Trial Outcomes & Findings for Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function (NCT NCT02729038)

Results Overview

AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity . Blood samples were collected at the indicated time-points, during the study. The Pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. The PK Population consisted of all participant's, who received at least 1 dose of gepotidacin and had evaluable PK data.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.

Results posted on

2020-07-21

Participant Flow

A 2-part study, conducted in participant's with varying degree of renal impairment (RI) which enrolled 32 participants, wherein, 24 participants were enrolled in Part 1 and 8 participants in Part 2. The study was conducted, at 3 centers in United States of America from 29 June 2016 to 20 June 2017.

A total of 43 participants were screened of which 8 were screen-failures and 32 were enrolled in the study and 3 participants were reserve participants and were no longer required in the study .

Participant milestones

Participant milestones
Measure	Normal, Part 1 The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated creatinine clearance (Clcr) \>= 90 milliliter per minute), in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	ESRD on Hemodialysis, Part 2 The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in this period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
Part 1 (Up to 44 Days) STARTED	8	8	8	0
Part 1 (Up to 44 Days) COMPLETED	8	8	8	0
Part 1 (Up to 44 Days) NOT COMPLETED	0	0	0	0
Part 2 (Up to 50 Days) STARTED	0	0	0	8
Part 2 (Up to 50 Days) COMPLETED	0	0	0	8
Part 2 (Up to 50 Days) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	ESRD on Hemodialysis, Part 2 n=8 Participants The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in this period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (Period 1) and gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).	Total n=32 Participants Total of all reporting groups
Age, Continuous	61.5 Years STANDARD_DEVIATION 10.78 • n=5 Participants	72.0 Years STANDARD_DEVIATION 7.05 • n=7 Participants	61.4 Years STANDARD_DEVIATION 12.49 • n=5 Participants	51.8 Years STANDARD_DEVIATION 7.09 • n=4 Participants	61.6 Years STANDARD_DEVIATION 2.72 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized White: White/Caucasian/European	7 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants
Race/Ethnicity, Customized Multiple: African American/African/White	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.

Population: PK Parameter Population.

AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity . Blood samples were collected at the indicated time-points, during the study. The Pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. The PK Population consisted of all participant's, who received at least 1 dose of gepotidacin and had evaluable PK data.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Area Under the Plasma Concentration Time Curve (AUC) From Hour 0 to Infinity (AUC[0-inf]) of Gepotidacin for Part 1	14838 Nanogram*hour per milliliter Geometric Coefficient of Variation 20.7	22367 Nanogram*hour per milliliter Geometric Coefficient of Variation 17.0	28545 Nanogram*hour per milliliter Geometric Coefficient of Variation 21.4

PRIMARY outcome

Timeframe: Pre-dose, 0.25 hours, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both.

Population: PK Parameter Population.

AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for gepotidacin. Blood samples were collected at the indicated time-points, during the study.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
AUC (0-inf) of Gepotidacin for Part 2	14838 Nanogram*hour per milliliter Geometric Coefficient of Variation 20.7	35239 Nanogram*hour per milliliter Geometric Coefficient of Variation 95.0	60461 Nanogram*hour per milliliter Geometric Coefficient of Variation 140.5

PRIMARY outcome

Timeframe: Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.

Population: PK Parameter Population.

Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Maximum Observed Plasma Concentration (Cmax) of Gepotidacin for Part 1	4498 nanogram per milliliter Geometric Coefficient of Variation 16.3	5306 nanogram per milliliter Geometric Coefficient of Variation 16.0	7084 nanogram per milliliter Geometric Coefficient of Variation 23.3

PRIMARY outcome

Timeframe: Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on during treatment period 1 and 2 both.

Population: PK Parameter Population

Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Cmax of Gepotidacin for Part 2	4498 nanogram per milliliter Geometric Coefficient of Variation 16.3	10123 nanogram per milliliter Geometric Coefficient of Variation 216.3	26839 nanogram per milliliter Geometric Coefficient of Variation 797.1

PRIMARY outcome

Timeframe: Pre-dose (0.0), 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 post-dose during the single treatment period

Population: PK Parameter Population.

