 9	0 / 2

Outcome results

Primary

Ae (t1-t2) for Part 2

PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (0-2)	50.893 milligrams	Geometric Coefficient of Variation 289.7
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (2-4)	47.995 milligrams	Geometric Coefficient of Variation 42.7
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (4-6)	21.381 milligrams	Geometric Coefficient of Variation 47.5
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (6-8)	11.759 milligrams	Geometric Coefficient of Variation 88.2
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (8-12)	12.519 milligrams	Geometric Coefficient of Variation 104.6
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (12-24)	9.810 milligrams	Geometric Coefficient of Variation 226.4
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (24-36)	3.710 milligrams	Geometric Coefficient of Variation 111
Gepotidacin 1500 mg - R Capsules	Ae (t1-t2) for Part 2	Ae (36-48)	2.743 milligrams	Geometric Coefficient of Variation 114.7
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (36-48)	3.652 milligrams	Geometric Coefficient of Variation 136.1
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (0-2)	115.793 milligrams	Geometric Coefficient of Variation 73
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (8-12)	29.474 milligrams	Geometric Coefficient of Variation 96
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (2-4)	131.013 milligrams	Geometric Coefficient of Variation 92.1
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (24-36)	9.754 milligrams	Geometric Coefficient of Variation 51
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (4-6)	97.651 milligrams	Geometric Coefficient of Variation 139.4
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (12-24)	30.849 milligrams	Geometric Coefficient of Variation 83.9
Gepotidacin 1500 mg RC Tablets	Ae (t1-t2) for Part 2	Ae (6-8)	40.670 milligrams	Geometric Coefficient of Variation 36.2

Primary

Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Population: PK Parameter Population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (0-2), n=26,25,26	65.817 milligrams	Geometric Coefficient of Variation 95.1
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (2-4),n=26,24,25	72.734 milligrams	Geometric Coefficient of Variation 67.3
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (4-6),n=25,25,26	36.019 milligrams	Geometric Coefficient of Variation 44.2
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (6-8),n=25,26,26	22.817 milligrams	Geometric Coefficient of Variation 37.4
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (8-12),n=26,26,26	21.515 milligrams	Geometric Coefficient of Variation 57.3
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (12-24),n=26,26,26	19.224 milligrams	Geometric Coefficient of Variation 60.4
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (24-36),n=26,26,26	8.145 milligrams	Geometric Coefficient of Variation 35
Gepotidacin 1500 mg - R Capsules	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (36-48),n=26,26,26	4.633 milligrams	Geometric Coefficient of Variation 31.4
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (4-6),n=25,25,26	45.313 milligrams	Geometric Coefficient of Variation 61.1
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (24-36),n=26,26,26	9.787 milligrams	Geometric Coefficient of Variation 27.8
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (6-8),n=25,26,26	26.061 milligrams	Geometric Coefficient of Variation 24.9
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (8-12),n=26,26,26	25.609 milligrams	Geometric Coefficient of Variation 27.7
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (12-24),n=26,26,26	22.536 milligrams	Geometric Coefficient of Variation 26.9
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (0-2), n=26,25,26	60.915 milligrams	Geometric Coefficient of Variation 102.9
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (2-4),n=26,24,25	77.650 milligrams	Geometric Coefficient of Variation 33.6
Gepotidacin 1500 mg RC Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (36-48),n=26,26,26	4.517 milligrams	Geometric Coefficient of Variation 57.7
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (4-6),n=25,25,26	39.361 milligrams	Geometric Coefficient of Variation 39.1
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (2-4),n=26,24,25	67.419 milligrams	Geometric Coefficient of Variation 72
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (0-2), n=26,25,26	85.584 milligrams	Geometric Coefficient of Variation 67.7
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (6-8),n=25,26,26	22.755 milligrams	Geometric Coefficient of Variation 28.7
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (24-36),n=26,26,26	8.185 milligrams	Geometric Coefficient of Variation 44.4
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (12-24),n=26,26,26	19.432 milligrams	Geometric Coefficient of Variation 32.9
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (8-12),n=26,26,26	16.590 milligrams	Geometric Coefficient of Variation 75.5
Gepotidacin 1500 mg HSWG Tablets	Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a	Ae (36-48),n=26,26,26	4.319 milligrams	Geometric Coefficient of Variation 41

Primary

Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a

Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a	16409 hours*nanograms/milliliters	Geometric Coefficient of Variation 26.2
Gepotidacin 1500 mg RC Tablets	Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a	17125 hours*nanograms/milliliters	Geometric Coefficient of Variation 23.4
Gepotidacin 1500 mg HSWG Tablets	Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a	18317 hours*nanograms/milliliters	Geometric Coefficient of Variation 24.1

90% CI: [0.9792, 1.1062]

90% CI: [1.0479, 1.1838]

Primary

Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a

Blood samples for pharmacokinetic (PK) analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 milliliters (mL) of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. The PK Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. Statistics has been presented on geometric least square (LS) means.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a	16733 hours*nanograms/milliliter	Geometric Coefficient of Variation 25.7
Gepotidacin 1500 mg RC Tablets	Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a	17495 hours*nanograms/milliliter	Geometric Coefficient of Variation 23
Gepotidacin 1500 mg HSWG Tablets	Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a	18646 hours*nanograms/milliliter	Geometric Coefficient of Variation 24

90% CI: [0.9809, 1.1063]

90% CI: [1.0459, 1.1797]

Primary

Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a	1904 micrograms*hours/milliliter	Geometric Coefficient of Variation 82.7
Gepotidacin 1500 mg RC Tablets	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a	1948 micrograms*hours/milliliter	Geometric Coefficient of Variation 61.2
Gepotidacin 1500 mg HSWG Tablets	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a	2156 micrograms*hours/milliliter	Geometric Coefficient of Variation 74.8

Primary

Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a	2373 micrograms*hours/milliliter	Geometric Coefficient of Variation 74.9
Gepotidacin 1500 mg RC Tablets	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a	2464 micrograms*hours/milliliter	Geometric Coefficient of Variation 56.3
Gepotidacin 1500 mg HSWG Tablets	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a	2599 micrograms*hours/milliliter	Geometric Coefficient of Variation 69

Primary

Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Population: PK Parameter Population.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a	2597 micrograms*hours/milliliter	Geometric Coefficient of Variation 69.5
Gepotidacin 1500 mg RC Tablets	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a	2725 micrograms*hours/milliliter	Geometric Coefficient of Variation 54.4
Gepotidacin 1500 mg HSWG Tablets	Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a	2768 micrograms*hours/milliliter	Geometric Coefficient of Variation 64

Primary

AUC (0-12) for Part 2

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	AUC (0-12) for Part 2	1298 micrograms*hours/milliliter	Geometric Coefficient of Variation 110.8
Gepotidacin 1500 mg RC Tablets	AUC (0-12) for Part 2	4758 micrograms*hours/milliliter	Geometric Coefficient of Variation 64.6

Primary

AUC (0-24) for Part 2

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	AUC (0-24) for Part 2	1714 micrograms*hours/milliliter	Geometric Coefficient of Variation 88.8
Gepotidacin 1500 mg RC Tablets	AUC (0-24) for Part 2	5594 micrograms*hours/milliliter	Geometric Coefficient of Variation 61.9

Primary

AUC (0-48) for Part 2

PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	AUC (0-48) for Part 2	1875 micrograms*hours/milliliter	Geometric Coefficient of Variation 83.6
Gepotidacin 1500 mg RC Tablets	AUC (0-48) for Part 2	5845 micrograms*hours/milliliter	Geometric Coefficient of Variation 61.1

Primary

AUC (0-infinity) of Plasma Gepotidacin for Part 1b

Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Primary

AUC (0-infinity) of Plasma Gepotidacin for Part 2

Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	AUC (0-infinity) of Plasma Gepotidacin for Part 2	23137 hours*nanograms/milliliter	Geometric Coefficient of Variation 34.1
Gepotidacin 1500 mg RC Tablets	AUC (0-infinity) of Plasma Gepotidacin for Part 2	46537 hours*nanograms/milliliter	Geometric Coefficient of Variation 20.9

Primary

AUC (0-infinity) of Plasma Gepotidacin for Part 3

Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	AUC (0-infinity) of Plasma Gepotidacin for Part 3	22921 hours*nanograms/milliliter	Geometric Coefficient of Variation 19.9
Gepotidacin 1500 mg RC Tablets	AUC (0-infinity) of Plasma Gepotidacin for Part 3	37235 hours*nanograms/milliliter	Geometric Coefficient of Variation 17.2
Gepotidacin 1500 mg HSWG Tablets	AUC (0-infinity) of Plasma Gepotidacin for Part 3	50178 hours*nanograms/milliliter	Geometric Coefficient of Variation 21.9

Primary

AUC (0-t) of Plasma Gepotidacin for Part 1b

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Primary

AUC (0-t) of Plasma Gepotidacin for Part 2

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	AUC (0-t) of Plasma Gepotidacin for Part 2	22777 hours*nanograms/milliliter	Geometric Coefficient of Variation 34.4
Gepotidacin 1500 mg RC Tablets	AUC (0-t) of Plasma Gepotidacin for Part 2	46120 hours*nanograms/milliliter	Geometric Coefficient of Variation 21.1

Primary

AUC (0-t) of Plasma Gepotidacin for Part 3

Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	AUC (0-t) of Plasma Gepotidacin for Part 3	22709 hours*nanograms/milliliter	Geometric Coefficient of Variation 20
Gepotidacin 1500 mg RC Tablets	AUC (0-t) of Plasma Gepotidacin for Part 3	36938 hours*nanograms/milliliter	Geometric Coefficient of Variation 17.2
Gepotidacin 1500 mg HSWG Tablets	AUC (0-t) of Plasma Gepotidacin for Part 3	49789 hours*nanograms/milliliter	Geometric Coefficient of Variation 21.7

Primary

CLr for Part 2

PK urine samples were collected at pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	CLr for Part 2	8.950 liters/hour	Geometric Coefficient of Variation 41.5
Gepotidacin 1500 mg RC Tablets	CLr for Part 2	11.834 liters/hour	Geometric Coefficient of Variation 32

Primary

CLr for Part 3

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	CLr for Part 3	17.196 liters/hour	Geometric Coefficient of Variation 24.8
Gepotidacin 1500 mg RC Tablets	CLr for Part 3	16.598 liters/hour	Geometric Coefficient of Variation 26.5
Gepotidacin 1500 mg HSWG Tablets	CLr for Part 3	17.969 liters/hour	Geometric Coefficient of Variation 21.2

Primary

Cmax of Plasma Gepotidacin for Part 1b

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Primary

Cmax of Plasma Gepotidacin for Part 2

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Cmax of Plasma Gepotidacin for Part 2	9177 nanograms/milliliter	Geometric Coefficient of Variation 94.8
Gepotidacin 1500 mg RC Tablets	Cmax of Plasma Gepotidacin for Part 2	15335 nanograms/milliliter	Geometric Coefficient of Variation 28.6

Primary

Cmax of Plasma Gepotidacin for Part 3

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Cmax of Plasma Gepotidacin for Part 3	6502 nanograms/milliliter	Geometric Coefficient of Variation 27.7
Gepotidacin 1500 mg RC Tablets	Cmax of Plasma Gepotidacin for Part 3	9812 nanograms/milliliter	Geometric Coefficient of Variation 21.1
Gepotidacin 1500 mg HSWG Tablets	Cmax of Plasma Gepotidacin for Part 3	12889 nanograms/milliliter	Geometric Coefficient of Variation 21.1

Primary

fe% for Part 2

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	fe% for Part 2	13.591 Percentage dose of drug excreted	Geometric Coefficient of Variation 38.8
Gepotidacin 1500 mg RC Tablets	fe% for Part 2	18.207 Percentage dose of drug excreted	Geometric Coefficient of Variation 51.8

Primary

fe% for Part 3

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	fe% for Part 3	26.008 Percentage dose of drug excreted	Geometric Coefficient of Variation 34.3
Gepotidacin 1500 mg RC Tablets	fe% for Part 3	27.273 Percentage dose of drug excreted	Geometric Coefficient of Variation 32.2
Gepotidacin 1500 mg HSWG Tablets	fe% for Part 3	29.858 Percentage dose of drug excreted	Geometric Coefficient of Variation 27.8

Primary

Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (MEDIAN)
Gepotidacin 1500 mg - R Capsules	Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a	0.00 hours
Gepotidacin 1500 mg RC Tablets	Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a	0.00 hours
Gepotidacin 1500 mg HSWG Tablets	Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a	0.00 hours

Primary

Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a	4648 nanograms/milliliter	Geometric Coefficient of Variation 43.8
Gepotidacin 1500 mg RC Tablets	Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a	4487 nanograms/milliliter	Geometric Coefficient of Variation 43.6
Gepotidacin 1500 mg HSWG Tablets	Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a	5349 nanograms/milliliter	Geometric Coefficient of Variation 46.8

90% CI: [0.844, 1.0888]

90% CI: [1.0113, 1.3047]

Primary

Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a	18.329 Percentage dose of drug excreted	Geometric Coefficient of Variation 28.6
Gepotidacin 1500 mg RC Tablets	Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a	19.116 Percentage dose of drug excreted	Geometric Coefficient of Variation 22.2
Gepotidacin 1500 mg HSWG Tablets	Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a	18.968 Percentage dose of drug excreted	Geometric Coefficient of Variation 30

Primary

Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a

Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. NA indicates data was not available as this was the reference capsule the Frel of each tablet type was being compared to.

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a	NA Ratio of AUC (0-infinity)	—
Gepotidacin 1500 mg RC Tablets	Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a	1.05 Ratio of AUC (0-infinity)	Geometric Coefficient of Variation 22.3
Gepotidacin 1500 mg HSWG Tablets	Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a	1.11 Ratio of AUC (0-infinity)	Geometric Coefficient of Variation 16.5

Primary

Renal Clearance of Drug in Urine (CLr) for Part 1a

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Renal Clearance of Drug in Urine (CLr) for Part 1a	16.761 liters/hour	Geometric Coefficient of Variation 21.7
Gepotidacin 1500 mg RC Tablets	Renal Clearance of Drug in Urine (CLr) for Part 1a	16.740 liters/hour	Geometric Coefficient of Variation 19.6
Gepotidacin 1500 mg HSWG Tablets	Renal Clearance of Drug in Urine (CLr) for Part 1a	15.532 liters/hour	Geometric Coefficient of Variation 22.3

Primary

t1/2 of Plasma Gepotidacin for Part 1b

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Primary

t1/2 of Plasma Gepotidacin for Part 2

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	t1/2 of Plasma Gepotidacin for Part 2	10.73 hours	Geometric Coefficient of Variation 10.9
Gepotidacin 1500 mg RC Tablets	t1/2 of Plasma Gepotidacin for Part 2	8.81 hours	Geometric Coefficient of Variation 8.4

Primary

t1/2 of Plasma Gepotidacin for Part 3

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	t1/2 of Plasma Gepotidacin for Part 3	9.23 hours	Geometric Coefficient of Variation 9.7
Gepotidacin 1500 mg RC Tablets	t1/2 of Plasma Gepotidacin for Part 3	8.19 hours	Geometric Coefficient of Variation 7.2
Gepotidacin 1500 mg HSWG Tablets	t1/2 of Plasma Gepotidacin for Part 3	7.93 hours	Geometric Coefficient of Variation 10.6

Primary

Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a	10.29 hours	Geometric Coefficient of Variation 13.7
Gepotidacin 1500 mg RC Tablets	Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a	10.24 hours	Geometric Coefficient of Variation 15.2
Gepotidacin 1500 mg HSWG Tablets	Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a	10.24 hours	Geometric Coefficient of Variation 12.1

Primary

Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (MEDIAN)
Gepotidacin 1500 mg - R Capsules	Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a	1.50 hours
Gepotidacin 1500 mg RC Tablets	Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a	1.50 hours
Gepotidacin 1500 mg HSWG Tablets	Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a	1.00 hours

p-value: 0.30990% CI: [-0.267, 0]Wilcoxon signed-rank test.

p-value: <0.00190% CI: [-0.5, -0.25]Wilcoxon signed-rank test.

