Trial Outcomes & Findings for Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects (NCT NCT04079790)
NCT ID: NCT04079790
Last Updated: 2020-09-04
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose
Results posted on
2020-09-04
Participant Flow
This was a two-part, double-blind, randomized, sequential study to evaluate pharmacokinetics of Gepotidacin in healthy adult and adolescent participants. The study was conducted at a single center in the United States.
A total of 34 participants were randomized in this study (Randomized Population): 16 adult participants in Part 1 and 18 adolescent participants in Part 2.
Participant milestones
| Measure |
Gepotidacin (A/C/E)
Adult participants were randomized to receive a single dose of gepotidacin 1500 milligrams (mg) (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 12 hours (Treatment C) on Day 5 of Period 2, and two doses of gepotidacin 3000 mg separated by 6 hours (Treatment E) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
|
Placebo (B/D/F)
Adult participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 12 hours (Treatment D) on Day 5 of Period 2, and two doses of gepotidacin matching placebo separated by 6 hours (Treatment F) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
|
Gepotidacin (A/G)
Adolescent participants were randomized to receive a single dose of gepotidacin 1500 mg (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 6 hours (Treatment G) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
|
Placebo (B/H)
Adolescent participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 6 hours (Treatment H) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
|
|---|---|---|---|---|
|
Part 1, Period 1(Day 1 to Day 4)
STARTED
|
14
|
2
|
0
|
0
|
|
Part 1, Period 1(Day 1 to Day 4)
COMPLETED
|
13
|
2
|
0
|
0
|
|
Part 1, Period 1(Day 1 to Day 4)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Part 1, Period 2 (Day 5 to Day 8)
STARTED
|
13
|
2
|
0
|
0
|
|
Part 1, Period 2 (Day 5 to Day 8)
COMPLETED
|
13
|
2
|
0
|
0
|
|
Part 1, Period 2 (Day 5 to Day 8)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1, Period 3 (Day 9 to Day 11)
STARTED
|
13
|
2
|
0
|
0
|
|
Part 1, Period 3 (Day 9 to Day 11)
COMPLETED
|
13
|
2
|
0
|
0
|
|
Part 1, Period 3 (Day 9 to Day 11)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2, Period 1 (Day 1 to Day 3)
STARTED
|
0
|
0
|
15
|
3
|
|
Part 2, Period 1 (Day 1 to Day 3)
COMPLETED
|
0
|
0
|
12
|
3
|
|
Part 2, Period 1 (Day 1 to Day 3)
NOT COMPLETED
|
0
|
0
|
3
|
0
|
|
Part 2, Period 2 (Day 1 to Day 3)
STARTED
|
0
|
0
|
12
|
3
|
|
Part 2, Period 2 (Day 1 to Day 3)
COMPLETED
|
0
|
0
|
12
|
3
|
|
Part 2, Period 2 (Day 1 to Day 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Gepotidacin (A/C/E)
Adult participants were randomized to receive a single dose of gepotidacin 1500 milligrams (mg) (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 12 hours (Treatment C) on Day 5 of Period 2, and two doses of gepotidacin 3000 mg separated by 6 hours (Treatment E) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
|
Placebo (B/D/F)
Adult participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 12 hours (Treatment D) on Day 5 of Period 2, and two doses of gepotidacin matching placebo separated by 6 hours (Treatment F) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
|
Gepotidacin (A/G)
Adolescent participants were randomized to receive a single dose of gepotidacin 1500 mg (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 6 hours (Treatment G) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
|
Placebo (B/H)
Adolescent participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 6 hours (Treatment H) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
|
|---|---|---|---|---|
|
Part 1, Period 1(Day 1 to Day 4)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Part 2, Period 1 (Day 1 to Day 3)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Part 2, Period 1 (Day 1 to Day 3)
Unable to swallow
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects
Baseline characteristics by cohort
| Measure |
Gepotidacin (A/C/E)
n=14 Participants
Adult participants were randomized to receive a single dose of gepotidacin 1500 milligrams (mg) (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 12 hours (Treatment C) on Day 5 of Period 2, and two doses of gepotidacin 3000 mg separated by 6 hours (Treatment E) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
|
Placebo (B/D/F)
n=2 Participants
Adult participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 12 hours (Treatment D) on Day 5 of Period 2, and two doses of gepotidacin matching placebo separated by 6 hours (Treatment F) on Day 9 of Period 3. All doses were administered orally with water after consumption of food.
