Trial Outcomes & Findings for Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis) (NCT NCT03568942)
NCT ID: NCT03568942
Last Updated: 2020-06-29
Results Overview
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population consisted of all participants who received gepotidacin 1500 mg BID through the completion of all PK collections for whom valid and evaluable plasma PK parameters were derived for gepotidacin.
COMPLETED
PHASE2
22 participants
Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose
2020-06-29
Participant Flow
This was an open-label study to evaluate the pharmacokinetic (PK) of repeat oral doses of gepotidacin in adult female participants with clinical signs and symptoms of acute cystitis.
A total of 22 participants were enrolled in this study. This study was conducted at a single center in the United States.
Participant milestones
| Measure |
Gepotidacin 1500 mg
All participants received gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Gepotidacin 1500 mg
All participants received gepotidacin 1500 milligram (mg) (2\*750 mg, tablets), twice daily (BID), orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Overall Study
Family emergency
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1
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Baseline characteristics by cohort
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Age, Continuous
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37.1 Years
STANDARD_DEVIATION 12.26 • n=5 Participants
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Sex: Female, Male
Female
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22 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African American
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4 Participants
n=5 Participants
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Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
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18 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population consisted of all participants who received gepotidacin 1500 mg BID through the completion of all PK collections for whom valid and evaluable plasma PK parameters were derived for gepotidacin.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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|---|---|
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Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin
Day 4, n=21
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29313.8 Hours* nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.8
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Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin
Day 1, n=20
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20236.2 Hours* nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 28.6
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PRIMARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Maximum Plasma Concentration (Cmax) of Gepotidacin
Day 1, n=20
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5891 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47.3
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Maximum Plasma Concentration (Cmax) of Gepotidacin
Day 4, n=21
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8437 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.0
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PRIMARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Time of Occurrence of Cmax (Tmax) of Gepotidacin
Day 1, n=20
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1.500 Hours
Interval 0.47 to 3.07
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Time of Occurrence of Cmax (Tmax) of Gepotidacin
Day 4, n=21
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1.917 Hours
Interval 0.45 to 4.12
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PRIMARY outcome
Timeframe: Day 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. CLss/F was calculated as Dose divided by AUC(0-tau).
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=21 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Apparent Steady State Clearance (CLss/F) of Gepotidacin
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51.17 Liters per hour
Geometric Coefficient of Variation 31.8
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PRIMARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Accumulation ratio (Ro) was calculated as ratio of AUC(0-tau) at Day 4 to AUC(0-tau) at Day 1.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=19 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Accumulation Ratio (Ro) of Gepotidacin
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1.402 Ratio
Geometric Coefficient of Variation 20.4
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PRIMARY outcome
Timeframe: Days 1 to 5: Pre-dosePopulation: PK Parameter Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Plasma Pre-dose Concentration (Ctau) of Gepotidacin
Day 1, Pre-dose, n=22
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NA ng/mL
Geometric Coefficient of Variation NA
Data was not available as all concentration values were below the lower limit of quantification.
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Plasma Pre-dose Concentration (Ctau) of Gepotidacin
Day 2, Pre-dose, n=21
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620.5 ng/mL
Geometric Coefficient of Variation 62.3
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Plasma Pre-dose Concentration (Ctau) of Gepotidacin
Day 3, Pre-dose, n=21
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789.3 ng/mL
Geometric Coefficient of Variation 37.4
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Plasma Pre-dose Concentration (Ctau) of Gepotidacin
Day 4, Pre-dose, n=21
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851.4 ng/mL
Geometric Coefficient of Variation 41.4
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Plasma Pre-dose Concentration (Ctau) of Gepotidacin
Day 5, Pre-dose, n=21
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818.9 ng/mL
Geometric Coefficient of Variation 46.4
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SECONDARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Ae12hours was calculated by adding all the fractions of drug collected over all the allotted time intervals.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin
Day 1, n=20
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298.7 mg
Geometric Coefficient of Variation 107.6
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Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin
Day 4, n=21
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460.0 mg
Geometric Coefficient of Variation 55.8
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SECONDARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Ae(t1-t2) measure the amount of drug excreted in urine in a time intervals 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose on Days 1 and 4. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 1, Ae (0-2),n=17
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NA mg
Geometric Coefficient of Variation NA
Data was not available as all concentration values were below the lower limit of quantification.