Primary

Tlag of Plasma Gepotidacin for Part 1b

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Primary

Tlag of Plasma Gepotidacin for Part 2

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (MEDIAN)
Gepotidacin 1500 mg - R Capsules	Tlag of Plasma Gepotidacin for Part 2	0.00 hours
Gepotidacin 1500 mg RC Tablets	Tlag of Plasma Gepotidacin for Part 2	0.00 hours

Primary

Tlag of Plasma Gepotidacin for Part 3

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (MEDIAN)
Gepotidacin 1500 mg - R Capsules	Tlag of Plasma Gepotidacin for Part 3	0.50 hours
Gepotidacin 1500 mg RC Tablets	Tlag of Plasma Gepotidacin for Part 3	0.00 hours
Gepotidacin 1500 mg HSWG Tablets	Tlag of Plasma Gepotidacin for Part 3	0.00 hours

Primary

Tmax of Plasma Gepotidacin for Part 1b

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Primary

Tmax of Plasma Gepotidacin for Part 2

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (MEDIAN)
Gepotidacin 1500 mg - R Capsules	Tmax of Plasma Gepotidacin for Part 2	1.00 hours
Gepotidacin 1500 mg RC Tablets	Tmax of Plasma Gepotidacin for Part 2	0.56 hours

Primary

Tmax of Plasma Gepotidacin for Part 3

Time frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period

Population: PK Parameter Population

Arm	Measure	Value (MEDIAN)
Gepotidacin 1500 mg - R Capsules	Tmax of Plasma Gepotidacin for Part 3	2.25 hours
Gepotidacin 1500 mg RC Tablets	Tmax of Plasma Gepotidacin for Part 3	2.05 hours
Gepotidacin 1500 mg HSWG Tablets	Tmax of Plasma Gepotidacin for Part 3	2.00 hours

Primary

Total Unchanged Drug (Ae Total) for Part 2

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Total Unchanged Drug (Ae Total) for Part 2	203.853 milligrams	Geometric Coefficient of Variation 38.8
Gepotidacin 1500 mg RC Tablets	Total Unchanged Drug (Ae Total) for Part 2	546.263 milligrams	Geometric Coefficient of Variation 51.8

Primary

Total Unchanged Drug (Ae Total) for Part 3

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Total Unchanged Drug (Ae Total) for Part 3	390.099 milligrams	Geometric Coefficient of Variation 34.3
Gepotidacin 1500 mg RC Tablets	Total Unchanged Drug (Ae Total) for Part 3	613.635 milligrams	Geometric Coefficient of Variation 32.2
Gepotidacin 1500 mg HSWG Tablets	Total Unchanged Drug (Ae Total) for Part 3	895.556 milligrams	Geometric Coefficient of Variation 27.8

Primary

Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a

PK urine samples were collected at 0 (predose), 0 to 2, 2 ot 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a	274.925 milligrams	Geometric Coefficient of Variation 28.6
Gepotidacin 1500 mg RC Tablets	Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a	286.751 milligrams	Geometric Coefficient of Variation 22.2
Gepotidacin 1500 mg HSWG Tablets	Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a	284.510 milligrams	Geometric Coefficient of Variation 30

Primary

Urine Ae (t1-t2) for Part 3

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Group	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (0-2), n=10,10,9	27.763 milligrams	Geometric Coefficient of Variation 536.8
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (2-4), n=10,10,9	132.423 milligrams	Geometric Coefficient of Variation 67.6
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (4-6),n=9,10,9	63.314 milligrams	Geometric Coefficient of Variation 61.4
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (6-8),n=10,10,9	54.631 milligrams	Geometric Coefficient of Variation 57.4
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (8-12),n=10,10,9	35.322 milligrams	Geometric Coefficient of Variation 37.1
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (12-24),n=10,10,9	14.201 milligrams	Geometric Coefficient of Variation 40.3
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (24-36),n=10,10,9	6.510 milligrams	Geometric Coefficient of Variation 49
Gepotidacin 1500 mg - R Capsules	Urine Ae (t1-t2) for Part 3	Ae (36-48),n=10,10,8	3.265 milligrams	Geometric Coefficient of Variation 53.3
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (4-6),n=9,10,9	113.386 milligrams	Geometric Coefficient of Variation 36.9
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (6-8),n=10,10,9	48.536 milligrams	Geometric Coefficient of Variation 93.3
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (24-36),n=10,10,9	8.463 milligrams	Geometric Coefficient of Variation 55.4
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (8-12),n=10,10,9	48.906 milligrams	Geometric Coefficient of Variation 41
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (12-24),n=10,10,9	22.931 milligrams	Geometric Coefficient of Variation 65.9
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (0-2), n=10,10,9	54.827 milligrams	Geometric Coefficient of Variation 264.1
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (2-4), n=10,10,9	247.448 milligrams	Geometric Coefficient of Variation 45.5
Gepotidacin 1500 mg RC Tablets	Urine Ae (t1-t2) for Part 3	Ae (36-48),n=10,10,8	3.150 milligrams	Geometric Coefficient of Variation 71.5
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (4-6),n=9,10,9	175.739 milligrams	Geometric Coefficient of Variation 36.5
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (36-48),n=10,10,8	5.641 milligrams	Geometric Coefficient of Variation 42.4
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (2-4), n=10,10,9	333.805 milligrams	Geometric Coefficient of Variation 43
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (6-8),n=10,10,9	70.582 milligrams	Geometric Coefficient of Variation 70.7
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (0-2), n=10,10,9	142.546 milligrams	Geometric Coefficient of Variation 96.7
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (12-24),n=10,10,9	36.214 milligrams	Geometric Coefficient of Variation 65.8
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (8-12),n=10,10,9	47.392 milligrams	Geometric Coefficient of Variation 85.2
Gepotidacin 1500 mg HSWG Tablets	Urine Ae (t1-t2) for Part 3	Ae (24-36),n=10,10,9	12.642 milligrams	Geometric Coefficient of Variation 50.7

Primary

Urine AUC (0-12) for Part 3

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Urine AUC (0-12) for Part 3	1573 micrograms*hours/milliliter	Geometric Coefficient of Variation 48.3
Gepotidacin 1500 mg RC Tablets	Urine AUC (0-12) for Part 3	2812 micrograms*hours/milliliter	Geometric Coefficient of Variation 42.4
Gepotidacin 1500 mg HSWG Tablets	Urine AUC (0-12) for Part 3	3517 micrograms*hours/milliliter	Geometric Coefficient of Variation 52.4

Primary

Urine AUC (0-24) for Part 3

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Urine AUC (0-24) for Part 3	1879 micrograms*hours/milliliter	Geometric Coefficient of Variation 51.8
Gepotidacin 1500 mg RC Tablets	Urine AUC (0-24) for Part 3	3301 micrograms*hours/milliliter	Geometric Coefficient of Variation 45.5
Gepotidacin 1500 mg HSWG Tablets	Urine AUC (0-24) for Part 3	4197 micrograms*hours/milliliter	Geometric Coefficient of Variation 54.1

Primary

Urine AUC (0-48) for Part 3

Time frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.

Population: PK Parameter Population

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Urine AUC (0-48) for Part 3	2024 micrograms*hours/milliliter	Geometric Coefficient of Variation 54.3
Gepotidacin 1500 mg RC Tablets	Urine AUC (0-48) for Part 3	3455 micrograms*hours/milliliter	Geometric Coefficient of Variation 46.6
Gepotidacin 1500 mg HSWG Tablets	Urine AUC (0-48) for Part 3	4390 micrograms*hours/milliliter	Geometric Coefficient of Variation 54.1

Secondary

Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2

Blood samples were collected for the assessment of chemistry parameter namely serum estradiol for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the indicated time point were analyzed. NA indicates standard deviation was not calculated as a single participant was analyzed.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Value (MEAN)
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2	NA picomoles/liter
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2	0.00 picomoles/liter

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a

Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum ALT, Day 3 (48 hour), n=26, 26, 26	-1.1 International units/liter	Standard Deviation 7.04
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum ALT, Follow-up, n=8, 9, 9	-3.0 International units/liter	Standard Deviation 10.76
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AP, Day 3 (48 hour), n=26, 26, 26	7.7 International units/liter	Standard Deviation 5.69
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AP, Follow-up, n=8, 9, 9	2.6 International units/liter	Standard Deviation 6.07
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AST, Day 3 (48 hour),n=26, 26, 26	-0.6 International units/liter	Standard Deviation 4.11
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AST, Follow-up, n=8, 9, 9	-0.1 International units/liter	Standard Deviation 4.94
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum CK, Day 3 (48 hour),n=26, 26, 26	-28.7 International units/liter	Standard Deviation 43.65
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum CK, Follow-up, n=8, 9, 9	8.0 International units/liter	Standard Deviation 42.32
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AP, Day 3 (48 hour), n=26, 26, 26	8.3 International units/liter	Standard Deviation 5.4
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum CK, Day 3 (48 hour),n=26, 26, 26	-26.4 International units/liter	Standard Deviation 47.32
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AP, Follow-up, n=8, 9, 9	7.2 International units/liter	Standard Deviation 7.71
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AST, Day 3 (48 hour),n=26, 26, 26	-0.2 International units/liter	Standard Deviation 4.01
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AST, Follow-up, n=8, 9, 9	1.7 International units/liter	Standard Deviation 7.18
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum ALT, Day 3 (48 hour), n=26, 26, 26	-0.1 International units/liter	Standard Deviation 7.3
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum ALT, Follow-up, n=8, 9, 9	0.1 International units/liter	Standard Deviation 11.57
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum CK, Follow-up, n=8, 9, 9	29.0 International units/liter	Standard Deviation 107.27
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AP, Day 3 (48 hour), n=26, 26, 26	9.0 International units/liter	Standard Deviation 6.25
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum ALT, Follow-up, n=8, 9, 9	5.4 International units/liter	Standard Deviation 5.05
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum ALT, Day 3 (48 hour), n=26, 26, 26	-0.3 International units/liter	Standard Deviation 6.54
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AP, Follow-up, n=8, 9, 9	7.4 International units/liter	Standard Deviation 4.75
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum CK, Day 3 (48 hour),n=26, 26, 26	-30.2 International units/liter	Standard Deviation 41.96
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AST, Follow-up, n=8, 9, 9	3.1 International units/liter	Standard Deviation 4.4
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum AST, Day 3 (48 hour),n=26, 26, 26	-0.5 International units/liter	Standard Deviation 3.99
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a	Serum CK, Follow-up, n=8, 9, 9	13.2 International units/liter	Standard Deviation 26.16

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a

Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum albumin, Day 3 (48 hour), n=26, 26, 26	1.5 grams/liter	Standard Deviation 2.27
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum albumin, Follow-up, n=8, 9, 9	-0.3 grams/liter	Standard Deviation 2.55
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum protein, Day 3 (48 hour), n=26, 26, 26	1.8 grams/liter	Standard Deviation 4.68
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum protein, Follow-up, n=8, 9, 9	-2.1 grams/liter	Standard Deviation 4.29
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum protein, Follow-up, n=8, 9, 9	-2.6 grams/liter	Standard Deviation 3.32
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum albumin, Day 3 (48 hour), n=26, 26, 26	1.8 grams/liter	Standard Deviation 1.98
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum protein, Day 3 (48 hour), n=26, 26, 26	1.9 grams/liter	Standard Deviation 3.1
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum albumin, Follow-up, n=8, 9, 9	-0.7 grams/liter	Standard Deviation 1.87
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum protein, Follow-up, n=8, 9, 9	-2.1 grams/liter	Standard Deviation 4.43
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum albumin, Follow-up, n=8, 9, 9	-0.6 grams/liter	Standard Deviation 2.46
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum protein, Day 3 (48 hour), n=26, 26, 26	2.1 grams/liter	Standard Deviation 3.98
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a	Serum albumin, Day 3 (48 hour), n=26, 26, 26	1.8 grams/liter	Standard Deviation 2.36

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1b

Blood samples were collected for the assessment of chemistry parameters namely serum albuim and serum protein for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Population: Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2

Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum albumin, Day 3 (48 hour)	-0.9 grams/liter	Standard Deviation 3.38
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum albumin, Follow-up	NA grams/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum protein, Day 3 (48 hour)	0.0 grams/liter	Standard Deviation 5.29
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum protein, Follow-up,	NA grams/liter	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum protein, Follow-up,	-1.8 grams/liter	Standard Deviation 2.7
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum albumin, Day 3 (48 hour)	0.0 grams/liter	Standard Deviation 1.7
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum protein, Day 3 (48 hour)	-2.1 grams/liter	Standard Deviation 4.63
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2	Serum albumin, Follow-up	-1.5 grams/liter	Standard Deviation 2.17

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3

Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Part 1, Day 3 (48 hour), n=10,0,0,2	-2.0 grams/liter	Standard Deviation 2.54
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Period 1, Day 3 (48 hour), n=10,0,0,2	-3.0 grams/liter	Standard Deviation 2.31
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Period 2, Day 3 (48 hour), n=0,10,0,2	-2.2 grams/liter	Standard Deviation 3.01
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Period 2, Day 3 (48 hour), n=0,10,0,2	-2.0 grams/liter	Standard Deviation 1.05
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Follow-up, n=0,0,9,2	-0.3 grams/liter	Standard Deviation 3.12
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Period 3, Day 3 (48 hour), n=0,0,9,2	-0.6 grams/liter	Standard Deviation 3.97
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Period 3, Day 3 (48 hour), n=0,0,9,2	-0.6 grams/liter	Standard Deviation 3.05
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Follow-up, n=0,0,9,2	-0.6 grams/liter	Standard Deviation 4.64
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Period 2, Day 3 (48 hour), n=0,10,0,2	-5.0 grams/liter	Standard Deviation 1.41
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Period 3, Day 3 (48 hour), n=0,0,9,2	-4.5 grams/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Part 1, Day 3 (48 hour), n=10,0,0,2	-2.0 grams/liter	Standard Deviation 0
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Period 2, Day 3 (48 hour), n=0,10,0,2	-3.0 grams/liter	Standard Deviation 1.41
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Period 3, Day 3 (48 hour), n=0,0,9,2	-2.5 grams/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Albumin, Follow-up, n=0,0,9,2	-0.5 grams/liter	Standard Deviation 2.12
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Follow-up, n=0,0,9,2	-1.0 grams/liter	Standard Deviation 5.66
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3	Protein, Period 1, Day 3 (48 hour), n=10,0,0,2	-4.5 grams/liter	Standard Deviation 0.71

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 1b

Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3

Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Period 1, Day 3 (48 hour), n=10,0,0,2	0.1 International units/liter	Standard Deviation 2.73
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AP, Period 1, Day 3 (48 hour), n=10,0,0,2,	-3.6 International units/liter	Standard Deviation 2.07
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Period 1, Day 3 (48 hour),n=10,0,0,2	1.3 International units/liter	Standard Deviation 3.06
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Period 1, Day 3 (48 hour),n=10,0,0,2	-28.1 International units/liter	Standard Deviation 17.6
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Period 2, Day 3 (48 hour),n=0,10,0,2	1.7 International units/liter	Standard Deviation 2.5
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AP, Period 2, Day 3 (48 hour), n=0,10,0,2	-2.5 International units/liter	Standard Deviation 4.62
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Period 2, Day 3 (48 hour), n=0,10,0,2	2.2 International units/liter	Standard Deviation 3.36
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Period 2, Day 3 (48 hour),n=0,10,0,2	-11.8 International units/liter	Standard Deviation 65.84
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Period 3, Day 3 (48 hour), n=0,0,9,2,	6.0 International units/liter	Standard Deviation 3.74
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Follow-up, n=0,0,9,2	5.9 International units/liter	Standard Deviation 4.11
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	Serum AP, Day 3 (48 hour), n=0,0,9,2	0.6 International units/liter	Standard Deviation 3.88
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AP, Follow-up, n=0,0,9,2	1.8 International units/liter	Standard Deviation 3.96
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Follow-up, n=0,0,9,2	3.7 International units/liter	Standard Deviation 26.87
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Period 3, Day 3 (48 hour),n=0,0,9,2	4.2 International units/liter	Standard Deviation 2.68
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Follow-up, n=0,0,9,2	2.6 International units/liter	Standard Deviation 2.46
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Period 3, Day 3 (48 hour),n=0,0,9,2	-14.3 International units/liter	Standard Deviation 20.27
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Period 2, Day 3 (48 hour), n=0,10,0,2	-4.0 International units/liter	Standard Deviation 7.07
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Period 1, Day 3 (48 hour),n=10,0,0,2	-3.5 International units/liter	Standard Deviation 2.12
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Period 3, Day 3 (48 hour),n=0,0,9,2	-21.5 International units/liter	Standard Deviation 9.19
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Period 2, Day 3 (48 hour),n=0,10,0,2	-5.0 International units/liter	Standard Deviation 4.24
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Period 1, Day 3 (48 hour), n=10,0,0,2	-2.5 International units/liter	Standard Deviation 2.12
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Period 3, Day 3 (48 hour),n=0,0,9,2	-5.0 International units/liter	Standard Deviation 5.66
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Period 3, Day 3 (48 hour), n=0,0,9,2,	-4.5 International units/liter	Standard Deviation 9.19
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AST, Follow-up, n=0,0,9,2	-4.0 International units/liter	Standard Deviation 7.07
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Follow-up, n=0,0,9,2	1.0 International units/liter	Standard Deviation 11.31
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Period 1, Day 3 (48 hour),n=10,0,0,2	-22.5 International units/liter	Standard Deviation 14.85
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AP, Period 1, Day 3 (48 hour), n=10,0,0,2,	-9.0 International units/liter	Standard Deviation 5.66
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AP, Period 2, Day 3 (48 hour), n=0,10,0,2	-2.0 International units/liter	Standard Deviation 4.24
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	ALT, Follow-up, n=0,0,9,2	-5.0 International units/liter	Standard Deviation 11.31
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	Serum AP, Day 3 (48 hour), n=0,0,9,2	-0.5 International units/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	CK, Period 2, Day 3 (48 hour),n=0,10,0,2	-33.5 International units/liter	Standard Deviation 23.33
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3	AP, Follow-up, n=0,0,9,2	3.5 International units/liter	Standard Deviation 3.54