|
Gepotidacin (A/G)
n=14 Participants
Adolescent participants were randomized to receive a single dose of gepotidacin 1500 mg (Treatment A) on Day 1 of Period 1 followed by two doses of gepotidacin 3000 mg separated by 6 hours (Treatment G) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
|
Placebo (B/H)
n=3 Participants
Adolescent participants were randomized to receive a single dose of gepotidacin matching placebo (Treatment B) on Day 1 of Period 1 followed by two doses of gepotidacin matching placebo separated by 6 hours (Treatment H) on Day 1 of Period 2. All doses were administered orally with water after consumption of food.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian- Central/South Asian Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter Population consisted of all participants in the PK Population (participants who received at least 1 dose of gepotidacin and had evaluable post-dose plasma concentration data for gepotidacin), for whom valid and evaluable PK parameters were derived.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of Gepotidacin 1500 mg
|
19.69 Hours*micrograms per milliliter
Geometric Coefficient of Variation 17.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) After Single Dose Administration of Gepotidacin 1500 mg
|
20.15 Hours*micrograms per milliliter
Geometric Coefficient of Variation 16.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose (AUC[0-24]) After Single Dose Administration of Gepotidacin 1500 mg
|
18.66 Hours*micrograms per milliliter
Geometric Coefficient of Variation 19.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 48 Hours Post-dose (AUC[0-48]) After Single Dose Administration of Gepotidacin 1500 mg
|
19.72 Hours*micrograms per milliliter
Geometric Coefficient of Variation 17.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Maximum Observed Concentration (Cmax) After Single Dose Administration of Gepotidacin 1500 mg
|
3.574 Micrograms per milliliter
Geometric Coefficient of Variation 38.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
|
91.21 Hours*micrograms per milliliter
Geometric Coefficient of Variation 22.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
|
87.09 Hours*micrograms per milliliter
Geometric Coefficient of Variation 26.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Dose 1
|
38.15 Hours*micrograms per milliliter
Geometric Coefficient of Variation 24.3
|
—
|
—
|
—
|
|
Part 1- Period 2: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Time Tau (Tau=12) (AUC[0-tau]) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Dose 2
|
44.41 Hours*micrograms per milliliter
Geometric Coefficient of Variation 22.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Dose 1
|
24.09 Hours*micrograms per milliliter
Geometric Coefficient of Variation 33.6
|
—
|
—
|
—
|
|
Part 1- Period 3: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Dose 2
|
40.13 Hours*micrograms per milliliter
Geometric Coefficient of Variation 29.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 and 24 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
|
83.45 Hours*micrograms per milliliter
Geometric Coefficient of Variation 22.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
|
82.43 Hours*micrograms per milliliter
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
|
90.53 Hours*micrograms per milliliter
Geometric Coefficient of Variation 22.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
|
86.49 Hours*micrograms per milliliter
Geometric Coefficient of Variation 26.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Accumulation Ratio for Cmax (RoCmax) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
|
1.109 Ratio
Geometric Coefficient of Variation 30.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Accumulation Ratio for AUC (RoAUC) Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
|
1.164 Ratio
Geometric Coefficient of Variation 12.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: RoCmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
|
1.544 Ratio
Geometric Coefficient of Variation 25.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: RoAUC Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
|
1.666 Ratio
Geometric Coefficient of Variation 25.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Dose 1
|
9.937 Micrograms per milliliter
Geometric Coefficient of Variation 24.2
|
—
|
—
|
—
|
|
Part 1- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 12 Hour Dosing Interval
Dose 2
|
11.02 Micrograms per milliliter
Geometric Coefficient of Variation 28.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Dose 1
|
8.423 Micrograms per milliliter
Geometric Coefficient of Variation 41.8
|
—
|
—
|
—
|
|
Part 1- Period 3: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Dosing Interval
Dose 2
|
13.01 Micrograms per milliliter
Geometric Coefficient of Variation 28.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: AUC(0-t) After Single Dose Administration of Gepotidacin 1500 mg
|
23.27 Hours*micrograms per milliliter
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: AUC(0-infinity) After Single Dose Administration of Gepotidacin 1500 mg