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 4, Ae (0-2),n=18
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63.05 mg
Geometric Coefficient of Variation 151.7
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 1, Ae (2-4),n=17
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131.9 mg
Geometric Coefficient of Variation 59.5
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 4, Ae (2-4),n=12
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168.1 mg
Geometric Coefficient of Variation 96.5
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 1, Ae (4-6) ,n=14
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87.01 mg
Geometric Coefficient of Variation 90.0
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 4, Ae (4-6),n=18
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128.6 mg
Geometric Coefficient of Variation 96.8
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 1, Ae (6-8),n=16
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54.60 mg
Geometric Coefficient of Variation 72.1
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 4, Ae (6-8),n=17
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84.08 mg
Geometric Coefficient of Variation 92.0
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 1, Ae (8-10),n=9
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18.51 mg
Geometric Coefficient of Variation 49.9
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 4, Ae (8-10),n=10
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34.68 mg
Geometric Coefficient of Variation 69.2
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 1, Ae (10-12),n=14
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18.03 mg
Geometric Coefficient of Variation 151.2
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Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin
Day 4, Ae (10-12),n=15
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32.77 mg
Geometric Coefficient of Variation 83.5
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SECONDARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. fe% was calculated as fe% = (Ae 12 hours/Dose) multiply by 100. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin
Day 1, n=20
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19.91 Percentage of dose
Geometric Coefficient of Variation 107.6
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Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin
Day 4, n=21
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30.67 Percentage of dose
Geometric Coefficient of Variation 55.8
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SECONDARY outcome
Timeframe: Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. CLr was calculated as CLr = Ae 12 hours/AUC(0-tau). The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Renal Clearance (CLr) of Gepotidacin
Day 1, n=20
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14.76 Liters per hour
Geometric Coefficient of Variation 118.2
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Renal Clearance (CLr) of Gepotidacin
Day 4, n=21
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15.69 Liters per hour
Geometric Coefficient of Variation 45.2
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SECONDARY outcome
Timeframe: Days 1 to 5: Pre-dosePopulation: PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Urine Pre-dose Concentration (Ctau) of Gepotidacin
Day 1, Pre-dose, n=21
|
NA Micrograms per milliliter
Geometric Coefficient of Variation NA
Data was not available as all concentration values were below the lower limit of quantification.
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Urine Pre-dose Concentration (Ctau) of Gepotidacin
Day 2, Pre-dose, n=20
|
279.1 Micrograms per milliliter
Geometric Coefficient of Variation 154.7
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Urine Pre-dose Concentration (Ctau) of Gepotidacin
Day 3, Pre-dose, n=21
|
322.2 Micrograms per milliliter
Geometric Coefficient of Variation 138.8
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Urine Pre-dose Concentration (Ctau) of Gepotidacin
Day 4, Pre-dose, n=21
|
326.7 Micrograms per milliliter
Geometric Coefficient of Variation 248.7
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Urine Pre-dose Concentration (Ctau) of Gepotidacin
Day 5, Pre-dose, n=21
|
351.7 Micrograms per milliliter
Geometric Coefficient of Variation 146.5
|
SECONDARY outcome
Timeframe: Up to Day 31Population: Safety Population
An AEs is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs)
Non-SAEs
|
21 Participants
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Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs)
SAEs
|
1 Participants
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SECONDARY outcome
Timeframe: Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Vital signs including SBP and DBP were measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 2,n=22
|
-3.1 Millimeters of mercury
Standard Deviation 16.13
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 3,n=22
|
-0.3 Millimeters of mercury
Standard Deviation 15.74
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 4,n=21
|
-1.5 Millimeters of mercury
Standard Deviation 13.10
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 5,n=21
|
0.9 Millimeters of mercury
Standard Deviation 15.46
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Days 10 to 13,n=20
|
1.5 Millimeters of mercury
Standard Deviation 14.21
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 2,n=22
|
-2.3 Millimeters of mercury
Standard Deviation 9.32
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 3,n=22
|