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2

Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum ALT, Day 3 (48 hour)	-0.2 International units/liter	Standard Deviation 1.55
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum ALT, Follow-up	NA International units/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AP, Day 3 (48 hour)	-0.3 International units/liter	Standard Deviation 5.44
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AP, Follow-up	NA International units/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AST, Day 3 (48 hour)	0.5 International units/liter	Standard Deviation 2.92
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AST, Follow-up	NA International units/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum CK, Day 3 (48 hour)	-22.7 International units/liter	Standard Deviation 26.45
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum CK, Follow-up	NA International units/liter	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum CK, Follow-up	-9.8 International units/liter	Standard Deviation 13.99
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum ALT, Day 3 (48 hour)	1.3 International units/liter	Standard Deviation 3.16
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AST, Day 3 (48 hour)	1.0 International units/liter	Standard Deviation 2.71
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum ALT, Follow-up	3.1 International units/liter	Standard Deviation 5.95
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum CK, Day 3 (48 hour)	-25.7 International units/liter	Standard Deviation 15.81
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AP, Day 3 (48 hour)	-0.3 International units/liter	Standard Deviation 4
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AST, Follow-up	3.5 International units/liter	Standard Deviation 4.81
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2	Serum AP, Follow-up	-1.7 International units/liter	Standard Deviation 2.95

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3

Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin and serum creatinine for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Period 1, Day 3 (48 hour), n=10,0,0,2	-2.43 micromoles/liter	Standard Deviation 3.364
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Period 1,Day 3 (48 hour), n=10,0,0,2	-1.75 micromoles/liter	Standard Deviation 8.101
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Period 2,Day 3 (48 hour), n=0,10,0,2	-1.75 micromoles/liter	Standard Deviation 6.958
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Period 2, Day 3 (48 hour), n=0,10,0,2,	-3.11 micromoles/liter	Standard Deviation 3.793
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Follow-up, n=0,0,9,2	-1.53 micromoles/liter	Standard Deviation 2.757
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Period 3,Day 3 (48 hour), n=0,0,9,2	0.01 micromoles/liter	Standard Deviation 7.636
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Period 3, Day 3 (48 hour), n=0,0,9,2	-2.28 micromoles/liter	Standard Deviation 3.844
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Follow-up, n=0,0,9,2	2.97 micromoles/liter	Standard Deviation 6.258
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Period 2,Day 3 (48 hour), n=0,10,0,2	-17.60 micromoles/liter	Standard Deviation 0
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Period 3,Day 3 (48 hour), n=0,0,9,2	-13.20 micromoles/liter	Standard Deviation 6.223
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Period 1, Day 3 (48 hour), n=10,0,0,2	-0.85 micromoles/liter	Standard Deviation 1.202
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Period 2, Day 3 (48 hour), n=0,10,0,2,	-1.70 micromoles/liter	Standard Deviation 0
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Period 3, Day 3 (48 hour), n=0,0,9,2	0.85 micromoles/liter	Standard Deviation 1.202
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Bilirubin, Follow-up, n=0,0,9,2	-1.70 micromoles/liter	Standard Deviation 0
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Follow-up, n=0,0,9,2	-4.40 micromoles/liter	Standard Deviation 6.223
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3	Creatinine, Period 1,Day 3 (48 hour), n=10,0,0,2	-17.65 micromoles/liter	Standard Deviation 12.516

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a

Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum bilirubin, Day 3 (48 hour), n=26, 26, 26	2.08 micromoles/liter	Standard Deviation 2.746
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum bilirubin, Follow-up, n=8, 9, 9	2.34 micromoles/liter	Standard Deviation 3.608
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum creatinine, Day 3 (48 hour), n=26, 26, 26	1.49 micromoles/liter	Standard Deviation 5.758
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum creatinine, Follow-up, n=8, 9, 9	4.86 micromoles/liter	Standard Deviation 5.349
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum direct bilirubin, Day 3 (48 hour),n=26,26,26	0.25 micromoles/liter	Standard Deviation 0.422
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum direct bilirubin, Follow-up, n=8, 9, 9	0.46 micromoles/liter	Standard Deviation 0.707
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum direct bilirubin, Follow-up, n=8, 9, 9	-0.14 micromoles/liter	Standard Deviation 0.384
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum bilirubin, Day 3 (48 hour), n=26, 26, 26	1.59 micromoles/liter	Standard Deviation 3.511
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum creatinine, Follow-up, n=8, 9, 9	2.28 micromoles/liter	Standard Deviation 9.93
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum direct bilirubin, Day 3 (48 hour),n=26,26,26	0.17 micromoles/liter	Standard Deviation 0.528
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum bilirubin, Follow-up, n=8, 9, 9	-1.08 micromoles/liter	Standard Deviation 1.943
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum creatinine, Day 3 (48 hour), n=26, 26, 26	2.14 micromoles/liter	Standard Deviation 6.793
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum bilirubin, Follow-up, n=8, 9, 9	-1.19 micromoles/liter	Standard Deviation 4.431
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum creatinine, Day 3 (48 hour), n=26, 26, 26	2.31 micromoles/liter	Standard Deviation 6.564
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum direct bilirubin, Follow-up, n=8, 9, 9	-0.09 micromoles/liter	Standard Deviation 0.677
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum creatinine, Follow-up, n=8, 9, 9	3.93 micromoles/liter	Standard Deviation 5.859
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum bilirubin, Day 3 (48 hour), n=26, 26, 26	1.98 micromoles/liter	Standard Deviation 3.018
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a	Serum direct bilirubin, Day 3 (48 hour),n=26,26,26	0.18 micromoles/liter	Standard Deviation 0.482

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2

Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum bilirubin, Day 3 (48 hour)	-1.02 micromoles/liter	Standard Deviation 2.944
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum bilirubin	NA micromoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum creatinine, Day 3 (48 hour)	-1.76 micromoles/liter	Standard Deviation 8.147
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum creatinine	NA micromoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum direct bilirubin, Day 3 (48 hour)	-0.51 micromoles/liter	Standard Deviation 1.147
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum direct bilirubin, Follow-up	NA micromoles/liter	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum direct bilirubin, Day 3 (48 hour)	-1.02 micromoles/liter	Standard Deviation 0.878
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum bilirubin, Day 3 (48 hour)	-3.62 micromoles/liter	Standard Deviation 2.968
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum creatinine	-3.55 micromoles/liter	Standard Deviation 7.458
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum bilirubin	-0.68 micromoles/liter	Standard Deviation 4.207
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum direct bilirubin, Follow-up	-0.34 micromoles/liter	Standard Deviation 1.075
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2	Serum creatinine, Day 3 (48 hour)	-4.42 micromoles/liter	Standard Deviation 6.254

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin in Part 1b

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a

Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum sodium, Day 3 (48 hour), n=26,26,26	-0.3 millimoles/liter	Standard Deviation 1.7
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum carbon dioxide, Follow-up, n=8, 9, 9	-1.4 millimoles/liter	Standard Deviation 1.19
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum calcium, Day 3 (48 hour), n=26, 26, 26	0.050 millimoles/liter	Standard Deviation 0.0968
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum potassium, Follow-up, n=8,9,9,	-0.18 millimoles/liter	Standard Deviation 0.306
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum chloride, Day 3 (48 hour),n=26, 26, 26	-1.0 millimoles/liter	Standard Deviation 1.78
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum glucose, Follow-up, n=8, 9, 9	0.099 millimoles/liter	Standard Deviation 0.3911
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum potassium, Day 3 (48 hour), n=26,26,26	-0.06 millimoles/liter	Standard Deviation 0.297
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum chloride, Follow-up, n=8, 9, 9	1.3 millimoles/liter	Standard Deviation 1.75
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum sodium, Follow-up, n=8,9,9	-1.0 millimoles/liter	Standard Deviation 2.39
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum calcium, Follow-up, n=8, 9, 9	0.003 millimoles/liter	Standard Deviation 0.0861
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum urea nitrogen, Follow-up, n=8,9,9	-0.043 millimoles/liter	Standard Deviation 1.4732
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum glucose, Day 3 (48 hour), n=26, 26, 26	0.010 millimoles/liter	Standard Deviation 0.2837
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum carbon dioxide, Day 3 (48 hour),n=26, 26, 26	-0.2 millimoles/liter	Standard Deviation 1.39
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum urea nitrogen, Day 3 (48 hour), n=26,26,26	-0.250 millimoles/liter	Standard Deviation 1.0929
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum sodium, Day 3 (48 hour), n=26,26,26	-0.7 millimoles/liter	Standard Deviation 1.67
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum glucose, Day 3 (48 hour), n=26, 26, 26	0.049 millimoles/liter	Standard Deviation 0.3253
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum glucose, Follow-up, n=8, 9, 9	0.304 millimoles/liter	Standard Deviation 0.518
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum calcium, Day 3 (48 hour), n=26, 26, 26	0.054 millimoles/liter	Standard Deviation 0.0802
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum calcium, Follow-up, n=8, 9, 9	-0.019 millimoles/liter	Standard Deviation 0.0692
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum carbon dioxide, Day 3 (48 hour),n=26, 26, 26	-0.2 millimoles/liter	Standard Deviation 1.22
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum carbon dioxide, Follow-up, n=8, 9, 9	-1.7 millimoles/liter	Standard Deviation 1.58
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum chloride, Day 3 (48 hour),n=26, 26, 26	-1.1 millimoles/liter	Standard Deviation 2
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum chloride, Follow-up, n=8, 9, 9	0.7 millimoles/liter	Standard Deviation 1.32
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum potassium, Day 3 (48 hour), n=26,26,26	-0.04 millimoles/liter	Standard Deviation 0.27
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum potassium, Follow-up, n=8,9,9,	-0.09 millimoles/liter	Standard Deviation 0.237
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum sodium, Follow-up, n=8,9,9	-1.3 millimoles/liter	Standard Deviation 2.35
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum urea nitrogen, Day 3 (48 hour), n=26,26,26	-0.307 millimoles/liter	Standard Deviation 1.0021
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum urea nitrogen, Follow-up, n=8,9,9	-0.354 millimoles/liter	Standard Deviation 1.0294
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum urea nitrogen, Day 3 (48 hour), n=26,26,26	-0.332 millimoles/liter	Standard Deviation 1.0598
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum potassium, Follow-up, n=8,9,9,	-0.24 millimoles/liter	Standard Deviation 0.371
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum carbon dioxide, Day 3 (48 hour),n=26, 26, 26	0.0 millimoles/liter	Standard Deviation 1.22
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum calcium, Follow-up, n=8, 9, 9	-0.046 millimoles/liter	Standard Deviation 0.0865
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum sodium, Day 3 (48 hour), n=26,26,26	-0.5 millimoles/liter	Standard Deviation 1.98
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum calcium, Day 3 (48 hour), n=26, 26, 26	0.051 millimoles/liter	Standard Deviation 0.07
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum glucose, Day 3 (48 hour), n=26, 26, 26	0.094 millimoles/liter	Standard Deviation 0.2699
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum sodium, Follow-up, n=8,9,9	-0.6 millimoles/liter	Standard Deviation 1.74
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum glucose, Follow-up, n=8, 9, 9	0.381 millimoles/liter	Standard Deviation 0.385
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum chloride, Follow-up, n=8, 9, 9	1.6 millimoles/liter	Standard Deviation 2.24
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum chloride, Day 3 (48 hour),n=26, 26, 26	-1.0 millimoles/liter	Standard Deviation 2.27
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum urea nitrogen, Follow-up, n=8,9,9	-0.223 millimoles/liter	Standard Deviation 1.0126
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum potassium, Day 3 (48 hour), n=26,26,26	-0.06 millimoles/liter	Standard Deviation 0.298
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a	Serum carbon dioxide, Follow-up, n=8, 9, 9	-1.6 millimoles/liter	Standard Deviation 1.33

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1b

Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3

Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide,Period 1,Day 3(48 hour),n=10,0,0,2	-0.6 millimoles/liter	Standard Deviation 1.51
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen,Period 1,Day 3 (48 hour),n=10,0,0,2	0.606 millimoles/liter	Standard Deviation 1.076
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Period 1, Day 3 (48 hour), n=10,0,0,2	-0.21 millimoles/liter	Standard Deviation 0.536
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Period 1, Day 3 (48 hour),n=10,0,0,2	0.8 millimoles/liter	Standard Deviation 1.23
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Period 1, Day 3 (48 hour), n=10,0,0,2	0.6 millimoles/liter	Standard Deviation 2.12
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium,Period1, Day 3 (48 hour),n=10,0,0,2	-0.057 millimoles/liter	Standard Deviation 0.0887
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose,Period 1,Day 3(48 hour),n=10,0,0,2	0.038 millimoles/liter	Standard Deviation 0.3178
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Period 2, Day 3 (48 hour), n=0,10,0,2	0.1 millimoles/liter	Standard Deviation 2.38
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose,Period 2,Day 3 (48 hour),n=0,10,0,2	-0.071 millimoles/liter	Standard Deviation 0.2993
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Period 2, Day 3 (48 hour), n=0,10,0,2	-0.19 millimoles/liter	Standard Deviation 0.381
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide,Period 2,Day 3(48 hour),n=0,10,0,2	-0.7 millimoles/liter	Standard Deviation 1.64
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium,Period 2,Day 3 (48 hour),n=0,10,0,2	-0.046 millimoles/liter	Standard Deviation 0.0819
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen,Period 2,Day 3 (48 hour),n=0,10,0,2	0.677 millimoles/liter	Standard Deviation 1.3401
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Period 2, Day 3 (48 hour),n=0,10,0,2	0.8 millimoles/liter	Standard Deviation 1.75
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Period 3, Day 3 (48 hour),n=0,0,9,2	0.1 millimoles/liter	Standard Deviation 1.96
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide, Follow-up, n=0,0,9,2	0.2 millimoles/liter	Standard Deviation 2.28
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Period 3, Day 3 (48 hour), n=0,0,9,2	0.3 millimoles/liter	Standard Deviation 1.94
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium,Period 3,Day 3 (48 hour),n=0,0,9,2	-0.028 millimoles/liter	Standard Deviation 0.0502
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Follow-up, n=0,0,9,2	-0.1 millimoles/liter	Standard Deviation 1.9
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Follow-up, n=0,0,9,2	-0.21 millimoles/liter	Standard Deviation 0.359
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Period 3, Day 3 (48 hour), n=0,0,9,2	-0.28 millimoles/liter	Standard Deviation 0.561
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose,Period 3,Day 3 (48 hour),n=0,0,9,2	-0.197 millimoles/liter	Standard Deviation 0.2355
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen, Follow-up, n=0,0,9,2	0.356 millimoles/liter	Standard Deviation 1.2998
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Follow-up,n=0,0,9,2	0.2 millimoles/liter	Standard Deviation 2.95
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen,Period 3,Day 3 (48 hour),n=0,0,9,2	0.474 millimoles/liter	Standard Deviation 1.4617
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium, Follow-up, n=0,0, 9, 2	-0.039 millimoles/liter	Standard Deviation 0.0742
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide,Period 3,Day 3(48 hour),n=0,0,9,2	-1.1 millimoles/liter	Standard Deviation 1.36
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose, Follow-up, n=0,0,9,2	-0.050 millimoles/liter	Standard Deviation 0.2744
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen, Follow-up, n=0,0,9,2	2.320 millimoles/liter	Standard Deviation 2.786
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose,Period 1,Day 3(48 hour),n=10,0,0,2	-0.305 millimoles/liter	Standard Deviation 0.4313
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose,Period 2,Day 3 (48 hour),n=0,10,0,2	-0.415 millimoles/liter	Standard Deviation 0.2758
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose,Period 3,Day 3 (48 hour),n=0,0,9,2	-0.335 millimoles/liter	Standard Deviation 0.1626
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Glucose, Follow-up, n=0,0,9,2	-0.390 millimoles/liter	Standard Deviation 0.396
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium,Period1, Day 3 (48 hour),n=10,0,0,2	-0.075 millimoles/liter	Standard Deviation 0.1061
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium,Period 2,Day 3 (48 hour),n=0,10,0,2	-0.115 millimoles/liter	Standard Deviation 0.0919
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium,Period 3,Day 3 (48 hour),n=0,0,9,2	-0.105 millimoles/liter	Standard Deviation 0.0354
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Calcium, Follow-up, n=0,0, 9, 2	-0.040 millimoles/liter	Standard Deviation 0.0141
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide,Period 1,Day 3(48 hour),n=10,0,0,2	0.5 millimoles/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide,Period 2,Day 3(48 hour),n=0,10,0,2	2.5 millimoles/liter	Standard Deviation 2.12
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide,Period 3,Day 3(48 hour),n=0,0,9,2	1.5 millimoles/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Carbon dioxide, Follow-up, n=0,0,9,2	1.5 millimoles/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Period 1, Day 3 (48 hour),n=10,0,0,2	1.0 millimoles/liter	Standard Deviation 2.83
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Period 2, Day 3 (48 hour),n=0,10,0,2	-2.0 millimoles/liter	Standard Deviation 0
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Period 3, Day 3 (48 hour),n=0,0,9,2	-1.5 millimoles/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Chloride, Follow-up,n=0,0,9,2	-2.0 millimoles/liter	Standard Deviation 0
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Period 1, Day 3 (48 hour), n=10,0,0,2	-0.10 millimoles/liter	Standard Deviation 0.283
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Period 2, Day 3 (48 hour), n=0,10,0,2	-0.40 millimoles/liter	Standard Deviation 1.131
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Period 3, Day 3 (48 hour), n=0,0,9,2	-0.30 millimoles/liter	Standard Deviation 1.273
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Potassium, Follow-up, n=0,0,9,2	-0.15 millimoles/liter	Standard Deviation 0.919
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Period 1, Day 3 (48 hour), n=10,0,0,2	2.5 millimoles/liter	Standard Deviation 2.12
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Period 2, Day 3 (48 hour), n=0,10,0,2	-1.0 millimoles/liter	Standard Deviation 2.83
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Period 3, Day 3 (48 hour), n=0,0,9,2	-2.0 millimoles/liter	Standard Deviation 4.24
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Sodium, Follow-up, n=0,0,9,2	-2.5 millimoles/liter	Standard Deviation 2.12
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen,Period 1,Day 3 (48 hour),n=10,0,0,2	0.535 millimoles/liter	Standard Deviation 0.2475
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen,Period 2,Day 3 (48 hour),n=0,10,0,2	1.610 millimoles/liter	Standard Deviation 0.7637
Placebo	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3	Urea nitrogen,Period 3,Day 3 (48 hour),n=0,0,9,2	1.075 millimoles/liter	Standard Deviation 0.0071