|
23.79 Hours*micrograms per milliliter
Geometric Coefficient of Variation 20.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg
|
22.06 Hours*micrograms per milliliter
Geometric Coefficient of Variation 22.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg
|
23.27 Hours*micrograms per milliliter
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: Cmax After Single Dose Administration of Gepotidacin 1500 mg
|
4.523 Micrograms per milliliter
Geometric Coefficient of Variation 29.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: AUC(0-t) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
|
115.6 Hours*micrograms per milliliter
Geometric Coefficient of Variation 23.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4 and 6 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Dose 1
|
32.37 Hours*micrograms per milliliter
Geometric Coefficient of Variation 22.0
|
—
|
—
|
—
|
|
Part 2- Period 2: AUC(0-tau) (Tau=6) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Dose 2
|
53.85 Hours*micrograms per milliliter
Geometric Coefficient of Variation 26.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 and 24 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: AUC(0-24) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
|
111.4 Hours*micrograms per milliliter
Geometric Coefficient of Variation 23.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: AUC(0-48) Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
|
115.6 Hours*micrograms per milliliter
Geometric Coefficient of Variation 23.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Dose 1
|
10.86 Micrograms per milliliter
Geometric Coefficient of Variation 26.8
|
—
|
—
|
—
|
|
Part 2- Period 2: Cmax Following Two Doses of Gepotidacin 3000 mg Administered at 6 Hour Interval
Dose 2
|
14.29 Micrograms per milliliter
Geometric Coefficient of Variation 29.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 19Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs is presented.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Common non-serious AEs
|
0 Participants
|
1 Participants
|
10 Participants
|
9 Participants
|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs and SAEs are presented.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=12 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Non-serious AEs and SAEs
Common non-serious AEs
|
2 Participants
|
9 Participants
|
12 Participants
|
—
|
|
Part 2: Number of Participants With Non-serious AEs and SAEs
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 19Population: Safety Population
Blood samples were collected for the analysis of following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Hematology Toxicities of Grade 3 or Higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: Safety Population
Blood samples were collected for the analysis of following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. The hematology abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the hematology parameter is presented.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=12 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Hematology Toxicities of Grade 3 or Higher
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 19Population: Safety population
Blood samples were collected for the analysis of following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose (fasting), potassium, sodium, magnesium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: Safety population
Blood samples were collected for the analysis of following clinical chemistry parameters: BUN, creatinine, glucose (fasting), potassium, sodium, magnesium, AST, ALT, alkaline phosphatase, total and direct bilirubin, creatine phosphokinase, calcium, chloride, carbon dioxide, total protein and albumin. The clinical chemistry abnormalities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the clinical chemistry parameter is presented
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=12 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Clinical Chemistry Toxicities of Grade 3 or Higher
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 19Population: Safety population
Urine samples were collected for the analysis of urine parameters including specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: Safety population
Urine samples were collected for the analysis of urine parameters including specific gravity, pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase. Toxicities were graded using the Division of Microbiology and Infectious Diseases toxicity grading where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe and Grade 4=Life-threatening. Number of participants with a grade 3 or higher toxicity for any of the urine parameter is presented
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=12 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Urinalysis Toxicities of Grade 3 or Higher
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 19Population: Safety population
SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 millimeters of mercury \[mmHg\]) and DBP (lower: \<45 and upper: \>100 mmHg).