Urine samples from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. No formal statistical analysis of group comparison was planned for urine PK parameters.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Total Amount Excreted in Urine (Ae Total), Part 1	280.49 milligram. Geometric Coefficient of Variation 15.2	165.86 milligram. Geometric Coefficient of Variation 39.4	59.40 milligram. Geometric Coefficient of Variation 68.3

PRIMARY outcome

Timeframe: Pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during both treatment period 1 and 2

Population: PK Parameter Population

Urine samples, from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. Urine samples were collected at pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=3 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=3 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Ae Total of Gepotidacin for Part 2	280.49 milligram Geometric Coefficient of Variation 15.2	7.87 milligram Geometric Coefficient of Variation 96.4	10.87 milligram Geometric Coefficient of Variation 64.7

PRIMARY outcome

Timeframe: At pre-dose (0.0), 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 post-dose during the single treatment period

Population: PK Parameter Population

The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Percentage of the Given Dose Excreted in Urine (fe%) of Gepotidacin for Part 1	37.40 Percentage of gepotidacin Geometric Coefficient of Variation 15.2	22.11 Percentage of gepotidacin Geometric Coefficient of Variation 39.4	7.92 Percentage of gepotidacin Geometric Coefficient of Variation 68.3

PRIMARY outcome

Timeframe: At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods

Population: PK Parameter Population

The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100. No formal statistical analysis of group comparison was planned for urine PK parameters. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=3 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=3 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
fe% of Gepotidacin for Part 2	37.40 Percentage of gepotidacin Geometric Coefficient of Variation 15.2	1.05 Percentage of gepotidacin Geometric Coefficient of Variation 96.4	1.45 Percentage of gepotidacin Geometric Coefficient of Variation 64.7

PRIMARY outcome

Timeframe: At pre-dose (0.0), 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 post-dose during the single treatment period

Population: PK Parameter Population

Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). The renal clearance was calculated by Ae total divided by AUC from hour 0 to the last measurable plasma concentration AUC (0-t). Urine samples were collected at pre-dose (0.0), 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 post-dose during the single treatment period. No formal statistical analysis of group comparison was planned for urine PK parameters.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Renal Clearance (CLr) of Gepotidacin for Part 1	19.24 Liter per hour Geometric Coefficient of Variation 18.8	7.58 Liter per hour Geometric Coefficient of Variation 44.3	2.13 Liter per hour Geometric Coefficient of Variation 84.3

PRIMARY outcome

Timeframe: At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods

Population: PK Parameter Population

Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). Urine samples were collected at pre-dose (0.0), 0 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=3 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=3 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
CLr of Gepotidacin for Part 2	19.24 Liter per hour Geometric Coefficient of Variation 18.8	0.29 Liter per hour Geometric Coefficient of Variation 101.7	0.10 Liter per hour Geometric Coefficient of Variation 277.5

PRIMARY outcome

Timeframe: Dialysate fluid were to be collected on Day 1 after dosing (Period 1 only) at pre-dose from 0 to 4 hours

Population: PK parameter Population.

Partial area under the curve estimated from predialyzer samples collected from start of dialysis (t0) to end of dialysis (t1). Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm..

Outcome measures

Outcome measures
Measure	Normal, Part 1 The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
AUC (t0-t1) of Gepotidacin for Part 2	—	1062 Nanogram*hour per milliliter Geometric Coefficient of Variation 36.3	—

PRIMARY outcome

Timeframe: Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1

CLD measured the dialysis clearance of gepotidacin over the specified duration in the study and indicates how quickly gepotidacin is cleared out from blood or plasma. Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm.