Secondary

Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2

Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum glucose, Day 3 (48 hour)	-0.146 millimoles/liter	Standard Deviation 0.4421
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum glucose, Follow-up	NA millimoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum calcium, Day 3 (48 hour)	-0.027 millimoles/liter	Standard Deviation 0.1055
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum calcium, Follow-up	NA millimoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum carbon dioxide, Day 3 (48 hour)	1.5 millimoles/liter	Standard Deviation 1.96
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum carbon dioxide, Follow-up	NA millimoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum chloride, Day 3 (48 hour)	-1.5 millimoles/liter	Standard Deviation 1.96
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum chloride, Follow-up	NA millimoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum potassium, Day 3 (48 hour)	-0.03 millimoles/liter	Standard Deviation 0.437
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum potassium, Follow-up	NA millimoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum sodium, Day 3 (48 hour)	-1.1 millimoles/liter	Standard Deviation 1.45
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum sodium, Follow-up	NA millimoles/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum urea nitrogen, Day 3 (48 hour)	0.678 millimoles/liter	Standard Deviation 0.8489
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum urea nitrogen, Follow-up	NA millimoles/liter	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum sodium, Day 3 (48 hour)	-0.9 millimoles/liter	Standard Deviation 2.02
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum glucose, Day 3 (48 hour)	-0.133 millimoles/liter	Standard Deviation 0.3665
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum chloride, Follow-up	0.1 millimoles/liter	Standard Deviation 2.13
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum glucose, Follow-up	-0.211 millimoles/liter	Standard Deviation 0.5005
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum urea nitrogen, Day 3 (48 hour)	1.321 millimoles/liter	Standard Deviation 1.2692
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum calcium, Day 3 (48 hour)	-0.009 millimoles/liter	Standard Deviation 0.0684
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum potassium, Day 3 (48 hour)	-0.16 millimoles/liter	Standard Deviation 0.517
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum calcium, Follow-up	-0.011 millimoles/liter	Standard Deviation 0.0638
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum sodium, Follow-up	0.4 millimoles/liter	Standard Deviation 2.22
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum carbon dioxide, Day 3 (48 hour)	-1.4 millimoles/liter	Standard Deviation 1.71
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum potassium, Follow-up	0.01 millimoles/liter	Standard Deviation 0.446
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum carbon dioxide, Follow-up	-0.4 millimoles/liter	Standard Deviation 1.78
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum urea nitrogen, Follow-up	0.216 millimoles/liter	Standard Deviation 1.7478
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2	Serum chloride, Day 3 (48 hour)	-1.2 millimoles/liter	Standard Deviation 2.04

Secondary

Change From Baseline in ECG Parameter Heart Rate for Part 1b

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in ECG Parameter Heart Rate for Part 2

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Day 1 (2 hours)	5.4 beats/minute	Standard Deviation 10.13
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Day 3 (48 hours)	2.1 beats/minute	Standard Deviation 11
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Day 2 (24 hours)	-1.2 beats/minute	Standard Deviation 8.75
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Follow-up	NA beats/minute	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Day 2 (24 hours)	-1.1 beats/minute	Standard Deviation 6.71
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Day 1 (2 hours)	4.9 beats/minute	Standard Deviation 5.02
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Follow-up	-1.6 beats/minute	Standard Deviation 8.18
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 2	ECG Heart rate, Day 3 (48 hours)	3.4 beats/minute	Standard Deviation 5.38

Secondary

Change From Baseline in ECG Parameter Heart Rate for Part 3

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period1,Day 3 (48 hours),n=10,0,0,2	4.8 beats/minute	Standard Deviation 6.75
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period1,Day 1 (2 hours),n=10,0,0,2	8.0 beats/minute	Standard Deviation 7.15
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period1,Day 2 (24 hours),n=10,0,0,2	-0.3 beats/minute	Standard Deviation 4.11
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period2,Day 3 (48 hours),n=0,10,0,2	-0.5 beats/minute	Standard Deviation 10.32
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period2,Day 1 (2 hours),n=0,10,0,2	6.4 beats/minute	Standard Deviation 8.88
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period2,Day 2 (24 hours),n=0,10,0,2	-0.2 beats/minute	Standard Deviation 8.78
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period3,Day 3 (48 hours),n=0,0,9,2	1.4 beats/minute	Standard Deviation 5.98
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period3,Day 2 (24 hours),n=0,0,9,2	4.6 beats/minute	Standard Deviation 13.61
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period3,Day 1 (2 hours),n=0,0,9,2	8.0 beats/minute	Standard Deviation 7.04
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate, Follow-up, n=0,0,9,2	-3.8 beats/minute	Standard Deviation 6.72
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period1,Day 1 (2 hours),n=10,0,0,2	5.0 beats/minute	Standard Deviation 8.49
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period2,Day 3 (48 hours),n=0,10,0,2	3.0 beats/minute	Standard Deviation 5.66
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period3,Day 1 (2 hours),n=0,0,9,2	5.5 beats/minute	Standard Deviation 6.36
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period3,Day 2 (24 hours),n=0,0,9,2	12.0 beats/minute	Standard Deviation 15.56
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period3,Day 3 (48 hours),n=0,0,9,2	5.0 beats/minute	Standard Deviation 9.9
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period1,Day 2 (24 hours),n=10,0,0,2	-4.0 beats/minute	Standard Deviation 4.24
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period1,Day 3 (48 hours),n=10,0,0,2	0.0 beats/minute	Standard Deviation 9.9
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period2,Day 1 (2 hours),n=0,10,0,2	10.0 beats/minute	Standard Deviation 7.07
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate, Follow-up, n=0,0,9,2	-1.0 beats/minute	Standard Deviation 0
Placebo	Change From Baseline in ECG Parameter Heart Rate for Part 3	ECG Heart rate,Period2,Day 2 (24 hours),n=0,10,0,2	8.0 beats/minute	Standard Deviation 8.49

Secondary

Change From Baseline in 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) for Part 1a

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1a. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QT interval, Day 2 (24 hours), n=26, 26, 26	1.5 milliseconds	Standard Deviation 11.55
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	PR interval, Day 1 (2 hours), n=26, 26, 26	-2.5 milliseconds	Standard Deviation 12.28
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcB, Day 3 (48 hours), n=26, 26, 26	2.0 milliseconds	Standard Deviation 12.56
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QRS duration, Day 3 (48 hours), n=26, 26, 26	0.1 milliseconds	Standard Deviation 4.47
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcF, Follow-up, n=8,9,9	15.4 milliseconds	Standard Deviation 20.16
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcB, Follow-up, n=8,9,9	13.9 milliseconds	Standard Deviation 19.95
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QRS duration, Day 1 (2 hours), n=26, 26, 26,	1.3 milliseconds	Standard Deviation 4.65
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcF, Day 3 (48 hours), n=26, 26, 26	2.0 milliseconds	Standard Deviation 8.3
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcF interval, Day 1 (2 hours), n=26, 26, 26,	7.5 milliseconds	Standard Deviation 10.56
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QT interval, Day 3 (48 hours), n=26, 26, 26	1.8 milliseconds	Standard Deviation 12.95
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcF, Day 2 (24 hours), n=26, 26, 26	1.7 milliseconds	Standard Deviation 9.11
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QT interval Day 1 (2 hours), n=26, 26, 26,	9.6 milliseconds	Standard Deviation 14.42
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	PR interval, Follow-up, n=8,9,9	4.0 milliseconds	Standard Deviation 14.89
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QT interval, Follow-up, n=8,9,9	17.5 milliseconds	Standard Deviation 22.99
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QRS duration, Follow-up, n=8,9,9	-0.4 milliseconds	Standard Deviation 7.21
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	PR interval,, Day 3 (48 hours), n=26, 26, 26	1.2 milliseconds	Standard Deviation 9.64
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcB interval, Day 1 (2 hours), n=26, 26, 26,	6.6 milliseconds	Standard Deviation 14.07
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QRS duration, Day 2 (24 hours), n=26, 26, 26	0.3 milliseconds	Standard Deviation 3.64
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	PR interval, Day 2 (24 hours), n=26, 26, 26	1.7 milliseconds	Standard Deviation 13.77
Gepotidacin 1500 mg - R Capsules	Change From Baseline in 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) for Part 1a	QTcB, Day 2 (24 hours), n=26, 26, 26	1.8 milliseconds	Standard Deviation 12.63
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Day 3 (48 hours), n=26, 26, 26	-0.1 milliseconds	Standard Deviation 5.42
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Follow-up, n=8,9,9	2.1 milliseconds	Standard Deviation 8.31
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QT interval Day 1 (2 hours), n=26, 26, 26,	6.4 milliseconds	Standard Deviation 12.07
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QT interval, Day 2 (24 hours), n=26, 26, 26	2.1 milliseconds	Standard Deviation 15.22
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QT interval, Day 3 (48 hours), n=26, 26, 26	-0.5 milliseconds	Standard Deviation 14.55
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QT interval, Follow-up, n=8,9,9	5.2 milliseconds	Standard Deviation 29.79
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcB interval, Day 1 (2 hours), n=26, 26, 26,	4.3 milliseconds	Standard Deviation 14.96
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcB, Day 2 (24 hours), n=26, 26, 26	1.7 milliseconds	Standard Deviation 13.74
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcB, Day 3 (48 hours), n=26, 26, 26	-1.6 milliseconds	Standard Deviation 13.26
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcB, Follow-up, n=8,9,9	2.9 milliseconds	Standard Deviation 19.62
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcF interval, Day 1 (2 hours), n=26, 26, 26,	4.8 milliseconds	Standard Deviation 11.05
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcF, Day 2 (24 hours), n=26, 26, 26	2.0 milliseconds	Standard Deviation 9.73
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcF, Day 3 (48 hours), n=26, 26, 26	-1.3 milliseconds	Standard Deviation 9.93
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QTcF, Follow-up, n=8,9,9	4.9 milliseconds	Standard Deviation 18.84
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	PR interval, Day 1 (2 hours), n=26, 26, 26	-3.2 milliseconds	Standard Deviation 11.79
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	PR interval, Day 2 (24 hours), n=26, 26, 26	-0.1 milliseconds	Standard Deviation 8.8
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	PR interval,, Day 3 (48 hours), n=26, 26, 26	-0.3 milliseconds	Standard Deviation 7.74
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	PR interval, Follow-up, n=8,9,9	-3.1 milliseconds	Standard Deviation 9.98
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Day 1 (2 hours), n=26, 26, 26,	0.1 milliseconds	Standard Deviation 5.61
Gepotidacin 1500 mg RC Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Day 2 (24 hours), n=26, 26, 26	-1.0 milliseconds	Standard Deviation 5.62
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcB, Day 2 (24 hours), n=26, 26, 26	3.8 milliseconds	Standard Deviation 9.86
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Day 1 (2 hours), n=26, 26, 26,	-0.4 milliseconds	Standard Deviation 4.64
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	PR interval, Day 1 (2 hours), n=26, 26, 26	-3.8 milliseconds	Standard Deviation 6.01
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcB interval, Day 1 (2 hours), n=26, 26, 26,	10.3 milliseconds	Standard Deviation 11.26
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QT interval Day 1 (2 hours), n=26, 26, 26,	8.8 milliseconds	Standard Deviation 11.28
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	PR interval, Day 2 (24 hours), n=26, 26, 26	-0.5 milliseconds	Standard Deviation 9.2
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QT interval, Follow-up, n=8,9,9	-3.6 milliseconds	Standard Deviation 17.81
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Day 3 (48 hours), n=26, 26, 26	-1.8 milliseconds	Standard Deviation 5.28
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	PR interval,, Day 3 (48 hours), n=26, 26, 26	2.0 milliseconds	Standard Deviation 12.51
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QT interval, Day 3 (48 hours), n=26, 26, 26	-0.7 milliseconds	Standard Deviation 10.8
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Day 2 (24 hours), n=26, 26, 26	-0.5 milliseconds	Standard Deviation 5.07
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcF interval, Day 1 (2 hours), n=26, 26, 26,	10.0 milliseconds	Standard Deviation 9.57
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	PR interval, Follow-up, n=8,9,9	-9.2 milliseconds	Standard Deviation 7.41
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcF, Day 2 (24 hours), n=26, 26, 26	3.4 milliseconds	Standard Deviation 7.21
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcB, Follow-up, n=8,9,9	6.0 milliseconds	Standard Deviation 11.51
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QT interval, Day 2 (24 hours), n=26, 26, 26	2.4 milliseconds	Standard Deviation 8.4
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcF, Day 3 (48 hours), n=26, 26, 26	1.8 milliseconds	Standard Deviation 8.2
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcB, Day 3 (48 hours), n=26, 26, 26	2.9 milliseconds	Standard Deviation 9.76
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QRS duration, Follow-up, n=8,9,9	0.9 milliseconds	Standard Deviation 2.26
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in 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) for Part 1a	QTcF, Follow-up, n=8,9,9	4.6 milliseconds	Standard Deviation 7.65