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: Safety population
SBP and DBP were measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for vital signs were: SBP (lower: \<85 and upper: \>160 mmHg) and DBP (lower: \<45 and upper: \>100 mmHg).
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=12 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Number of Participants With SBP and DBP of Potential Clinical Importance
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 19Population: Safety population
Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
n=13 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: Safety population
Heart rate was measured in a semi-supine position after 5 minutes of rest. The potential clinically important range for heart rate was (lower:\<40 and upper: \>110 beats per minute).
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=12 Participants
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Heart Rate of Potential Clinical Importance
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3.Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 8 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 3- 48 hours, n= 2, 13
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 3- 48 hours, n= 2, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- predose, n= 2, 14
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- predose, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- predose 2, n= 2, 14
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1-predose 2, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- predose 3, n= 2, 14
|
1 Participants
|
12 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- predose 3, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 0.5 hours, n= 2, 14
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 0.5 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 1 hour, n= 2, 14
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 1 hour, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 1.5 hours, n= 2, 14
|
0 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 1.5 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 2 hours, n= 2, 14
|
0 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 2 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 2.5 hours, n= 2, 14
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 2.5 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 3 hours, n= 2, 14
|
0 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 3 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 4 hours, n= 2, 14
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 4 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 6 hours, n= 2, 14
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 6 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 8 hours, n= 2, 14
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 1- 12 hours, n= 2, 14
|
0 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 1- 12 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 2- 24 hours, n= 2, 14
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 2- 24 hours, n= 2, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, NCS, Day 2- 36 hours, n= 2, 13
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Period 1: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Abnormal, CS, Day 2- 36 hours, n= 2, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3Population: Safety population
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 15 hours
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 15 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 16 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 16 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 18 hours
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose
|
2 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 2
|
2 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1-predose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 3
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 0.5 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 0.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1 hour
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1.5 hours
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2.5 hours
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 3 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 3 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 4 hours
|
2 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 4 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 6 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 6 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 8 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 8 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 12 hours
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 12 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 12.5 hours
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 12.5 hours
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 13 hours
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 13 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 13.5 hours
|
2 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 13.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 14 hours
|
2 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 14 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 14.5 hours
|
2 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 14.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 18 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 20 hours
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 20 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 2- 24 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 2- 24 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 2- 36 hours
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 2- 36 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 3- 48 hours
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 3- 48 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 3- 60 hours
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 1: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 3- 60 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2, 48 and 60 hours on Day 3Population: Safety population
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS ECG findings are presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=2 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 2
|
0 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1-predose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 3
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 0.5 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 0.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1 hour
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1.5 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2.5 hours
|
0 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 3 hours
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 3 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 4 hours
|
2 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 4 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 6 hours
|
2 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 6 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 6.5 hours
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 6.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 7 hours
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 7 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 7.5 hours
|
0 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 7.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 8 hours
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 8 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 8.5 hours
|
2 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 8.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 9 hours
|
1 Participants
|
11 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 9 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 10 hours
|