-1.1 Millimeters of mercury
Standard Deviation 11.64
|
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 4,n=21
|
0.5 Millimeters of mercury
Standard Deviation 9.65
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 5,n=21
|
4.7 Millimeters of mercury
Standard Deviation 7.23
|
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Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Days 10 to 13,n=20
|
2.7 Millimeters of mercury
Standard Deviation 8.77
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SECONDARY outcome
Timeframe: Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Vital sign including pulse rate was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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|---|---|
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Change From Baseline in Pulse Rate
Day 2,n=22
|
2.2 Beats per minute
Standard Deviation 9.07
|
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Change From Baseline in Pulse Rate
Day 3,n=22
|
2.4 Beats per minute
Standard Deviation 10.24
|
|
Change From Baseline in Pulse Rate
Day 4,n=21
|
2.9 Beats per minute
Standard Deviation 12.60
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Change From Baseline in Pulse Rate
Day 5,n=21
|
7.2 Beats per minute
Standard Deviation 9.50
|
|
Change From Baseline in Pulse Rate
Days 10 to 13,n=20
|
0.8 Beats per minute
Standard Deviation 12.38
|
SECONDARY outcome
Timeframe: Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Vital sign including body temperature was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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|---|---|
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Change From Baseline in Body Temperature
Day 2,n=22
|
-0.05 Degree Celsius
Standard Deviation 0.246
|
|
Change From Baseline in Body Temperature
Day 3,n=22
|
-0.06 Degree Celsius
Standard Deviation 0.292
|
|
Change From Baseline in Body Temperature
Day 4,n=21
|
0.02 Degree Celsius
Standard Deviation 0.405
|
|
Change From Baseline in Body Temperature
Day 5,n=21
|
-0.05 Degree Celsius
Standard Deviation 0.287
|
|
Change From Baseline in Body Temperature
Days 10 to 13,n=20
|
-0.10 Degree Celsius
Standard Deviation 0.270
|
SECONDARY outcome
Timeframe: Baseline; Day 1: 2 hours; Day 4: pre-dose and 2 hoursPopulation: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
A 12-lead ECG was measured in semi-supine position using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
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|---|---|
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Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
PR interval, Day 1: 2 hours, n=22
|
-1.9 Millisecond
Standard Deviation 11.34
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
PR interval, Day 4: pre-dose,n=21
|
0.1 Millisecond
Standard Deviation 14.56
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
PR interval, Day 4: 2 hours,n=21
|
-3.5 Millisecond
Standard Deviation 10.17
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QRS duration, Day 1: 2 hours, n=22
|
-0.7 Millisecond
Standard Deviation 8.32
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QRS duration, Day 4: pre-dose,n=21
|
-0.9 Millisecond
Standard Deviation 4.10
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QRS duration, Day 4: 2 hours,n=21
|
2.1 Millisecond
Standard Deviation 4.29
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QT interval, Day 1: 2 hours, n=22
|
15.0 Millisecond
Standard Deviation 21.56
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QT interval, Day 4: pre-dose,n=21
|
-5.4 Millisecond
Standard Deviation 26.86
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QT interval, Day 4: 2 hours,n=21
|
8.7 Millisecond
Standard Deviation 27.46
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QTcB interval, Day 1: 2 hours, n=22
|
4.5 Millisecond
Standard Deviation 14.37
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QTcB interval, Day 4: pre-dose,n=21
|
-6.2 Millisecond
Standard Deviation 17.25
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QTcB interval, Day 4: 2 hours,n=21
|
0.4 Millisecond
Standard Deviation 27.33
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QTcF interval, Day 1: 2 hours, n=22
|
8.2 Millisecond
Standard Deviation 14.45
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QTcF interval, Day 4: pre-dose,n=21
|
-5.8 Millisecond
Standard Deviation 17.57
|
|
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)
QTcF interval, Day 4: 2 hours,n=21
|
3.4 Millisecond
Standard Deviation 24.84
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet counts. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 3, Basophils, n=16
|
0.013 10^9 cells per liter
Standard Deviation 0.0652
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 5, Basophils, n=14
|
-0.003 10^9 cells per liter
Standard Deviation 0.0164
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Days 10 to 13, Basophils, n=15
|
0.000 10^9 cells per liter
Standard Deviation 0.0146
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 3, Eosinophils, n=18
|
0.013 10^9 cells per liter
Standard Deviation 0.0550
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 5, Eosinophils, n=17
|
-0.003 10^9 cells per liter
Standard Deviation 0.0969
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Days 10 to 13, Eosinophils, n=16
|
0.051 10^9 cells per liter
Standard Deviation 0.0492
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 3, Lymphocytes, n=19
|
0.039 10^9 cells per liter
Standard Deviation 0.5201
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 5, Lymphocytes, n=18
|
0.041 10^9 cells per liter
Standard Deviation 0.4856