Secondary

Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 1b

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1b. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 2. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Day 3 (48 hours)	5.1 milliseconds	Standard Deviation 11.46
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval, Day 3 (48 hours)	-1.0 milliseconds	Standard Deviation 20.48
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Day 2 (24 hours)	0.3 milliseconds	Standard Deviation 4.57
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval, Follow-up	NA milliseconds	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Day 2 (24 hours)	7.2 milliseconds	Standard Deviation 11.44
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB interval, Day 1 (2 hours)	15.2 milliseconds	Standard Deviation 18.23
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Day 3 (48 hours)	-0.2 milliseconds	Standard Deviation 4.54
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB, Day 2 (24 hours)	3.4 milliseconds	Standard Deviation 11.64
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Follow-up	NA milliseconds	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB, Day 3 (48 hours)	6.6 milliseconds	Standard Deviation 16.26
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Follow-up	NA milliseconds	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB, Follow-up	NA milliseconds	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Day 1 (2 hours)	-1.7 milliseconds	Standard Deviation 13.92
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval Day 1 (2 hours)	-4.0 milliseconds	Standard Deviation 16.21
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF, Day 2 (24 hours)	4.0 milliseconds	Standard Deviation 10.23
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Day 1 (2 hours)	0.4 milliseconds	Standard Deviation 5.19
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF, Day 3 (48 hours)	4.0 milliseconds	Standard Deviation 8.6
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval, Day 2 (24 hours)	4.8 milliseconds	Standard Deviation 21.63
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF, Follow-up	NA milliseconds	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF interval, Day 1 (2 hours)	8.6 milliseconds	Standard Deviation 9.56
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF, Follow-up	7.0 milliseconds	Standard Deviation 9.36
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Day 1 (2 hours)	0.5 milliseconds	Standard Deviation 11.49
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Day 2 (24 hours)	-2.7 milliseconds	Standard Deviation 7.23
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Day 3 (48 hours)	3.0 milliseconds	Standard Deviation 11.71
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	PR interval, Follow-up	-1.2 milliseconds	Standard Deviation 15.37
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Day 1 (2 hours)	3.9 milliseconds	Standard Deviation 4.28
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Day 2 (24 hours)	-0.2 milliseconds	Standard Deviation 4.73
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Day 3 (48 hours)	0.7 milliseconds	Standard Deviation 4.06
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QRS duration, Follow-up	1.6 milliseconds	Standard Deviation 3.6
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval Day 1 (2 hours)	5.1 milliseconds	Standard Deviation 16.04
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval, Day 2 (24 hours)	11.7 milliseconds	Standard Deviation 17.31
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval, Day 3 (48 hours)	-3.4 milliseconds	Standard Deviation 14.95
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QT interval, Follow-up	9.5 milliseconds	Standard Deviation 17.37
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB interval, Day 1 (2 hours)	20.7 milliseconds	Standard Deviation 14.17
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB, Day 2 (24 hours)	9.5 milliseconds	Standard Deviation 8.24
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB, Day 3 (48 hours)	6.0 milliseconds	Standard Deviation 13
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcB, Follow-up	5.7 milliseconds	Standard Deviation 13.44
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF interval, Day 1 (2 hours)	15.2 milliseconds	Standard Deviation 13.09
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF, Day 2 (24 hours)	10.4 milliseconds	Standard Deviation 8.75
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2	QTcF, Day 3 (48 hours)	2.4 milliseconds	Standard Deviation 11.64

Secondary

Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 3. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period1,Day 3 (48 hours), n=10,0,0,2	-3.7 milliseconds	Standard Deviation 9.08
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 1,Day 1 (2 hours),n=10,0,0,2	2.0 milliseconds	Standard Deviation 10.73
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 1,Day 2(24 hours),n=10,0,0,2	7.9 milliseconds	Standard Deviation 19.45
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 1,Day 3 (48 hours),n=10,0,0,2	0.5 milliseconds	Standard Deviation 10.5
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 1, Day 3(48 hours),n=10,0,0,2	0.4 milliseconds	Standard Deviation 22.89
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB ,Period 1, Day 1 (2 hours), n=10,0,0,2	16.4 milliseconds	Standard Deviation 25.48
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 1, Day 3 (48 hours), n=10,0,0,2	10.5 milliseconds	Standard Deviation 14.75
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 1, Day 2 (24 hours), n=10,0,0,2	8.6 milliseconds	Standard Deviation 16.1
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 1, Day 2 (24 hours), n=10,0,0,2	8.3 milliseconds	Standard Deviation 16.09
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 1, Day 3 (48 hours), n=10,0,0,2	15.7 milliseconds	Standard Deviation 14.7
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 1, Day 1 (2 hours), n=10,0,0,2	7.7 milliseconds	Standard Deviation 20.94
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 1, Day 1(2 hours),n=10,0,0,2	-9.2 milliseconds	Standard Deviation 19.47
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 1,Day 2 (24 hours),n=10,0,0,2	4.3 milliseconds	Standard Deviation 8.63
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Period1,Day 1 (2 hours),n=10,0,0,2	-3.3 milliseconds	Standard Deviation 12.58
Gepotidacin 1500 mg - R Capsules	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Period1,Day 2 (24 hours),n=10,0,0,2	-1.9 milliseconds	Standard Deviation 7.82
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 2, Day 2 (24 hours), n=0,10,0,2	5.1 milliseconds	Standard Deviation 13.98
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 2, Day 1 (2 hours), n=0,10,0,2	15.1 milliseconds	Standard Deviation 20.18
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Period2, Day 3 (48 hours),n=0,10,0,2	-3.5 milliseconds	Standard Deviation 13.92
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 2,Day 1 (2 hours),n=0,10,0,2	-7.5 milliseconds	Standard Deviation 12.7
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 2, Day 2 (24 hours),n=0,10,0,2	-2.2 milliseconds	Standard Deviation 9.02
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 2, Day 1 (2 hours),n=0,10,0,2	-4.0 milliseconds	Standard Deviation 22.45
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 2, Day 3 (48 hours),n=0,10,0,2	-1.1 milliseconds	Standard Deviation 6.4
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 2, Day 2 (24 hours),n=0,10,0,2	0.4 milliseconds	Standard Deviation 7.07
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 2,Day 1 (2 hours),n=0,10,0,2	1.8 milliseconds	Standard Deviation 4.71
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 2, Day 3 (48 hours),n=0,10,0,2	0.0 milliseconds	Standard Deviation 26.86
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 2, Day 3 (48 hours), n=0,10,0,2	1.2 milliseconds	Standard Deviation 10.25
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 2, Day 2 (24 hours), n=0,10,0,2	4.5 milliseconds	Standard Deviation 7.09
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 2, Day 2 (24 hours),n=0,10,0,2	3.7 milliseconds	Standard Deviation 15.93
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 2, Day 1 (2 hours), n=0,10,0,2	8.4 milliseconds	Standard Deviation 17.65
Gepotidacin 1500 mg RC Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 2, Day 3 (48 hours), n=0,10,0,2	1.8 milliseconds	Standard Deviation 12.99
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 3,Day 2 (24 hours),n=0,0,9,2	4.8 milliseconds	Standard Deviation 13.94
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 3,Day 3 (48 hours), n=0,0,9,2	0.3 milliseconds	Standard Deviation 16.18
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 3, Day 2 (24 hours),n=0,0,9,2	-6.2 milliseconds	Standard Deviation 24.03
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 3, Day 3 (48 hours),n=0,0,9,2	-3.0 milliseconds	Standard Deviation 15.28
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval, Follow-up, n=0,0,9,2	11.4 milliseconds	Standard Deviation 17.84
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 3, Day 2 (24 hours), n=0,0,9,2	5.8 milliseconds	Standard Deviation 11.14
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 3,Day 1 (2 hours),n=0,0,9,2	-0.1 milliseconds	Standard Deviation 6.77
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Follow-up, n=0,0,9,2	6.1 milliseconds	Standard Deviation 11.95
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 3, Day 1 (2 hours), n=0,0,9,2	14.9 milliseconds	Standard Deviation 21.83
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 3, Day 3 (48 hours), n=0,0,9,2	2.1 milliseconds	Standard Deviation 10.02
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Follow-up, n=0,0,9,2	1.9 milliseconds	Standard Deviation 14.88
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 3, Day 1 (2 hours), n=0,0,9,2	6.8 milliseconds	Standard Deviation 16.15
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 3, Day 2 (24 hours), n=0,0,9,2	1.2 milliseconds	Standard Deviation 4.99
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 3, Day 3 (48 hours), n=0,0,9,2	0.2 milliseconds	Standard Deviation 9.18
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Follow-up, n=0,0,9,2	5.2 milliseconds	Standard Deviation 13.55
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 3,Day 1(2 hours),n=0,0,9,2	2.9 milliseconds	Standard Deviation 4.65
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 3,Day 2(24 hours),n=0,0,9,2	-2.6 milliseconds	Standard Deviation 4.39
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period3, Day 3(48 hours),n=0,0,9,2	-1.1 milliseconds	Standard Deviation 8.74
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration, Follow-up, n=0,0,9,2	-0.7 milliseconds	Standard Deviation 6.52
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 3, Day 1 (2 hours),n=0,0,9,2	-7.9 milliseconds	Standard Deviation 11.61
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 2, Day 3 (48 hours), n=0,10,0,2	5.5 milliseconds	Standard Deviation 13.44
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 2, Day 3 (48 hours),n=0,10,0,2	-3.0 milliseconds	Standard Deviation 2.83
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 3, Day 2 (24 hours), n=0,0,9,2	18.5 milliseconds	Standard Deviation 12.02
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration, Follow-up, n=0,0,9,2	4.5 milliseconds	Standard Deviation 7.78
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 3, Day 3 (48 hours), n=0,0,9,2	-3.0 milliseconds	Standard Deviation 8.49
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 3,Day 1(2 hours),n=0,0,9,2	1.5 milliseconds	Standard Deviation 4.95
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Follow-up, n=0,0,9,2	6.5 milliseconds	Standard Deviation 6.36
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 1, Day 3 (48 hours), n=10,0,0,2	-1.0 milliseconds	Standard Deviation 19.8
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 1, Day 1 (2 hours), n=10,0,0,2	-6.0 milliseconds	Standard Deviation 5.66
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 1, Day 2 (24 hours), n=10,0,0,2	-19.5 milliseconds	Standard Deviation 9.19
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 1, Day 2 (24 hours), n=10,0,0,2	-15.0 milliseconds	Standard Deviation 14.14
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB ,Period 1, Day 1 (2 hours), n=10,0,0,2	-1.0 milliseconds	Standard Deviation 2.83
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 1, Day 3 (48 hours), n=10,0,0,2	-1.0 milliseconds	Standard Deviation 8.49
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval, Follow-up, n=0,0,9,2	8.5 milliseconds	Standard Deviation 6.36
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 2, Day 1 (2 hours), n=0,10,0,2	5.0 milliseconds	Standard Deviation 14.14
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 3, Day 3 (48 hours),n=0,0,9,2	-15.0 milliseconds	Standard Deviation 36.77
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 2, Day 2 (24 hours), n=0,10,0,2	2.5 milliseconds	Standard Deviation 19.09
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 3, Day 2 (24 hours),n=0,0,9,2	-15.0 milliseconds	Standard Deviation 28.28
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 2, Day 3 (48 hours), n=0,10,0,2	2.5 milliseconds	Standard Deviation 7.78
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 1,Day 3 (48 hours),n=10,0,0,2	2.0 milliseconds	Standard Deviation 4.24
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 3, Day 1 (2 hours), n=0,0,9,2	-1.5 milliseconds	Standard Deviation 20.51
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 1, Day 3(48 hours),n=10,0,0,2	-0.5 milliseconds	Standard Deviation 12.02
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 3, Day 2 (24 hours), n=0,0,9,2	7.0 milliseconds	Standard Deviation 2.83
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 1,Day 2 (24 hours),n=10,0,0,2	-3.0 milliseconds	Standard Deviation 7.07
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Period 3, Day 3 (48 hours), n=0,0,9,2	-7.0 milliseconds	Standard Deviation 18.38
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 2, Day 1 (2 hours),n=0,10,0,2	-14.5 milliseconds	Standard Deviation 23.33
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcF, Follow-up, n=0,0,9,2	7.0 milliseconds	Standard Deviation 7.07
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 3, Day 1 (2 hours),n=0,0,9,2	-12.5 milliseconds	Standard Deviation 31.82
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 2,Day 1 (2 hours),n=0,10,0,2	2.0 milliseconds	Standard Deviation 7.07
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 1,Day 2(24 hours),n=10,0,0,2	-6.0 milliseconds	Standard Deviation 24.04
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 2, Day 2 (24 hours),n=0,10,0,2	-2.5 milliseconds	Standard Deviation 19.09
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 1, Day 1(2 hours),n=10,0,0,2	-15.0 milliseconds	Standard Deviation 19.8
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 2, Day 3 (48 hours),n=0,10,0,2	1.5 milliseconds	Standard Deviation 3.54
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 1,Day 1 (2 hours),n=10,0,0,2	3.5 milliseconds	Standard Deviation 9.19
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QT interval,Period 2, Day 2 (24 hours),n=0,10,0,2	-12.5 milliseconds	Standard Deviation 31.82
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period 3,Day 2(24 hours),n=0,0,9,2	8.0 milliseconds	Standard Deviation 8.49
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 2,Day 1 (2 hours),n=0,10,0,2	-8.5 milliseconds	Standard Deviation 0.71
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 2, Day 2 (24 hours),n=0,10,0,2	1.0 milliseconds	Standard Deviation 4.24
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period1,Day 3 (48 hours), n=10,0,0,2	0.0 milliseconds	Standard Deviation 4.24
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Period2, Day 3 (48 hours),n=0,10,0,2	3.0 milliseconds	Standard Deviation 1.41
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 3,Day 2 (24 hours),n=0,0,9,2	0.5 milliseconds	Standard Deviation 7.78
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 3,Day 1 (2 hours),n=0,0,9,2	-4.0 milliseconds	Standard Deviation 14.14
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval,Period 3,Day 3 (48 hours), n=0,0,9,2	4.0 milliseconds	Standard Deviation 16.97
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QRS duration,Period3, Day 3(48 hours),n=0,0,9,2	3.5 milliseconds	Standard Deviation 14.85
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Follow-up, n=0,0,9,2	-6.0 milliseconds	Standard Deviation 24.04
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Period1,Day 2 (24 hours),n=10,0,0,2	-1.0 milliseconds	Standard Deviation 5.66
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 2, Day 1 (2 hours), n=0,10,0,2	15.0 milliseconds	Standard Deviation 8.49
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	PR interval, Period1,Day 1 (2 hours),n=10,0,0,2	-1.0 milliseconds	Standard Deviation 5.66
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 2, Day 2 (24 hours), n=0,10,0,2	9.5 milliseconds	Standard Deviation 12.02
Placebo	Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3	QTcB, Period 3, Day 1 (2 hours), n=0,0,9,2	4.0 milliseconds	Standard Deviation 14.14

Secondary

Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a

A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 1 (2 hours), n=26, 26, 26,	-1.1 beats per minute	Standard Deviation 6.33
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 2 (24 hours), n=26, 26, 26	0.2 beats per minute	Standard Deviation 5.85
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 3 (48 hours), n=26, 26, 26	0.0 beats per minute	Standard Deviation 6.39
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Follow-up, n=8,9,9	-1.0 beats per minute	Standard Deviation 4.11
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Follow-up, n=8,9,9	0.7 beats per minute	Standard Deviation 8.82
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 1 (2 hours), n=26, 26, 26,	-1.0 beats per minute	Standard Deviation 6.05
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 3 (48 hours), n=26, 26, 26	-0.6 beats per minute	Standard Deviation 7
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 2 (24 hours), n=26, 26, 26	-0.4 beats per minute	Standard Deviation 8.02
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Follow-up, n=8,9,9	3.6 beats per minute	Standard Deviation 6.56
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 2 (24 hours), n=26, 26, 26	0.3 beats per minute	Standard Deviation 3.96
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 3 (48 hours), n=26, 26, 26	1.0 beats per minute	Standard Deviation 4.04
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a	ECG Heart rate, Day 1 (2 hours), n=26, 26, 26,	0.4 beats per minute	Standard Deviation 3.6

Secondary

Change From Baseline in Hematology Parameter Blood Ery. for Part 1a

Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. for Part 1a	Blood Ery. , Day 3 (48 hour), n=26, 26, 26	0.279 10^12 cells/liter	Standard Deviation 0.2597
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. for Part 1a	Blood Ery. , Follow-up, n=8, 9, 9	-0.130 10^12 cells/liter	Standard Deviation 0.2045
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 1a	Blood Ery. , Follow-up, n=8, 9, 9	-0.190 10^12 cells/liter	Standard Deviation 0.2258
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 1a	Blood Ery. , Day 3 (48 hour), n=26, 26, 26	0.293 10^12 cells/liter	Standard Deviation 0.245
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 1a	Blood Ery. , Follow-up, n=8, 9, 9	-0.101 10^12 cells/liter	Standard Deviation 0.2538
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 1a	Blood Ery. , Day 3 (48 hour), n=26, 26, 26	0.296 10^12 cells/liter	Standard Deviation 0.2538

Secondary

Change From Baseline in Hematology Parameter Blood Ery. for Part 1b

Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Hematology Parameter Blood Ery. for Part 2

Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. for Part 2	Blood Ery., Day 3 (48 hour)	0.118 10^12 cells/liter	Standard Deviation 0.2839
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. for Part 2	Blood Ery., Follow-up	NA 10^12 cells/liter	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 2	Blood Ery., Day 3 (48 hour)	0.033 10^12 cells/liter	Standard Deviation 0.1675
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 2	Blood Ery., Follow-up	-0.175 10^12 cells/liter	Standard Deviation 0.1099

Secondary

Change From Baseline in Hematology Parameter Blood Ery. for Part 3

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery., Period 1, Day 3 (48 hour), n=10,0,0,2	-0.065 10^12 cells/liter	Standard Deviation 0.2576
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery.,Period 2, Day 3 (48 hour), n=0,10,0,2	-0.138 10^12 cells/liter	Standard Deviation 0.3381
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery., Period 3, Day 3 (48 hour), n=0,0,9,2	-0.060 10^12 cells/liter	Standard Deviation 0.2536
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery., Follow-up, n=0,0,9,2	-0.253 10^12 cells/liter	Standard Deviation 0.3347
Placebo	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery., Period 1, Day 3 (48 hour), n=10,0,0,2	-0.275 10^12 cells/liter	Standard Deviation 0.0354
Placebo	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery., Period 3, Day 3 (48 hour), n=0,0,9,2	-0.340 10^12 cells/liter	Standard Deviation 0.0566
Placebo	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery., Follow-up, n=0,0,9,2	-0.210 10^12 cells/liter	Standard Deviation 0.3111
Placebo	Change From Baseline in Hematology Parameter Blood Ery. for Part 3	Ery.,Period 2, Day 3 (48 hour), n=0,10,0,2	-0.390 10^12 cells/liter	Standard Deviation 0.0566