2 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 10 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 12 hours
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 12 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 14 hours
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 14 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 18 hours
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 18 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 2- 24 hours
|
1 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 2- 24 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 2- 36 hours
|
0 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 2- 36 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 3- 48 hours
|
1 Participants
|
10 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 3- 48 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 3- 60 hours
|
0 Participants
|
8 Participants
|
—
|
—
|
|
Part 1: Period 3: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 3- 60 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3Population: Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose, n= 3, 14
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose, n= 3, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 2, n= 3, 14
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1-predose 2, n= 3, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 3, n= 3, 14
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose 3, n= 3, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 0.5 hours, n= 3, 14
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 0.5 hours, n= 3, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1 hour, n= 3, 13
|
0 Participants
|
7 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1 hour, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1.5 hours, n= 3, 13
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1.5 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2 hours, n= 3, 13
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2.5 hours, n= 3, 13
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2.5 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 3 hours, n= 3, 13
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 3 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 4 hours, n= 3, 14
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 4 hours, n= 3, 14
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 6 hours, n= 3, 13
|
0 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 6 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 8 hours, n= 3, 13
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 8 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 12 hours, n= 3, 13
|
0 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 12 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 24 hours, n= 3, 13
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 24 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 36 hours, n= 3, 13
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 36 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 48 hours, n= 3, 13
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 1: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 48 hours, n= 3, 13
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, predose 2, predose 3, 0.5. 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18 hours on Day 1, 24, 36 hours on Day 2 and 48 hours on Day 3Population: Safety population
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and QTc intervals and calculated heart rate. Data for abnormal NCS and CS were presented CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=3 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 2
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1-predose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- predose 3
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- predose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 0.5 hours
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 0.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1 hour
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 1.5 hours
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 1.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2 hours
|
0 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 2.5 hours
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 2.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 3 hours
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 3 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 4 hours
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 4 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 6 hours
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 6 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 6.5 hours
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 6.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 7 hours
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 7 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 7.5 hours
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 7.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 8 hours
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 8 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 8.5 hours
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 8.5 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 9 hours
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 9 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 10 hours
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 10 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 12 hours
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 12 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 14 hours
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 14 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 18 hours
|
1 Participants
|
7 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 18 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 24 hours
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 24 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 36 hours
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 36 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, NCS, Day 1- 48 hours
|
2 Participants
|
7 Participants
|
—
|
—
|
|
Part 2: Period 2: Number of Participants With Abnormal 12-lead ECG Findings
Abnormal, CS, Day 1- 48 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Total Unchanged Drug (Ae Total) After Single Dose Administration of Gepotidacin 1500 mg
|
328.1 Milligrams
Standard Deviation 68.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Urine samples were collected at the specified intervals for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (0-2), n=14
|
50.87 Milligrams
Standard Deviation 61.194
|
—
|
—
|
—
|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (2-4), n=13
|
92.98 Milligrams
Standard Deviation 51.315
|
—
|
—
|
—
|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (4-6), n=13
|
68.14 Milligrams
Standard Deviation 39.927
|
—
|
—
|
—
|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (6-8), n=14
|
47.68 Milligrams
Standard Deviation 25.551
|
—
|
—
|
—
|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (8-12), n=14
|
35.71 Milligrams
Standard Deviation 11.458
|
—
|
—
|
—
|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (12-24), n=14
|
29.10 Milligrams
Standard Deviation 7.8849
|
—
|
—
|
—
|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (24-36), n=13
|
10.72 Milligrams
Standard Deviation 4.2330
|
—
|
—
|
—
|
|
Part 1- Period 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) After Single Dose Administration of Gepotidacin 1500 mg
Ae (36-48), n=13
|
5.601 Milligrams
Standard Deviation 2.0351
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.Population: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
|
3340.0 Hours*micrograms per milliliter
Standard Deviation 2340.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were be collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
|
3567.9 Hours*micrograms per milliliter
Standard Deviation 2377.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100 percent (%).