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Dialysis Clearance (CLD) of Gepotidacin for Part 2	6.63 Liter per hour Geometric Coefficient of Variation 15.8	—	—

PRIMARY outcome

Timeframe: Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1

Population: PK Parameter Population

Dialysate samples were collected at specified time points in the study. Frem is defined as the fraction (dose in percentage) removed by the process of hemodialysis from 0 to 4 hours after the start of hemodialysis (or to the end of dialysis if less than 4 hours)

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Fraction (%) of the Dose Removed by Hemodialysis From 0 to 4 Hours After the Start of Hemodialysis (Frem%[0-4]) of Gepotidacin for Part 2	5.89 Percentage of gepotidacin removed Geometric Coefficient of Variation 26.2	—	—

SECONDARY outcome

Timeframe: Up to 16 Days

Population: The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment.

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific timepoints during the study. No formal analysis of group comparison was planned for dialysate PK parameters

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 2 - 24 hour, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 2 - 36 hour, Abnormal NCS	2 Participants	6 Participants	6 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Baseline, Abnormal, NCS	3 Participants	6 Participants	7 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Baseline, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1 - 1.5 hour, Abnormal, NCS	5 Participants	6 Participants	6 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1- 1.5 hour, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1- 2 hour, Abnormal, NCS	3 Participants	6 Participants	6 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1- 2 hour, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1 - 4 hour, Abnormal, NCS	2 Participants	6 Participants	7 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1- 4 hour, Abnormal CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1 - 8 hour, Abnormal NCS	2 Participants	6 Participants	6 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1 - 8 hour, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1 - 12 hour, Abnormal NCS	2 Participants	6 Participants	7 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 1 - 12 hour, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 2 - 24 hour, Abnormal NCS	3 Participants	7 Participants	5 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 2 - 36 hour, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day 3 - 48 hour, Abnormal NCS	2 Participants	6 Participants	5 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Day3 - 48 hour, Abnormal, CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Follow-up, Abnormal NCS	3 Participants	5 Participants	5 Participants
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1 Follow-up, Abnormal CS	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 23 Days

Population: Participants

Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific time points during the study. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates data was not available

Outcome measures

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1- Baseline, Abnormal CS (n=8,8)	0 Participants	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1 - Baseline, Abnormal NCS (n=8,8)	6 Participants	7 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1- 2 hour, Abnormal, NCS (n=8,0)	6 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1- 2 hour, Abnormal, CS (n=8,0)	0 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1 - 4 hour, Abnormal, NCS (n=8,0)	7 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1- 4 hour, Abnormal CS (n=8,0)	0 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1 - 8 hour, Abnormal NCS (n=8,0)	7 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1 - 8 hour, Abnormal, CS (n=8,0)	0 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1 - 12 hour, Abnormal NCS (n=8,0)	6 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 1 - 12 hour, Abnormal, CS (n=8,0)	0 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 2 - 24 hour, Abnormal NCS (n=8,0)	7 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 2 - 24 hour, Abnormal, CS (n=8,0)	0 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 2 - 36 hour, Abnormal NCS (n=8,0)	8 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 2 - 36 hour, Abnormal, CS (n=8,0)	0 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 3 - 48 hour, Abnormal NCS (n=8,0)	7 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day3 - 48 hour, Abnormal, CS (n=8,0)	0 Participants	—	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8- 2 hour, Abnormal, NCS (n=0,8)	—	8 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8- 2 hour, Abnormal, CS (n=0,8)	—	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8 - 4 hour, Abnormal, NCS (n=0,8)	—	8 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8- 4 hour, Abnormal CS (n=0,8)	—	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8 - 8 hour, Abnormal NCS (n=0,8)	—	7 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8 - 8 hour, Abnormal, CS (n=0,8)	—	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8 - 12 hour, Abnormal NCS (n=0,8)	—	8 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 8 - 12 hour, Abnormal, CS (n=0,8)	—	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 9- 24 hour, Abnormal, NCS (n=0,8)	—	6 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 9- 24 hour, Abnormal, CS (n=0,8)	—	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 9 - 36 hour, Abnormal, NCS (n=0,8)	—	8 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 9- 36 hour, Abnormal CS (n=0,8)	—	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 10 - 48 hour, Abnormal NCS (n=0,8)	—	7 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Day 10 - 48 hour, Abnormal, CS (n=0,8)	—	0 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Follow-up, Abnormal NCS (n=0,8)	—	6 Participants	—
Number of Participants With Abnormal 12-lead ECG Readings for Part 2 Follow-up, Abnormal CS (n=0,8)	—	0 Participants	—

SECONDARY outcome

Timeframe: Baseline and up to 16 Days

Population: Safety Population

Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was reported. Baseline was defined as the latest pre-dose assessment. Change from Baseline, was defined as post Baseline values minus the values at Baseline.