Secondary

Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 1b

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2	Blood Ery.MCH, Day 3 (48 hour)	-0.25 picograms	Standard Deviation 0.331
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2	Blood Ery. MCH, Follow-up	NA picograms	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2	Blood Ery.MCH, Day 3 (48 hour)	-0.06 picograms	Standard Deviation 0.378
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2	Blood Ery. MCH, Follow-up	-0.15 picograms	Standard Deviation 0.488

Secondary

Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery.MCH, Period 1, Day 3 (48 hour), n=10,0,0,2	0.08 picograms	Standard Deviation 0.397
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery.MCH, Period 2, Day 3 (48 hour), n=0,10,0,2	0.08 picograms	Standard Deviation 0.27
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery.MCH, Period 3 Day 3 (48 hour), n=0,0,9,2	-0.12 picograms	Standard Deviation 0.38
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery. MCH, Follow-up, n=0,0,9,2	0.31 picograms	Standard Deviation 0.483
Placebo	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery.MCH, Period 1, Day 3 (48 hour), n=10,0,0,2	0.25 picograms	Standard Deviation 0.071
Placebo	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery.MCH, Period 3 Day 3 (48 hour), n=0,0,9,2	0.00 picograms	Standard Deviation 0.283
Placebo	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery. MCH, Follow-up, n=0,0,9,2	0.00 picograms	Standard Deviation 0.424
Placebo	Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3	Ery.MCH, Period 2, Day 3 (48 hour), n=0,10,0,2	0.15 picograms	Standard Deviation 0.212

Secondary

Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 1b

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2	Blood Ery. MCV, Day 3 (48 hour)	1.17 femtoliters	Standard Deviation 1.61
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2	Blood Ery. MCV, Follow-up	NA femtoliters	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2	Blood Ery. MCV, Day 3 (48 hour)	1.69 femtoliters	Standard Deviation 1.371
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2	Blood Ery. MCV, Follow-up	1.28 femtoliters	Standard Deviation 1.834

Secondary

Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a	Blood Ery.MCH, Day 3 (48 hour), n=26, 26, 26	-0.03 picograms	Standard Deviation 0.36
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a	Blood Ery. MCH, Follow-up, n=8, 9, 9	-0.03 picograms	Standard Deviation 0.512
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a	Blood Ery.MCH, Day 3 (48 hour), n=26, 26, 26	0.00 picograms	Standard Deviation 0.28
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a	Blood Ery. MCH, Follow-up, n=8, 9, 9	0.14 picograms	Standard Deviation 0.27
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a	Blood Ery.MCH, Day 3 (48 hour), n=26, 26, 26	-0.02 picograms	Standard Deviation 0.4
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a	Blood Ery. MCH, Follow-up, n=8, 9, 9	0.04 picograms	Standard Deviation 0.317

Secondary

Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a	Blood Ery. MCV, Day 3 (48 hour), n=26, 26, 26	-0.21 femtoliters	Standard Deviation 0.471
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a	Blood Ery. MCV, Follow-up, n=8, 9, 9	-0.73 femtoliters	Standard Deviation 0.618
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a	Blood Ery. MCV, Day 3 (48 hour), n=26, 26, 26	-0.26 femtoliters	Standard Deviation 0.568
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a	Blood Ery. MCV, Follow-up, n=8, 9, 9	-0.58 femtoliters	Standard Deviation 0.549
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a	Blood Ery. MCV, Day 3 (48 hour), n=26, 26, 26	-0.23 femtoliters	Standard Deviation 0.586
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a	Blood Ery. MCV, Follow-up, n=8, 9, 9	-0.72 femtoliters	Standard Deviation 0.8

Secondary

Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3

Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Period 1, Day 3 (48 hour), n=10,0,0,2	1.10 femtoliters	Standard Deviation 1.152
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Period 2, Day 3 (48 hour), n=0,10,0,2	1.14 femtoliters	Standard Deviation 0.857
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Period 3, Day 3 (48 hour), n=0,0,9,2	1.16 femtoliters	Standard Deviation 1.167
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Follow-up, n=0,0,9,2	1.31 femtoliters	Standard Deviation 1.43
Placebo	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Period 1, Day 3 (48 hour), n=10,0,0,2	1.30 femtoliters	Standard Deviation 2.97
Placebo	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Period 3, Day 3 (48 hour), n=0,0,9,2	1.80 femtoliters	Standard Deviation 0
Placebo	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Follow-up, n=0,0,9,2	0.00 femtoliters	Standard Deviation 1.131
Placebo	Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3	Ery. MCV, Period 2, Day 3 (48 hour), n=0,10,0,2	0.70 femtoliters	Standard Deviation 2.121

Secondary

Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a

Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a	Blood hematocrit , Day 3 (48 hour), n=26, 26, 26	2.32 Percentage of red blood cells in blood	Standard Deviation 2.212
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a	Blood hematocrit, Follow-up, n=8, 9, 9	-1.50 Percentage of red blood cells in blood	Standard Deviation 1.628
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a	Blood hematocrit , Day 3 (48 hour), n=26, 26, 26	2.43 Percentage of red blood cells in blood	Standard Deviation 2.11
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a	Blood hematocrit, Follow-up, n=8, 9, 9	-1.87 Percentage of red blood cells in blood	Standard Deviation 1.781
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a	Blood hematocrit , Day 3 (48 hour), n=26, 26, 26	2.48 Percentage of red blood cells in blood	Standard Deviation 2.2
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a	Blood hematocrit, Follow-up, n=8, 9, 9	-1.20 Percentage of red blood cells in blood	Standard Deviation 2.029

Secondary

Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1b

Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2

Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2	Blood hematocrit , Day 3 (48 hour)	1.6 Percentage of red blood cells in blood	Standard Deviation 2.871
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2	Blood hematocrit, Follow-up	NA Percentage of red blood cells in blood	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2	Blood hematocrit , Day 3 (48 hour)	1.02 Percentage of red blood cells in blood	Standard Deviation 1.713
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2	Blood hematocrit, Follow-up	-1.09 Percentage of red blood cells in blood	Standard Deviation 1.079

Secondary

Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3

Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Period 1,Day 3 (48 hour), n=10,0,0,2	-0.02 Percentage of red blood cells in blood	Standard Deviation 2.17
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Period 2,Day 3 (48 hour), n=0,10,0,2	-0.65 Percentage of red blood cells in blood	Standard Deviation 2.991
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Period 3,Day 3 (48 hour), n=0,0,9,2	0.02 Percentage of red blood cells in blood	Standard Deviation 2.299
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Follow-up, n=0,0,9,2	-1.67 Percentage of red blood cells in blood	Standard Deviation 2.545
Placebo	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Period 1,Day 3 (48 hour), n=10,0,0,2	-2 Percentage of red blood cells in blood	Standard Deviation 0.99
Placebo	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Period 3,Day 3 (48 hour), n=0,0,9,2	-2.35 Percentage of red blood cells in blood	Standard Deviation 0.495
Placebo	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Follow-up, n=0,0,9,2	-1.95 Percentage of red blood cells in blood	Standard Deviation 2.333
Placebo	Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3	Hematocrit, Period 2,Day 3 (48 hour), n=0,10,0,2	-3.3 Percentage of red blood cells in blood	Standard Deviation 0.424

Secondary

Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a

Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood neutrophils, Day 3 (48 hour),n=26, 26, 26	-0.254 10^9 cells/liter	Standard Deviation 0.5907
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood leukocytes, Follow-up, n=8, 9, 9	-0.175 10^9 cells/liter	Standard Deviation 0.4862
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood eosinophils, Day 3 (48 hour), n=26, 26, 26	0.008 10^9 cells/liter	Standard Deviation 0.0688
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood monocytes, Follow-up, n=8, 9, 9	0.050 10^9 cells/liter	Standard Deviation 0.0926
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood lymphocytes, Day 3 (48 hour),n=26, 26, 26	-0.050 10^9 cells/liter	Standard Deviation 0.2832
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood basophils, Follow-up, n=8, 9, 9	0.000 10^9 cells/liter	Standard Deviation 0
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood monocytes, Day 3 (48 hour),n=26, 26, 26	-0.065 10^9 cells/liter	Standard Deviation 0.0977
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood lymphocytes, Follow-up, n=8, 9, 9	0.025 10^9 cells/liter	Standard Deviation 0.2866
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood neutrophils, Follow-up, n=8, 9, 9	-0.213 10^9 cells/liter	Standard Deviation 0.533
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood eosinophils, Follow-up, n=8, 9, 9	0.025 10^9 cells/liter	Standard Deviation 0.0463
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood platelets, Follow-up, n=8, 9, 9	3.8 10^9 cells/liter	Standard Deviation 17.9
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood basophils, Day 3 (48 hour), n=26, 26, 26	0.004 10^9 cells/liter	Standard Deviation 0.0344
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood leukocytes, Day 3 (48 hour),n=26, 26, 26	-0.388 10^9 cells/liter	Standard Deviation 0.7464
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood platelets, Day 3 (48 hour),n=26, 26, 26	11.5 10^9 cells/liter	Standard Deviation 14.76
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood neutrophils, Day 3 (48 hour),n=26, 26, 26	-0.238 10^9 cells/liter	Standard Deviation 0.5845
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood basophils, Day 3 (48 hour), n=26, 26, 26	0.004 10^9 cells/liter	Standard Deviation 0.0344
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood basophils, Follow-up, n=8, 9, 9	0.000 10^9 cells/liter	Standard Deviation 0.05
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood eosinophils, Day 3 (48 hour), n=26, 26, 26	0.008 10^9 cells/liter	Standard Deviation 0.0935
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood eosinophils, Follow-up, n=8, 9, 9	0.044 10^9 cells/liter	Standard Deviation 0.0527
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood leukocytes, Day 3 (48 hour),n=26, 26, 26	-0.300 10^9 cells/liter	Standard Deviation 0.6957
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood leukocytes, Follow-up, n=8, 9, 9	0.000 10^9 cells/liter	Standard Deviation 1.2728
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood lymphocytes, Day 3 (48 hour),n=26, 26, 26	0.015 10^9 cells/liter	Standard Deviation 0.3081
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood lymphocytes, Follow-up, n=8, 9, 9	-0.100 10^9 cells/liter	Standard Deviation 0.4444
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood monocytes, Day 3 (48 hour),n=26, 26, 26	-0.069 10^9 cells/liter	Standard Deviation 0.097
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood monocytes, Follow-up, n=8, 9, 9	0.033 10^9 cells/liter	Standard Deviation 0.1323
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood neutrophils, Follow-up, n=8, 9, 9	0.089 10^9 cells/liter	Standard Deviation 0.7976
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood platelets, Day 3 (48 hour),n=26, 26, 26	17.4 10^9 cells/liter	Standard Deviation 16.43
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood platelets, Follow-up, n=8, 9, 9	1.8 10^9 cells/liter	Standard Deviation 17.89
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood platelets, Day 3 (48 hour),n=26, 26, 26	14.5 10^9 cells/liter	Standard Deviation 17.85
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood monocytes, Follow-up, n=8, 9, 9	-0.056 10^9 cells/liter	Standard Deviation 0.0527
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood leukocytes, Day 3 (48 hour),n=26, 26, 26	-0.400 10^9 cells/liter	Standard Deviation 0.6675
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood eosinophils, Follow-up, n=8, 9, 9	0.033 10^9 cells/liter	Standard Deviation 0.1323
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood neutrophils, Day 3 (48 hour),n=26, 26, 26	-0.288 10^9 cells/liter	Standard Deviation 0.4702
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood eosinophils, Day 3 (48 hour), n=26, 26, 26	0.004 10^9 cells/liter	Standard Deviation 0.0958
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood basophils, Day 3 (48 hour), n=26, 26, 26	-0.004 10^9 cells/liter	Standard Deviation 0.0344
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood neutrophils, Follow-up, n=8, 9, 9	-0.356 10^9 cells/liter	Standard Deviation 0.4187
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood basophils, Follow-up, n=8, 9, 9	0.000 10^9 cells/liter	Standard Deviation 0
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood lymphocytes, Follow-up, n=8, 9, 9	0.011 10^9 cells/liter	Standard Deviation 0.2147
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood lymphocytes, Day 3 (48 hour),n=26, 26, 26	-0.008 10^9 cells/liter	Standard Deviation 0.4127
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood platelets, Follow-up, n=8, 9, 9	9.8 10^9 cells/liter	Standard Deviation 26.48
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood monocytes, Day 3 (48 hour),n=26, 26, 26	-0.096 10^9 cells/liter	Standard Deviation 0.0871
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a	Blood leukocytes, Follow-up, n=8, 9, 9	-0.400 10^9 cells/liter	Standard Deviation 0.3841

Secondary

Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1b

Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2

Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood basophils, Day 3 (48 hour)	0.002 10^9 cells/liter	Standard Deviation 0.0092
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood basophils, Follow-up	NA 10^9 cells/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood eosinophils, Day 3 (48 hour)	0.036 10^9 cells/liter	Standard Deviation 0.0626
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood eosinophils, Follow-up	NA 10^9 cells/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood leukocytes, Day 3 (48 hour)	0.129 10^9 cells/liter	Standard Deviation 0.7779
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood leukocytes, Follow-up	NA 10^9 cells/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood lymphocytes, Day 3 (48 hour)	0.222 10^9 cells/liter	Standard Deviation 0.1707
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood lymphocytes, Follow-up	NA 10^9 cells/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood monocytes, Day 3 (48 hour)	-0.020 10^9 cells/liter	Standard Deviation 0.0651
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood monocytes, Follow-up	NA 10^9 cells/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood neutrophils, Day 3 (48 hour)	-0.112 10^9 cells/liter	Standard Deviation 0.6906
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood neutrophils, Follow-up	NA 10^9 cells/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood platelets, Day 3 (48 hour)	-7.4 10^9 cells/liter	Standard Deviation 38.14
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood platelets, Follow-up	NA 10^9 cells/liter	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood neutrophils, Day 3 (48 hour)	-0.251 10^9 cells/liter	Standard Deviation 0.6701
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood basophils, Day 3 (48 hour)	0.009 10^9 cells/liter	Standard Deviation 0.0129
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood lymphocytes, Follow-up	-0.038 10^9 cells/liter	Standard Deviation 0.2875
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood basophils, Follow-up	0.004 10^9 cells/liter	Standard Deviation 0.0097
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood platelets, Day 3 (48 hour)	-0.6 10^9 cells/liter	Standard Deviation 33.37
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood eosinophils, Day 3 (48 hour)	0.052 10^9 cells/liter	Standard Deviation 0.0839
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood monocytes, Day 3 (48 hour)	-0.013 10^9 cells/liter	Standard Deviation 0.0732
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood eosinophils, Follow-up	0.021 10^9 cells/liter	Standard Deviation 0.0671
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood neutrophils, Follow-up	-0.213 10^9 cells/liter	Standard Deviation 0.8126
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood leukocytes, Day 3 (48 hour)	0.039 10^9 cells/liter	Standard Deviation 0.8843
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood monocytes, Follow-up	0.045 10^9 cells/liter	Standard Deviation 0.0546
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood leukocytes, Follow-up	-0.183 10^9 cells/liter	Standard Deviation 0.7906
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood platelets, Follow-up	2.1 10^9 cells/liter	Standard Deviation 31.49
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2	Blood lymphocytes, Day 3 (48 hour)	0.243 10^9 cells/liter	Standard Deviation 0.2165