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) After Single Dose Administration of Gepotidacin 1500 mg
|
21.874 Percent dose excreted
Standard Deviation 4.5393
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Renal Clearance of Drug (CLr) After Single Dose Administration of Gepotidacin 1500 mg
|
16.66 Liters per hour
Standard Deviation 3.4123
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
|
1452.7 Milligrams
Standard Deviation 223.10
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points. Ae total were calculated by adding all the fractions of drug collected over all the allotted time intervals
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
|
1293.9 Milligrams
Standard Deviation 367.48
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (0-2), n=13
|
158.5 Milligrams
Standard Deviation 81.599
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (2-4), n=12
|
186.1 Milligrams
Standard Deviation 73.777
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (4-6), n=13
|
143.6 Milligrams
Standard Deviation 73.790
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (6-8), n=12
|
66.80 Milligrams
Standard Deviation 22.886
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (8-12), n=13
|
64.98 Milligrams
Standard Deviation 23.987
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (12-14), n=12
|
204.1 Milligrams
Standard Deviation 113.98
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (14-16), n=13
|
254.3 Milligrams
Standard Deviation 83.985
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (16-18), n=12
|
156.7 Milligrams
Standard Deviation 85.023
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (18-20), n=13
|
80.29 Milligrams
Standard Deviation 43.563
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (20-24), n=13
|
79.23 Milligrams
Standard Deviation 25.216
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (24-36), n=13
|
74.53 Milligrams
Standard Deviation 21.862
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (36-48), n=13
|
20.35 Milligrams
Standard Deviation 5.7977
|
—
|
—
|
—
|
|
Part 1- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Ae (48-60), n=13
|
10.51 Milligrams
Standard Deviation 5.0038
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18 -24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (0-2), n=12
|
97.51 Milligrams
Standard Deviation 70.551
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (2-4), n=10
|
216.8 Milligrams
Standard Deviation 97.543
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (4-6), n=13
|
172.2 Milligrams
Standard Deviation 98.842
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (6-8), n=12
|
242.3 Milligrams
Standard Deviation 138.61
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (8-10), n=11
|
251.0 Milligrams
Standard Deviation 115.23
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (10-12), n=12
|
151.6 Milligrams
Standard Deviation 91.694
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (12-14), n=12
|
107.3 Milligrams
Standard Deviation 77.898
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (14-18), n=12
|
72.83 Milligrams
Standard Deviation 27.363
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (18-24), n=12
|
63.91 Milligrams
Standard Deviation 48.404
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (24-36), n=13
|
39.13 Milligrams
Standard Deviation 12.057
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (36-48), n=13
|
15.64 Milligrams
Standard Deviation 5.9580
|
—
|
—
|
—
|
|
Part 1- Period 3: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Ae (48-60), n=13
|
8.889 Milligrams
Standard Deviation 4.1747
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8 and 8-12 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: AUC(0-tau) (Tau=12 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
|
7287.4 Hours*micrograms per milliliter
Standard Deviation 4050.81
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4 and 4-6 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: AUC(0-tau) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
|
3943.5 Hours*micrograms per milliliter
Standard Deviation 3015.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20 and 20-24 hours post dosePopulation: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
|
17431.6 Hours*micrograms per milliliter
Standard Deviation 10132.84
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
|
13174.1 Hours*micrograms per milliliter
Standard Deviation 8648.92
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval (Urine)
|
19128.3 Hours*micrograms per milliliter
Standard Deviation 10934.06
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval (Urine)
|
14277.1 Hours*micrograms per milliliter
Standard Deviation 9045.37
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
|
24.212 Percent dose excreted
Standard Deviation 3.7184
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
|
21.565 Percent dose excreted
Standard Deviation 6.1246
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-14, 14-16, 16-18, 18-20, 20-24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
|
15.88 Liters per hour
Standard Deviation 2.0305
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36, 36-48 and 48-60 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
|
14.81 Liters per hour
Standard Deviation 3.4456
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed
Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: Ae Total After Single Dose Administration of Gepotidacin 1500 mg
|
361.5 Milligrams
Standard Deviation 83.95
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-2, 2-4, 4-6, 6-8, 8-12, 12-24,24-36 and 36-48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (0-2), n=13
|
16.00 Milligrams
Standard Deviation 28.532
|
—
|
—
|
—
|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (2-4), n=12
|
130.5 Milligrams