Outcome measures
Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) From Time 0 to 1 Hour After the Start of Hemodialysis (Arem[0-1]), Arem (1-2), Arem (2-3), Arem (3-4) for Part 2 Arem (0-1), (n=8)	18.22 milligram Geometric Coefficient of Variation 27.7	—	—
Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) From Time 0 to 1 Hour After the Start of Hemodialysis (Arem[0-1]), Arem (1-2), Arem (2-3), Arem (3-4) for Part 2 Arem (1-2), (n=8)	12.42 milligram Geometric Coefficient of Variation 34.8	—	—
Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) From Time 0 to 1 Hour After the Start of Hemodialysis (Arem[0-1]), Arem (1-2), Arem (2-3), Arem (3-4) for Part 2 Arem (2-3), (n=8)	8.93 milligram Geometric Coefficient of Variation 32.5	—	—
Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) From Time 0 to 1 Hour After the Start of Hemodialysis (Arem[0-1]), Arem (1-2), Arem (2-3), Arem (3-4) for Part 2 Arem (3-4), (n=6)	5.35 milligram Geometric Coefficient of Variation 36.6	—	—

Adverse Events

Normal, Part 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate, Part 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Severe/ESRD Not on Hemodialysis, Part 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ESRD on Hemodialysis (Before Hemodialysis)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