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Days 10 to 13, Lymphocytes, n=17
|
0.232 10^9 cells per liter
Standard Deviation 0.4001
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 3, Monocytes, n=19
|
-0.053 10^9 cells per liter
Standard Deviation 0.1080
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 5, Monocytes, n=18
|
-0.069 10^9 cells per liter
Standard Deviation 0.1468
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Days 10 to 13, Monocytes, n=17
|
-0.039 10^9 cells per liter
Standard Deviation 0.1415
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 3, Neutrophils, n=19
|
-0.673 10^9 cells per liter
Standard Deviation 1.9611
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 5, Neutrophils, n=18
|
-0.948 10^9 cells per liter
Standard Deviation 2.3174
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Days 10 to 13, Neutrophils, n=17
|
-0.841 10^9 cells per liter
Standard Deviation 1.4779
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 3, Platelet counts, n=19
|
-3.6 10^9 cells per liter
Standard Deviation 22.94
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Day 5, Platelet counts, n=18
|
7.8 10^9 cells per liter
Standard Deviation 32.33
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts
Days 10 to 13, Platelet counts, n=17
|
3.7 10^9 cells per liter
Standard Deviation 33.59
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Day 3, n=19
|
-3.4 Grams per liter
Standard Deviation 8.15
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Day 5, n=18
|
-0.6 Grams per liter
Standard Deviation 9.34
|
|
Change From Baseline in Hematology Parameter: Hemoglobin
Days 10 to 13, n=17
|
-8.2 Grams per liter
Standard Deviation 7.40
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Hematology Parameter: Hematocrit
Day 3, n=19
|
0.75 Percentage of red blood cells in blood
Standard Deviation 3.186
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Day 5, n=18
|
-0.54 Percentage of red blood cells in blood
Standard Deviation 3.643
|
|
Change From Baseline in Hematology Parameter: Hematocrit
Days 10 to 13, n=17
|
-2.30 Percentage of red blood cells in blood
Standard Deviation 2.956
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin
Day 3, n=19
|
0.13 Picogram
Standard Deviation 0.564
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin
Day 5, n=18
|
0.03 Picogram
Standard Deviation 0.465
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin
Days 10 to 13, n=17
|
0.16 Picogram
Standard Deviation 0.348
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Volume. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Day 3, n=19
|
4.53 Femtoliter
Standard Deviation 5.814
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Day 5, n=18
|
-0.72 Femtoliter
Standard Deviation 4.668
|
|
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume
Days 10 to 13, n=17
|
1.14 Femtoliter
Standard Deviation 6.252
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Red blood cell count. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Hematology Parameter: Red Blood Cell Count
Day 3, n=19
|
-0.135 10^12 cells per liter
Standard Deviation 0.2574
|
|
Change From Baseline in Hematology Parameter: Red Blood Cell Count
Day 5, n=18
|
-0.031 10^12 cells per liter
Standard Deviation 0.3060
|
|
Change From Baseline in Hematology Parameter: Red Blood Cell Count
Days 10 to 13, n=17
|
-0.298 10^12 cells per liter
Standard Deviation 0.2552
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin: Day 3, n=22
|
-2.0 Grams per liter
Standard Deviation 2.45
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin: Day 5, n=21
|
-1.4 Grams per liter
Standard Deviation 2.71
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin: Days 10 to 13, n=20
|
-1.3 Grams per liter
Standard Deviation 2.90
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein: Day 3, n=22
|
-3.0 Grams per liter
Standard Deviation 3.82
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein: Day 5, n=21
|
-2.6 Grams per liter
Standard Deviation 4.52
|
|
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein: Days 10 to 13, n=20
|
-2.4 Grams per liter
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin
Bilirubin: Day 3, n=14
|
-1.8932 Micromoles per liter
Standard Deviation 4.06405
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin
Creatinine: Day 3, n=22
|
2.411 Micromoles per liter
Standard Deviation 9.9048
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin
Creatinine: Day 5, n=21
|
1.684 Micromoles per liter
Standard Deviation 7.7162
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin
Creatinine: Days 10 to 13, n=20
|
0.442 Micromoles per liter
Standard Deviation 7.2981
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin
Bilirubin: Day 5, n=15
|
-1.6986 Micromoles per liter
Standard Deviation 3.41356
|
|
Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin
Bilirubin: Days 10 to 13, n=14
|
-1.6856 Micromoles per liter
Standard Deviation 3.42845
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: ALT, AST and ALP. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
ALT: Day 3, n=22
|
-1.5 International units per liter
Standard Deviation 4.99
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
ALT: Day 5, n=21
|
1.7 International units per liter
Standard Deviation 7.51
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
ALT: Days 10 to 13, n=20
|
1.7 International units per liter
Standard Deviation 7.44
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
AST: Day 3, n=22
|
-1.3 International units per liter
Standard Deviation 3.22
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
AST: Day 5, n=21
|
1.3 International units per liter