Standard Deviation 49.526
|
—
|
—
|
—
|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (4-6), n=12
|
85.47 Milligrams
Standard Deviation 37.814
|
—
|
—
|
—
|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (6-8), n=13
|
58.74 Milligrams
Standard Deviation 32.586
|
—
|
—
|
—
|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (8-12), n=13
|
40.15 Milligrams
Standard Deviation 14.232
|
—
|
—
|
—
|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (12-24), n=13
|
30.87 Milligrams
Standard Deviation 11.638
|
—
|
—
|
—
|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (24-36), n=13
|
10.11 Milligrams
Standard Deviation 4.6348
|
—
|
—
|
—
|
|
Part 2- Period 1: Ae(t1-t2) After Single Dose Administration of Gepotidacin 1500 mg
Ae (36-48), n=13
|
6.312 Milligrams
Standard Deviation 2.5619
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12 and 12-24 hours post-dose.Population: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: AUC(0-24) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
|
4513.7 Hours*micrograms per milliliter
Standard Deviation 2623.81
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: AUC(0-48) After Single Dose Administration of Gepotidacin 1500 mg (Urine)
|
4948.4 Hours*micrograms per milliliter
Standard Deviation 2721.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: fe% After Single Dose Administration of Gepotidacin 1500 mg
|
24.100 Percent dose excreted
Standard Deviation 5.5968
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-12, 12-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: CLr After Single Dose Administration of Gepotidacin 1500 mg
|
15.56 Liters per hour
Standard Deviation 3.7934
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: Ae Total After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
|
1719.4 Milligrams
Standard Deviation 402.71
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (0-2), n=11
|
105.3 Milligrams
Standard Deviation 121.67
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (2-4), n=10
|
202.0 Milligrams
Standard Deviation 70.108
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (4-6), n=10
|
229.7 Milligrams
Standard Deviation 113.95
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (6-8), n=11
|
244.9 Milligrams
Standard Deviation 149.66
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (8-10), n=12
|
446.6 Milligrams
Standard Deviation 138.33
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (10-12), n=10
|
228.3 Milligrams
Standard Deviation 79.619
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (12-14), n=11
|
172.5 Milligrams
Standard Deviation 63.150
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (14-18), n=10
|
132.6 Milligrams
Standard Deviation 51.586
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (18-24), n=10
|
67.56 Milligrams
Standard Deviation 40.521
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (24-36), n=12
|
61.99 Milligrams
Standard Deviation 51.367
|
—
|
—
|
—
|
|
Part 2- Period 2: Ae(t1-t2) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Ae (36-48), n=12
|
14.86 Milligrams
Standard Deviation 8.3210
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6 hours post-dosePopulation: PK parameter population
Urine samples will be collected at indicated time points for pharmacokinetic analysis of gepotidacin
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: AUC(0-tau) (Tau=6 Hours Post-dose) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
|
5364.4 Hours*micrograms per milliliter
Standard Deviation 2877.94
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18 and 18-24 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: AUC(0-24) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
|
22052.8 Hours*micrograms per milliliter
Standard Deviation 11410.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dose.Population: PK parameter population
Urine samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: AUC(0-48) After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval (Urine)
|
24500.7 Hours*micrograms per milliliter
Standard Deviation 12281.23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. fe% was calculated as: (Ae total/Dose) x 100%.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: fe% After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
|
28.657 Percent dose excreted
Standard Deviation 6.7119
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-14, 14-18, 18-24, 24-36 and 36-48 hours post-dosePopulation: PK parameter population
Urine samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: CLr After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
|
14.93 Liters per hour
Standard Deviation 3.9558
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) After Single Dose Administration of Gepotidacin 1500 mg
|
3.000 Hours
Interval 0.5 to 6.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) After Single Dose Administration of Gepotidacin 1500 mg
|
0.000 Hours
Interval 0.0 to 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=14 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of Gepotidacin 1500 mg
|
11.533 Hours
Geometric Coefficient of Variation 36.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Dose 1
|
2.000 Hours
Interval 1.0 to 4.0
|
—
|
—
|
—
|
|
Part 1- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
Dose 2
|
1.567 Hours
Interval 1.0 to 4.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Dose 1
|
2.633 Hours
Interval 0.5 to 5.42
|
—
|
—
|
—
|
|
Part 1- Period 3: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
Dose 2
|
1.500 Hours
Interval 1.0 to 3.28
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
|
0.000 Hours
Interval 0.0 to 0.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
|
0.000 Hours
Interval 0.0 to 0.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 12 Hour Dosing Interval
|
10.976 Hours