Secondary

Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3

Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Period 1, Day 3 (48 hour),n=10,0,0,2	0.581 10^9 cells/liter	Standard Deviation 0.6524
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Period 1, Day 3 (48 hour),n=10,0,0,2	-4.7 10^9 cells/liter	Standard Deviation 13.19
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Period 1, Day 3 (48 hour),n=10,0,0,2,	0.022 10^9 cells/liter	Standard Deviation 0.0598
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Period 1,Day 3 (48 hour),n=10,0,0,2	0.209 10^9 cells/liter	Standard Deviation 0.2885
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Period 1,Day 3 (48 hour),n=10,0,0,2	0.292 10^9 cells/liter	Standard Deviation 0.8198
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Period 1, Day 3 (48 hour),n=10,0,0,2	0.053 10^9 cells/liter	Standard Deviation 0.0254
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Period 1, Day 3 (48 hour), n=10,0,0,2	0.004 10^9 cells/liter	Standard Deviation 0.0158
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Period 2,Day 3 (48 hour),n=0,10,0,2	0.489 10^9 cells/liter	Standard Deviation 0.7302
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Period 2, Day 3 (48 hour), n=0,10,0,2,	0.009 10^9 cells/liter	Standard Deviation 0.012
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Period 2, Day 3 (48 hour),n=0,10,0,2	0.010 10^9 cells/liter	Standard Deviation 0.0615
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Period 2, Day 3 (48 hour),n=0,10,0,2	0.730 10^9 cells/liter	Standard Deviation 0.8427
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Period 2,Day 3 (48 hour), n=0,10,0,2	0.068 10^9 cells/liter	Standard Deviation 0.0421
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Period 2, Day 3 (48 hour),n=0,10,0,2	-22.2 10^9 cells/liter	Standard Deviation 41.82
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Period 2,Day 3 (48 hour),n=0,10,0,2	0.144 10^9 cells/liter	Standard Deviation 0.3405
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Period 3,Day 3 (48 hour),n=0,0,9,2	-0.009 10^9 cells/liter	Standard Deviation 0.3207
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Follow-up, n=0,0,9,2	0.132 10^9 cells/liter	Standard Deviation 0.849
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Period 3,Day 3 (48 hour),n=0,0,9,2	0.850 10^9 cells/liter	Standard Deviation 0.8456
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Period 3,Day 3 (48 hour), n=0,0,9,2	0.053 10^9 cells/liter	Standard Deviation 0.0487
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Follow-up, n=0,0,9,2	0.184 10^9 cells/liter	Standard Deviation 0.8251
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Follow-up, n=0,0,9,2	-0.002 10^9 cells/liter	Standard Deviation 0.0452
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Period 3, Day 3 (48 hour),n=0,0,9,2	0.042 10^9 cells/liter	Standard Deviation 0.0427
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Period 3, Day 3 (48 hour), n=0,0,9,2	0.009 10^9 cells/liter	Standard Deviation 0.0162
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Follow-up, n=0,0,9,2	2.4 10^9 cells/liter	Standard Deviation 21.93
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Follow-up, n=0,0, 9, 2	-0.089 10^9 cells/liter	Standard Deviation 0.1928
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Period 3, Day 3 (48 hour),n=0,0,9,2	-6.0 10^9 cells/liter	Standard Deviation 19.8
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Follow-up, n=0,0,9,2	0.022 10^9 cells/liter	Standard Deviation 0.0192
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Period 3, Day 3 (48 hour),n=0,0,9,2	0.966 10^9 cells/liter	Standard Deviation 0.7001
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Follow-up, n=0,0,9,2	0.008 10^9 cells/liter	Standard Deviation 0.0186
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Follow-up, n=0,0,9,2	4.0 10^9 cells/liter	Standard Deviation 8.49
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Period 1, Day 3 (48 hour), n=10,0,0,2	0.000 10^9 cells/liter	Standard Deviation 0.0141
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Period 2, Day 3 (48 hour), n=0,10,0,2,	-0.010 10^9 cells/liter	Standard Deviation 0.0141
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Period 3, Day 3 (48 hour), n=0,0,9,2	0.005 10^9 cells/liter	Standard Deviation 0.0071
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Basophils, Follow-up, n=0,0,9,2	0.015 10^9 cells/liter	Standard Deviation 0.0071
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Period 1, Day 3 (48 hour),n=10,0,0,2	0.060 10^9 cells/liter	Standard Deviation 0.0707
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Period 2,Day 3 (48 hour), n=0,10,0,2	0.055 10^9 cells/liter	Standard Deviation 0.0778
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Period 3,Day 3 (48 hour), n=0,0,9,2	0.040 10^9 cells/liter	Standard Deviation 0.099
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Eosinophils, Follow-up, n=0,0,9,2	0.045 10^9 cells/liter	Standard Deviation 0.1061
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Period 1, Day 3 (48 hour),n=10,0,0,2	-1.000 10^9 cells/liter	Standard Deviation 0.8202
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Period 2, Day 3 (48 hour),n=0,10,0,2	-1.415 10^9 cells/liter	Standard Deviation 1.0819
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Period 3, Day 3 (48 hour),n=0,0,9,2	-1.670 10^9 cells/liter	Standard Deviation 0.9475
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Leukocytes, Follow-up, n=0,0,9,2	-1.630 10^9 cells/liter	Standard Deviation 0.2121
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Period 1,Day 3 (48 hour),n=10,0,0,2	0.060 10^9 cells/liter	Standard Deviation 0.2263
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Period 2,Day 3 (48 hour),n=0,10,0,2	-0.035 10^9 cells/liter	Standard Deviation 0.2192
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Period 3,Day 3 (48 hour),n=0,0,9,2	-0.100 10^9 cells/liter	Standard Deviation 0.2404
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Lymphocytes, Follow-up, n=0,0, 9, 2	-0.050 10^9 cells/liter	Standard Deviation 0.0283
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Period 1, Day 3 (48 hour),n=10,0,0,2,	-0.025 10^9 cells/liter	Standard Deviation 0.0354
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Period 2, Day 3 (48 hour),n=0,10,0,2	-0.080 10^9 cells/liter	Standard Deviation 0.0424
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Period 3, Day 3 (48 hour),n=0,0,9,2	-0.110 10^9 cells/liter	Standard Deviation 0
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Monocytes, Follow-up, n=0,0,9,2	-0.100 10^9 cells/liter	Standard Deviation 0.0424
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Period 1,Day 3 (48 hour),n=10,0,0,2	-1.100 10^9 cells/liter	Standard Deviation 1.1597
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Period 2,Day 3 (48 hour),n=0,10,0,2	-1.350 10^9 cells/liter	Standard Deviation 0.891
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Period 3,Day 3 (48 hour),n=0,0,9,2	-1.505 10^9 cells/liter	Standard Deviation 0.799
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Neutrophils, Follow-up, n=0,0,9,2	-1.545 10^9 cells/liter	Standard Deviation 0.3606
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Period 1, Day 3 (48 hour),n=10,0,0,2	-10.5 10^9 cells/liter	Standard Deviation 10.61
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Period 2, Day 3 (48 hour),n=0,10,0,2	-5.0 10^9 cells/liter	Standard Deviation 5.66
Placebo	Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3	Platelets, Period 3, Day 3 (48 hour),n=0,0,9,2	-15.0 10^9 cells/liter	Standard Deviation 8.49

Secondary

Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 1b

Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3

Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Period 1, Day 3 (48 hour), n=10,0,0,2	-2.9 grams/liter	Standard Deviation 5.67
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Period 1,Day 3 (48 hour), n=10,0,0,2	-1.4 grams/liter	Standard Deviation 6.7
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Period 2, Day 3 (48 hour), n=0,10,0,2	-3.4 grams/liter	Standard Deviation 9.35
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Period 2, Day 3 (48 hour), n=0,10,0,2	-3.2 grams/liter	Standard Deviation 3.49
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Follow-up, n=0,0,9,2	-1.2 grams/liter	Standard Deviation 4.94
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Period 3,Day 3 (48 hour), n=0,0,9,2	-2.1 grams/liter	Standard Deviation 6.47
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Period 3, Day 3 (48 hour), n=0,0,9,2	-5.3 grams/liter	Standard Deviation 5.22
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Follow-up, n=0,0,9,2	-6.0 grams/liter	Standard Deviation 7.62
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Period 2, Day 3 (48 hour), n=0,10,0,2	-11.5 grams/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Period 3,Day 3 (48 hour), n=0,0,9,2	-10.5 grams/liter	Standard Deviation 0.71
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Period 1, Day 3 (48 hour), n=10,0,0,2	-2.0 grams/liter	Standard Deviation 9.9
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Period 2, Day 3 (48 hour), n=0,10,0,2	-1.5 grams/liter	Standard Deviation 4.95
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Period 3, Day 3 (48 hour), n=0,0,9,2	-6.5 grams/liter	Standard Deviation 2.12
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Ery. MCHC, Follow-up, n=0,0,9,2	0.0 grams/liter	Standard Deviation 0
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Follow-up, n=0,0,9,2	-6.5 grams/liter	Standard Deviation 7.78
Placebo	Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3	Hemoglobin, Period 1,Day 3 (48 hour), n=10,0,0,2	-7.5 grams/liter	Standard Deviation 0.71

Secondary

Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a

Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood Ery. MCHC, Day 3 (48 hour), n=26, 26, 26	0.4 grams/liter	Standard Deviation 4.78
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood Ery. MCHC, Follow-up, n=8, 9, 9	2.5 grams/liter	Standard Deviation 6.63
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood hemoglobin, Day 3 (48 hour), n=26, 26, 26	8.0 grams/liter	Standard Deviation 7.21
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood hemoglobin, Follow-up, n=8, 9, 9	-3.8 grams/liter	Standard Deviation 6.45
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood hemoglobin, Follow-up, n=8, 9, 9	-4.4 grams/liter	Standard Deviation 6.29
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood Ery. MCHC, Day 3 (48 hour), n=26, 26, 26	0.9 grams/liter	Standard Deviation 4.27
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood hemoglobin, Day 3 (48 hour), n=26, 26, 26	8.5 grams/liter	Standard Deviation 6.59
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood Ery. MCHC, Follow-up, n=8, 9, 9	4.1 grams/liter	Standard Deviation 3.33
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood hemoglobin, Follow-up, n=8, 9, 9	-2.3 grams/liter	Standard Deviation 8.03
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood Ery. MCHC, Follow-up, n=8, 9, 9	3.0 grams/liter	Standard Deviation 5.52
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood hemoglobin, Day 3 (48 hour), n=26, 26, 26	8.4 grams/liter	Standard Deviation 7.26
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a	Blood Ery. MCHC, Day 3 (48 hour), n=26, 26, 26	0.4 grams/liter	Standard Deviation 5.56

Secondary

Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2

Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood Ery. MCHC, Day 3 (48 hour)	-6.6 grams/liter	Standard Deviation 4.35
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood Ery. MCHC, Follow-up	NA grams/liter	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood hemoglobin, Day 3 (48 hour)	2.8 grams/liter	Standard Deviation 9.43
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood hemoglobin, Follow-up	NA grams/liter	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood hemoglobin, Follow-up	-5.9 grams/liter	Standard Deviation 3.67
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood Ery. MCHC, Day 3 (48 hour)	-6.6 grams/liter	Standard Deviation 3.2
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood hemoglobin, Day 3 (48 hour)	0.9 grams/liter	Standard Deviation 5.55
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2	Blood Ery. MCHC, Follow-up	-6.2 grams/liter	Standard Deviation 5.87

Secondary

Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a

Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 1 (2 hours), n=26, 26, 26,	-0.7 beats/minute	Standard Deviation 7.59
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 2 (24 hours), n=26, 26, 26	-0.7 beats/minute	Standard Deviation 7.11
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 3 (48 hours), n=26, 26, 26	-0.2 beats/minute	Standard Deviation 8.18
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Follow-up, n=8,9,9	-0.1 beats/minute	Standard Deviation 3.04
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Follow-up, n=8,9,9	0.2 beats/minute	Standard Deviation 7.56
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 1 (2 hours), n=26, 26, 26,	0.0 beats/minute	Standard Deviation 4.61
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 3 (48 hours), n=26, 26, 26	-0.2 beats/minute	Standard Deviation 6.2
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 2 (24 hours), n=26, 26, 26	0.6 beats/minute	Standard Deviation 5.87
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Follow-up, n=8,9,9	5.7 beats/minute	Standard Deviation 5.15
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 2 (24 hours), n=26, 26, 26	1.7 beats/minute	Standard Deviation 3.82
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 3 (48 hours), n=26, 26, 26	3.2 beats/minute	Standard Deviation 5.46
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a	Heart rate, Day 1 (2 hours), n=26, 26, 26,	1.7 beats/minute	Standard Deviation 3.61

Secondary

Change From Baseline in Vital Sign Parameter Heart Rate for Part 1b

Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Vital Sign Parameter Heart Rate for Part 2

Time frame: Baseline and up to 11 days

Population: Safety population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Day 1 (2 hours)	0.1 beats/minute	Standard Deviation 7.84
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Day 2 (24 hours)	-3.8 beats/minute	Standard Deviation 12.38
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Day 3 (48 hours)	-3.0 beats/minute	Standard Deviation 11.22
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Follow-up	NA beats/minute	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Follow-up	-0.3 beats/minute	Standard Deviation 9.06
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Day 1 (2 hours)	3.2 beats/minute	Standard Deviation 6.48
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Day 3 (48 hours)	3.4 beats/minute	Standard Deviation 6.29
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 2	Heart rate, Day 2 (24 hours)	-1.4 beats/minute	Standard Deviation 6.9

Secondary

Change From Baseline in Vital Sign Parameter Heart Rate for Part 3

Time frame: Baseline and up to 14 days

Population: Safety population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 1, Day 3 (48 hours), n=10,0,0,2	-3.2 beats/minute	Standard Deviation 8.27
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 1, Day 1 (2 hours), n=10,0,0,2	1.6 beats/minute	Standard Deviation 8.88
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 2 (24 hours), n=10,0,0,2	0.1 beats/minute	Standard Deviation 7.37
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 3 (48 hours), n=0,10,0,2	3.0 beats/minute	Standard Deviation 4.35
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 1 (2 hours), n=0,10,0,2	4.9 beats/minute	Standard Deviation 6.47
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 2 (24 hours), n=0,10,0,2	0.9 beats/minute	Standard Deviation 4.89
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 3, Day 3 (48 hours), n=0,0,9,2	3.2 beats/minute	Standard Deviation 9.92
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 3, Day 2 (24 hours), n=0,0,9,2	1.1 beats/minute	Standard Deviation 6.27
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 3, Day 1 (2 hours), n=0,0,9,2	4.6 beats/minute	Standard Deviation 7.65
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Follow-up, n=0,0,9,2	-4.2 beats/minute	Standard Deviation 8.83
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 1, Day 1 (2 hours), n=10,0,0,2	1.0 beats/minute	Standard Deviation 15.56
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 3 (48 hours), n=0,10,0,2	-2.5 beats/minute	Standard Deviation 0.71
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 3, Day 1 (2 hours), n=0,0,9,2	7.0 beats/minute	Standard Deviation 11.31
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 3, Day 2 (24 hours), n=0,0,9,2	0.5 beats/minute	Standard Deviation 3.54
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 3, Day 3 (48 hours), n=0,0,9,2	6.5 beats/minute	Standard Deviation 12.02
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 2 (24 hours), n=10,0,0,2	-4.5 beats/minute	Standard Deviation 16.26
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 1, Day 3 (48 hours), n=10,0,0,2	-4.0 beats/minute	Standard Deviation 15.56
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 1 (2 hours), n=0,10,0,2	5.0 beats/minute	Standard Deviation 8.49
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Follow-up, n=0,0,9,2	0.5 beats/minute	Standard Deviation 0.71
Placebo	Change From Baseline in Vital Sign Parameter Heart Rate for Part 3	Heart rate, Period 2, Day 2 (24 hours), n=0,10,0,2	2.0 beats/minute	Standard Deviation 7.07

Secondary

Change From Baseline in Vital Sign Parameters SBP and DBP for Part 1b

Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Baseline and up to 11 days

Secondary

Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2

Time frame: Baseline and up to 11 days

Population: Safety population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Day 1 (2 hours)	-8.4 millimeters of mercury	Standard Deviation 15.78
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Day 2 (24 hours)	-9.6 millimeters of mercury	Standard Deviation 13.55
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Day 3 (48 hours)	-4.1 millimeters of mercury	Standard Deviation 17.99
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Follow-up	NA millimeters of mercury	—
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Day 1 (2 hours)	-6.7 millimeters of mercury	Standard Deviation 6.13
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Day 2 (24 hours)	-5.4 millimeters of mercury	Standard Deviation 8.72
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Day 3 (48 hours)	-1.9 millimeters of mercury	Standard Deviation 7.98
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Follow-up	NA millimeters of mercury	—
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Follow-up	-0.1 millimeters of mercury	Standard Deviation 11.35
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Day 1 (2 hours)	6.7 millimeters of mercury	Standard Deviation 10.49
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Day 1 (2 hours)	-0.3 millimeters of mercury	Standard Deviation 6.95
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Day 2 (24 hours)	-3.1 millimeters of mercury	Standard Deviation 12.9
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Day 3 (48 hours)	-1.7 millimeters of mercury	Standard Deviation 6.62
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Day 3 (48 hours)	-4.2 millimeters of mercury	Standard Deviation 11.03
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	DBP, Day 2 (24 hours)	-3.5 millimeters of mercury	Standard Deviation 6.92
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2	SBP, Follow-up	-2.0 millimeters of mercury	Standard Deviation 17.81

Secondary

Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3

Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.