ESRD on Hemodialysis (After Hemodialysis)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Normal, Part 1 n=8 participants at risk The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 participants at risk The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 participants at risk The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	ESRD on Hemodialysis (Before Hemodialysis) n=8 participants at risk The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 1 on Day 1 and treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour infusion starting approximately 2 hours before the initiation of the last hemodialysis session of the week (treatment period 1).	ESRD on Hemodialysis (After Hemodialysis) n=8 participants at risk The participants in this arm, in the part 2 of the study participated in 2 treatment periods. The dosing in each period was separated by a wash-out period of 7-days. These participants, during treatment period 2 on Day 8, received a single dose of study drug gepotidacin 750 milligram, administered as a 2-hour intravenous infusion starting within 2 hours after completion of the last hemodialysis session of the week (treatment period 2).
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	25.0% 2/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	25.0% 2/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	25.0% 2/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	50.0% 4/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Gastrointestinal disorders Faeces soft	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Gastrointestinal disorders Nausea	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Nervous system disorders Dizziness postural	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Nervous system disorders Headache	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
General disorders Infusion site erythema	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Gastrointestinal disorders Flatulence	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	25.0% 2/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
General disorders Suprapubic pain	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Infections and infestations Lower respiratory tract infection	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	0.00% 0/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.	12.5% 1/8 • AEs and SAEs were collected from the start of study treatment upto 94 days AEs and SAEs were collected in Safety Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Normal, Part 1 n=8 Participants The eligible participants, with normal renal function (participants with estimated glomerular filtration rate (eGFR) \>= 90 milliliter per minute per 1.73 meter\^2 or estimated Clcr \>= 90 milliliter per minute, in this arm received a single dose of gepotidacin 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Moderate, Part 1 n=8 Participants The eligible participants, with moderate renal function (participants with eGFR in the range of 30 to 59 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.	Severe/ESRD Not on Hemodialysis, Part 1 n=8 Participants The eligible participants, with severe renal impairment and participants with ESRD not on hemodialysis renal function (participants with eGFR \< 30 milliliter per minute per 1.73 meter\^2), in this arm received a single dose of gepotidacin at 750 milligrams, administered as 2-hour intravenous infusion on Day 1.
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 3 - 48 hour	5.0 Milliliter of mercury Standard Deviation 7.69	0.6 Milliliter of mercury Standard Deviation 6.48	-5.3 Milliliter of mercury Standard Deviation 5.87
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 1- 1.5 hour,	3.1 Milliliter of mercury Standard Deviation 2.36	6.8 Milliliter of mercury Standard Deviation 11.94	-3.3 Milliliter of mercury Standard Deviation 13.77
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 1- 2 hour,	6.9 Milliliter of mercury Standard Deviation 12.54	8.3 Milliliter of mercury Standard Deviation 13.39	-4.4 Milliliter of mercury Standard Deviation 12.73
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 1 - 4 hour	-0.9 Milliliter of mercury Standard Deviation 12.15	3.4 Milliliter of mercury Standard Deviation 5.42	1.0 Milliliter of mercury Standard Deviation 13.03
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 1 - 8 hour,	1.3 Milliliter of mercury Standard Deviation 12.69	5.9 Milliliter of mercury Standard Deviation 7.30	6.0 Milliliter of mercury Standard Deviation 12.75
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 1 - 12 hour,	-3.4 Milliliter of mercury Standard Deviation 12.29	14.1 Milliliter of mercury Standard Deviation 12.89	4.6 Milliliter of mercury Standard Deviation 6.30
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 2 - 24 hour,	-1.1 Milliliter of mercury Standard Deviation 13.28	5.3 Milliliter of mercury Standard Deviation 6.65	-4.1 Milliliter of mercury Standard Deviation 11.46
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 2 - 36 hour	0.5 Milliliter of mercury Standard Deviation 3.74	14.4 Milliliter of mercury Standard Deviation 13.02	-0.4 Milliliter of mercury Standard Deviation 9.12
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Day 3 - 48 hour	-1.0 Milliliter of mercury Standard Deviation 10.72	7.8 Milliliter of mercury Standard Deviation 9.10	-6.0 Milliliter of mercury Standard Deviation 18.18
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 SBP, Follow-up	0.8 Milliliter of mercury Standard Deviation 3.28	8.3 Milliliter of mercury Standard Deviation 13.06	-4.8 Milliliter of mercury Standard Deviation 18.16
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 1- 1.5 hour	0.1 Milliliter of mercury Standard Deviation 3.91	-1.3 Milliliter of mercury Standard Deviation 3.92	-3.5 Milliliter of mercury Standard Deviation 7.19
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 1- 2 hour,	5.8 Milliliter of mercury Standard Deviation 7.15	1.3 Milliliter of mercury Standard Deviation 3.99	0.4 Milliliter of mercury Standard Deviation 4.07
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 1 - 4 hour	3.0 Milliliter of mercury Standard Deviation 5.50	-2.4 Milliliter of mercury Standard Deviation 8.14	1.5 Milliliter of mercury Standard Deviation 4.99
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 1 - 8 hour	4.9 Milliliter of mercury Standard Deviation 6.06	-4.3 Milliliter of mercury Standard Deviation 10.55	-2.4 Milliliter of mercury Standard Deviation 6.95
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 1 - 12 hour	2.9 Milliliter of mercury Standard Deviation 6.36	-0.5 Milliliter of mercury Standard Deviation 9.61	-3.6 Milliliter of mercury Standard Deviation 4.66
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 2 - 24 hour	2.3 Milliliter of mercury Standard Deviation 5.50	1.0 Milliliter of mercury Standard Deviation 5.55	-2.3 Milliliter of mercury Standard Deviation 4.17
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Day 2 - 36 hour	3.1 Milliliter of mercury Standard Deviation 8.22	-0.8 Milliliter of mercury Standard Deviation 13.07	-3.5 Milliliter of mercury Standard Deviation 3.96
Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1 DBP, Follow-up	2.6 Milliliter of mercury Standard Deviation 5.48	0.5 Milliliter of mercury Standard Deviation 11.60	-1.8 Milliliter of mercury Standard Deviation 6.58