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36, 48 and 60 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 1- Period 3: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Dosing Interval
|
12.020 Hours
Geometric Coefficient of Variation 14.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: Tmax After Single Dose Administration of Gepotidacin 1500 mg
|
3.000 Hours
Interval 1.5 to 6.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: Tlag After Single Dose Administration of Gepotidacin 1500 mg
|
0.500 Hours
Interval 0.0 to 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dosePopulation: PK parameter population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=13 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 1: t1/2 After Single Dose Administration of Gepotidacin 1500 mg
|
12.984 Hours
Geometric Coefficient of Variation 16.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Dose 1
|
2.750 Hours
Interval 1.0 to 4.0
|
—
|
—
|
—
|
|
Part 2- Period 2: Tmax After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
Dose 2
|
1.500 Hours
Interval 1.0 to 3.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: Tlag After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
|
0.000 Hours
Interval 0.0 to 0.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 18, 24, 36 and 48 hours post-dosePopulation: PK parameter population
Blood samples were collected at indicated time points for pharmacokinetic analysis of gepotidacin. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Gepotidacin 1500 mg
n=12 Participants
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 1500 mg
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|
|
Part 2- Period 2: t1/2 After Two Doses Administration of Gepotidacin 3000 mg at 6 Hour Interval
|
6.982 Hours
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
Adverse Events
Part 1 : Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part1: Gepotidacin 1500 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Gepotidacin 3000 mg 12 Hour Interval
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 1: Gepotidacin 3000 mg 6 Hour Interval
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2 : Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Gepotidacin 1500 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2: Gepotidacin 3000 mg 6 Hour Interval
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 : Placebo
n=2 participants at risk
Adult participants received a single oral dose of gepotidacin matching placebo on Day 1 of Period 1
|
Part1: Gepotidacin 1500 mg
n=14 participants at risk
Adult participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 1: Gepotidacin 3000 mg 12 Hour Interval
n=13 participants at risk
Adult participants were administered two doses of gepotidacin 3000 mg separated by 12 hours (Dose 1 at Hour 0 and dose 2 at Hour 12)
|
Part 1: Gepotidacin 3000 mg 6 Hour Interval
n=13 participants at risk
Adult participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
Part 2 : Placebo
n=3 participants at risk
Adolescent participants received a single oral dose of gepotidacin matching placebo on Day 1 of Period 1
|
Part 2: Gepotidacin 1500 mg
n=14 participants at risk
Adolescent participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1
|
Part 2: Gepotidacin 3000 mg 6 Hour Interval
n=12 participants at risk
Adolescent participants were administered two doses of gepotidacin 3000 mg separated by 6 hours (Dose 1 at Hour 0 and dose 2 at Hour 6)
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
61.5%
8/13 • Number of events 8 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
61.5%
8/13 • Number of events 8 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
21.4%
3/14 • Number of events 3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
41.7%
5/12 • Number of events 5 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
30.8%
4/13 • Number of events 4 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
30.8%
4/13 • Number of events 4 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
14.3%
2/14 • Number of events 2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
25.0%
3/12 • Number of events 3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Number of events 3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
23.1%
3/13 • Number of events 3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
75.0%
9/12 • Number of events 9 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
15.4%
2/13 • Number of events 2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
41.7%
5/12 • Number of events 5 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
14.3%
2/14 • Number of events 2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
16.7%
2/12 • Number of events 2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
8.3%
1/12 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.7%
1/13 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
7.1%
1/14 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
33.3%
4/12 • Number of events 4 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
14.3%
2/14 • Number of events 2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
8.3%
1/12 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/12 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
|
General disorders
Chest discomfort
|
0.00%
0/2 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/13 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
0.00%
0/14 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
8.3%
1/12 • Number of events 1 • Non-SAEs and SAEs were collected from start of study intervention (Day 1) up to Day 19 for Part 1 and up to Day 21 for Part 2.
Safety Population consisted of all participants who received at least 1 dose of study intervention.
|
Additional Information
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