Time frame: Baseline and up to 14 days

Population: Safety population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 1, Day 1 (2 hours), n=10,0,0,2	4.6 millimeters of mercury	Standard Deviation 10.94
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 1, Day 2 (24 hours), n=10,0,0,2	-4.3 millimeters of mercury	Standard Deviation 11.13
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 1, Day 3 (48 hours), n=10,0,0,2	-4.8 millimeters of mercury	Standard Deviation 8.63
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 1, Day 1 (2 hours), n=10,0,0,2	3.4 millimeters of mercury	Standard Deviation 9.63
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 1, Day 2 (24 hours), n=10,0,0,2	-4.4 millimeters of mercury	Standard Deviation 7.56
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 1, Day 3 (48 hours), n=10,0,0,2	-3.7 millimeters of mercury	Standard Deviation 7.73
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 2, Day 1 (2 hours), n=0,10,0,2	-3.4 millimeters of mercury	Standard Deviation 7.73
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 2, Day 3 (48 hours), n=0,10,0,2	1.2 millimeters of mercury	Standard Deviation 9.37
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 2, Day 2 (24 hours), n=0,10,0,2	-2.6 millimeters of mercury	Standard Deviation 8.97
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 2, Day 3 (48 hours), n=0,10,0,2	0.7 millimeters of mercury	Standard Deviation 8.81
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 2, Day 2 (24 hours), n=0,10,0,2	-2.0 millimeters of mercury	Standard Deviation 9.71
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 2, Day 1 (2 hours), n=0,10,0,2	3.5 millimeters of mercury	Standard Deviation 11.18
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 3, Day 1 (2 hours), n=0,0,9,2	-2.8 millimeters of mercury	Standard Deviation 13.58
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Follow-up, n=0,0,9,2	2.2 millimeters of mercury	Standard Deviation 9.8
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 3, Day 2 (24 hours), n=0,0,9,2	-3.2 millimeters of mercury	Standard Deviation 3.96
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 3, Day 3 (48 hours), n=0,0,9,2	-0.7 millimeters of mercury	Standard Deviation 10.65
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 3, Day 1 (2 hours), n=0,0,9,2	7.4 millimeters of mercury	Standard Deviation 12.89
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 3, Day 2 (24 hours), n=0,0,9,2	4.1 millimeters of mercury	Standard Deviation 8.19
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Follow-up, n=0,0,9,2	5.1 millimeters of mercury	Standard Deviation 7.42
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 3, Day 3 (48 hours), n=0,0,9,2	-1.3 millimeters of mercury	Standard Deviation 9.34
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 2, Day 2 (24 hours), n=0,10,0,2	-4.0 millimeters of mercury	Standard Deviation 0
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 2, Day 3 (48 hours), n=0,10,0,2	-4.5 millimeters of mercury	Standard Deviation 0.71
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 3, Day 1 (2 hours), n=0,0,9,2	4.0 millimeters of mercury	Standard Deviation 9.9
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 1, Day 1 (2 hours), n=10,0,0,2	6.0 millimeters of mercury	Standard Deviation 7.07
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 3, Day 2 (24 hours), n=0,0,9,2	4.0 millimeters of mercury	Standard Deviation 0
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 1, Day 2 (24 hours), n=10,0,0,2	0.5 millimeters of mercury	Standard Deviation 3.54
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 1, Day 3 (48 hours), n=10,0,0,2	-1.5 millimeters of mercury	Standard Deviation 0.71
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 2, Day 1 (2 hours), n=0,10,0,2	10.5 millimeters of mercury	Standard Deviation 6.36
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 2, Day 2 (24 hours), n=0,10,0,2	6.0 millimeters of mercury	Standard Deviation 7.07
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 2, Day 3 (48 hours), n=0,10,0,2	-3.5 millimeters of mercury	Standard Deviation 4.95
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 3, Day 1 (2 hours), n=0,0,9,2	-1.0 millimeters of mercury	Standard Deviation 1.41
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 3, Day 2 (24 hours), n=0,0,9,2	-0.5 millimeters of mercury	Standard Deviation 2.12
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Period 3, Day 3 (48 hours), n=0,0,9,2	0.0 millimeters of mercury	Standard Deviation 12.73
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	SBP, Follow-up, n=0,0,9,2	-4.5 millimeters of mercury	Standard Deviation 3.54
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 3, Day 3 (48 hours), n=0,0,9,2	3.0 millimeters of mercury	Standard Deviation 5.66
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 1, Day 1 (2 hours), n=10,0,0,2	5.0 millimeters of mercury	Standard Deviation 8.49
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 1, Day 2 (24 hours), n=10,0,0,2	0.0 millimeters of mercury	Standard Deviation 7.07
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Follow-up, n=0,0,9,2	2.5 millimeters of mercury	Standard Deviation 3.54
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 1, Day 3 (48 hours), n=10,0,0,2	2.0 millimeters of mercury	Standard Deviation 2.83
Placebo	Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3	DBP, Period 2, Day 1 (2 hours), n=0,10,0,2	-4.5 millimeters of mercury	Standard Deviation 0.71

Secondary

Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a

Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).

Time frame: Baseline and up to 14 days

Population: Safety population

Arm	Measure	Group	Value (MEAN)	Dispersion
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 1 (2 hours), n=26, 26, 26,	1.8 millimeters of mercury	Standard Deviation 6.88
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 2 (24 hours), n=26, 26, 26	0.1 millimeters of mercury	Standard Deviation 6.82
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 3 (48 hours), n=26, 26, 26	5.3 millimeters of mercury	Standard Deviation 7.93
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Follow-up, n=8,9,9	18.0 millimeters of mercury	Standard Deviation 11.28
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 1 (2 hours), n=26, 26, 26,	3.2 millimeters of mercury	Standard Deviation 7.04
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 3 (48 hours), n=26, 26, 26	2.2 millimeters of mercury	Standard Deviation 7.65
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 2 (24 hours), n=26, 26, 26	2.3 millimeters of mercury	Standard Deviation 8.11
Gepotidacin 1500 mg - R Capsules	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Follow-up, n=8,9,9	8.3 millimeters of mercury	Standard Deviation 7.36
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 3 (48 hours), n=26, 26, 26	-1.3 millimeters of mercury	Standard Deviation 7.12
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 3 (48 hours), n=26, 26, 26	2.8 millimeters of mercury	Standard Deviation 6.29
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Follow-up, n=8,9,9	9.4 millimeters of mercury	Standard Deviation 6.09
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 1 (2 hours), n=26, 26, 26,	1.0 millimeters of mercury	Standard Deviation 5.59
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Follow-up, n=8,9,9	6.4 millimeters of mercury	Standard Deviation 5.73
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 1 (2 hours), n=26, 26, 26,	-1.3 millimeters of mercury	Standard Deviation 7.24
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 2 (24 hours), n=26, 26, 26	-0.4 millimeters of mercury	Standard Deviation 7.41
Gepotidacin 1500 mg RC Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 2 (24 hours), n=26, 26, 26	-2.8 millimeters of mercury	Standard Deviation 10.21
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 3 (48 hours), n=26, 26, 26	-0.2 millimeters of mercury	Standard Deviation 6.46
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 2 (24 hours), n=26, 26, 26	-1.8 millimeters of mercury	Standard Deviation 5.31
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Day 1 (2 hours), n=26, 26, 26,	1.1 millimeters of mercury	Standard Deviation 5.25
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	SBP, Follow-up, n=8,9,9	6.9 millimeters of mercury	Standard Deviation 7.83
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 3 (48 hours), n=26, 26, 26	1.0 millimeters of mercury	Standard Deviation 7.19
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 2 (24 hours), n=26, 26, 26	0.0 millimeters of mercury	Standard Deviation 6.87
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Day 1 (2 hours), n=26, 26, 26,	2.2 millimeters of mercury	Standard Deviation 6.34
Gepotidacin 1500 mg HSWG Tablets	Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a	DBP, Follow-up, n=8,9,9	7.4 millimeters of mercury	Standard Deviation 4.85

Secondary

Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a

Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 1a. Only categories with significant values have been presented.

Time frame: Up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Ketones, Day 3 (48 hours), 1+	1 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 5+	4 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 6+	18 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 7+	3 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 8+	1 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 5+	2 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 6+	5 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 7+	1 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Specific gravity, Day 3 (48 hours), 1+	26 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Specific gravity, Follow-up, 1+	8 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Specific gravity, Day 3 (48 hours), 1+	26 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Ketones, Day 3 (48 hours), 1+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 5+	4 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 8+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 5+	4 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Specific gravity, Follow-up, 1+	9 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 7+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 6+	16 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 6+	5 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 7+	6 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 7+	2 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 7+	8 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 8+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 5+	3 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Specific gravity, Day 3 (48 hours), 1+	26 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Follow-up, 6+	4 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Ketones, Day 3 (48 hours), 1+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine Specific gravity, Follow-up, 1+	9 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 5+	4 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a	Urine pH, Day 3 (48 hours), 6+	14 Participants

Secondary

Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1b

Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Up to 11 days

Secondary

Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2

Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 4+ 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 2. Only categories with significant values have been presented.

Time frame: Baseline and up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Occult blood, Trace, Day 3 (48 hours),	2 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 8+	1 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 5+	2 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Follow-up, 5+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Occult blood, Day 3 (48 hours), 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Follow-up, 6+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 6+	6 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Follow-up, 8+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Occult blood, Follow-up, 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Specific gravity, Day 3 (48 hours), 1+	10 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 7+	1 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Specific gravity, Follow-up, 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Ketones, Follow-up, Trace	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Specific gravity, Follow-up, 1+	10 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Ketones, Follow-up, Trace	1 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Occult blood, Day 3 (48 hours), 1+	1 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Occult blood, Trace, Day 3 (48 hours),	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Occult blood, Follow-up, 1+	1 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 5+	7 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 6+	2 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 7+	1 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Day 3 (48 hours), 8+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Follow-up, 5+	3 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Follow-up, 6+	6 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine pH, Follow-up, 8+	1 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2	Urine Specific gravity, Day 3 (48 hours), 1+	10 Participants

Secondary

Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3

Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 3. Only categories with significant values have been presented.

Time frame: Up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 5+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 8+	1 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 3,Day 3 (48hours), 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period1,Day 3(48 hours),1+	10 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 7+	5 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 6+	4 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood, Follow-up, 4+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1 Day 3 (48 hours), 5+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity,Period 3,Day 3(48 hours),1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 7+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 6+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 3+	1 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Ketones, Follow-up, 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 5+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 7+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 2,Day 3 (48hours)	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 1, Day 3 (48hours)	2 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 6+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 5+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 2,Day 3 (48hours), 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Follow-up, 1+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 7+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 6+	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 3,Day 3 (48hours)	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period2,Day 3(48 hours),1+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 3+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Ketones, Follow-up, 1+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 1, Day 3 (48hours)	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 1+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 2,Day 3 (48hours)	1 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 2,Day 3 (48hours), 1+	1 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 3,Day 3 (48hours)	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 3,Day 3 (48hours), 1+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood, Follow-up, 4+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1 Day 3 (48 hours), 5+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 6+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 7+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 8+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 5+	6 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 6+	2 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 7+	2 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 5+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 6+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 7+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 5+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 6+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 7+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period1,Day 3(48 hours),1+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period2,Day 3(48 hours),1+	10 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity,Period 3,Day 3(48 hours),1+	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Follow-up, 1+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 3,Day 3 (48hours)	2 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 5+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 1, Day 3 (48hours)	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 6+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 2,Day 3 (48hours), 1+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 7+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period2,Day 3(48 hours),1+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 5+	3 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 2,Day 3 (48hours)	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 6+	5 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 7+	1 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 3+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Follow-up, 1+	9 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 5+	3 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity,Period 3,Day 3(48 hours),1+	9 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 6+	2 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 1+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 7+	4 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood, Follow-up, 4+	1 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1 Day 3 (48 hours), 5+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 6+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 3,Day 3 (48hours), 1+	1 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Ketones, Follow-up, 1+	1 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 7+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period1,Day 3(48 hours),1+	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 8+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1 Day 3 (48 hours), 5+	1 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period1,Day 3(48 hours),1+	2 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 5+	1 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 5+	2 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 2,Day 3 (48hours), 1+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 1+	1 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 3,Day 3 (48hours), 1+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 6+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 1, Day 3 (48hours)	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Follow-up, 1+	2 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 6+	1 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 2, Day 3 (48 hours), 7+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 2,Day 3 (48hours)	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 8+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity,Period 3,Day 3(48 hours),1+	2 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 5+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 6+	1 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Specific gravity, Period2,Day 3(48 hours),1+	2 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood, Follow-up, 4+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 6+	2 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Period 1,Day 3 (48hours), 3+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Ketones, Follow-up, 1+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 1, Day 3 (48 hours), 7+	1 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Period 3, Day 3 (48 hours), 7+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine pH, Follow-up, 7+	0 Participants
Placebo	Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3	Urine Occult blood,Trace,Period 3,Day 3 (48hours)	0 Participants

Secondary

Number of Participants With AEs and SAEs for Part 1b

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.

Time frame: Up to 11 days

Secondary

Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Participants with non-serious AEs and SAEs has been reported. Safety Population comprised of all participants who received at least 1 dose of study medication and had at least 1 post dose safety assessment.

Time frame: Up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Gepotidacin 1500 mg - R Capsules	Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a	Non serious AE	8 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a	SAE	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a	Non serious AE	5 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a	SAE	0 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a	Non serious AE	9 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a	SAE	0 Participants

Secondary

Number of Participants With Non-serious AEs and SAEs for Part 2

Time frame: Up to 11 days

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Gepotidacin 1500 mg - R Capsules	Number of Participants With Non-serious AEs and SAEs for Part 2	Non serious AE	6 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Non-serious AEs and SAEs for Part 2	SAE	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Non-serious AEs and SAEs for Part 2	Non serious AE	9 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Non-serious AEs and SAEs for Part 2	SAE	0 Participants

Secondary

Number of Participants With Non-serious AEs and SAEs for Part 3

Time frame: Up to 14 days

Population: Safety Population

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Gepotidacin 1500 mg - R Capsules	Number of Participants With Non-serious AEs and SAEs for Part 3	Non seriou AE	0 Participants
Gepotidacin 1500 mg - R Capsules	Number of Participants With Non-serious AEs and SAEs for Part 3	SAE	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Non-serious AEs and SAEs for Part 3	SAE	0 Participants
Gepotidacin 1500 mg RC Tablets	Number of Participants With Non-serious AEs and SAEs for Part 3	Non seriou AE	1 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Non-serious AEs and SAEs for Part 3	Non seriou AE	6 Participants
Gepotidacin 1500 mg HSWG Tablets	Number of Participants With Non-serious AEs and SAEs for Part 3	SAE	0 Participants
Placebo	Number of Participants With Non-serious AEs and SAEs for Part 3	Non seriou AE	0 Participants
Placebo	Number of Participants With Non-serious AEs and SAEs for Part 3	SAE	0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026

To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Ae (t1-t2) for Part 2

Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a

Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a

Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a

Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a

Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a

Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a

AUC (0-12) for Part 2

AUC (0-24) for Part 2

AUC (0-48) for Part 2

AUC (0-infinity) of Plasma Gepotidacin for Part 1b

AUC (0-infinity) of Plasma Gepotidacin for Part 2

AUC (0-infinity) of Plasma Gepotidacin for Part 3

AUC (0-t) of Plasma Gepotidacin for Part 1b

AUC (0-t) of Plasma Gepotidacin for Part 2

AUC (0-t) of Plasma Gepotidacin for Part 3

CLr for Part 2

CLr for Part 3

Cmax of Plasma Gepotidacin for Part 1b

Cmax of Plasma Gepotidacin for Part 2

Cmax of Plasma Gepotidacin for Part 3

fe% for Part 2

fe% for Part 3

Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a

Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a

Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a

Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a

Renal Clearance of Drug in Urine (CLr) for Part 1a

t1/2 of Plasma Gepotidacin for Part 1b

t1/2 of Plasma Gepotidacin for Part 2

t1/2 of Plasma Gepotidacin for Part 3

Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a

Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a

Tlag of Plasma Gepotidacin for Part 1b

Tlag of Plasma Gepotidacin for Part 2

Tlag of Plasma Gepotidacin for Part 3

Tmax of Plasma Gepotidacin for Part 1b

Tmax of Plasma Gepotidacin for Part 2

Tmax of Plasma Gepotidacin for Part 3

Total Unchanged Drug (Ae Total) for Part 2

Total Unchanged Drug (Ae Total) for Part 3

Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a

Urine Ae (t1-t2) for Part 3

Urine AUC (0-12) for Part 3

Urine AUC (0-24) for Part 3

Urine AUC (0-48) for Part 3

Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2

Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1b

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2

Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3

Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 1b

Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3

Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2

Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3

Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a