Standard Deviation 3.77
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
AST: Days 10 to 13, n=20
|
2.1 International units per liter
Standard Deviation 3.22
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
ALP: Day 3, n=22
|
-3.3 International units per liter
Standard Deviation 7.91
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
ALP: Day 5, n=21
|
-4.3 International units per liter
Standard Deviation 8.84
|
|
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)
ALP: Days 10 to 13, n=20
|
-4.5 International units per liter
Standard Deviation 7.76
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 3, Glucose, n=22
|
0.13121 Millimoles per liter
Standard Deviation 1.237031
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 5, Glucose, n=21
|
0.87495 Millimoles per liter
Standard Deviation 1.382514
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Days 10 to 13, Glucose, n=20
|
-0.05274 Millimoles per liter
Standard Deviation 0.498607
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 3, Calcium, n=22
|
-0.05330 Millimoles per liter
Standard Deviation 0.075175
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 5, Calcium, n=21
|
-0.05228 Millimoles per liter
Standard Deviation 0.093648
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Days 10 to 13, Calcium, n=20
|
-0.07110 Millimoles per liter
Standard Deviation 0.095536
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 3, Chloride, n=22
|
0.5 Millimoles per liter
Standard Deviation 2.42
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 5, Chloride, n=21
|
0.3 Millimoles per liter
Standard Deviation 2.90
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Days 10 to 13, Chloride, n=20
|
0.3 Millimoles per liter
Standard Deviation 2.15
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 3, Potassium, n=22
|
0.04 Millimoles per liter
Standard Deviation 0.359
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 5, Potassium, n=21
|
-0.05 Millimoles per liter
Standard Deviation 0.425
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Days 10 to 13, Potassium, n=20
|
0.01 Millimoles per liter
Standard Deviation 0.419
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 3, Sodium, n=22
|
-0.7 Millimoles per liter
Standard Deviation 2.29
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 5, Sodium, n=21
|
-1.6 Millimoles per liter
Standard Deviation 2.13
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Days 10 to 13, Sodium, n=20
|
-0.9 Millimoles per liter
Standard Deviation 1.65
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 3, Urea, n=22
|
0.1298 Millimoles per liter
Standard Deviation 1.15836
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Day 5, Urea, n=21
|
0.0680 Millimoles per liter
Standard Deviation 1.06275
|
|
Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea
Days 10 to 13, Urea, n=20
|
0.3927 Millimoles per liter
Standard Deviation 1.18063
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Urine samples were collected at indicated time points to analyze parameters including glucose and nitrites by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative and positive in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Baseline:Glucose,Negative,n=22
|
22 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Day 3:Glucose,Negative,n=22
|
22 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Day 5:Glucose,Negative,n=21
|
21 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Days 10 to 13:Glucose,Negative,n=20
|
20 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Baseline: Nitrites,Negative,n=22
|
13 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Baseline: Nitrites,Positive,n=22
|
9 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Day 3: Nitrites,Negative,n=22
|
22 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Day 5: Nitrites,Negative,n=21
|
21 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites
Days 10 to 13: Nitrites,Negative,n=20
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Urine samples were collected at indicated time points to analyze parameter including ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, 5 indicates 5 milligrams per deciliter (mg/dL) and 20 indicates 20 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Number of Participants With Urinalysis Dipstick Results: Ketones
Baseline:Ketones,Negative,n=22
|
21 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Ketones
Baseline:Ketones,20,n=22
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Ketones
Day 3:Ketones,Negative,n=22
|
22 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Ketones
Day 5:Ketones,Negative,n=21
|
21 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Ketones
Days 10 to 13:Ketones,Negative,n=20
|
18 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Ketones
Days 10 to 13:Ketones,5,n=20
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Urine samples were collected at indicated time points to analyze parameter including leukocyte esterase by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace indicates 15 Leukocytes per microliter (Leuko/mcL), Small indicates 70 Leuko/mcL, Moderate indicates 125 Leuko/mcL and Large indicates 500 Leuko/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline:Leukocyte esterase,Negative,n=22
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline:Leukocyte esterase,Trace,n=22
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline:Leukocyte esterase,Small,n=22
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline:Leukocyte esterase,Moderate,n=22
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Baseline:Leukocyte esterase,Large,n=22
|
11 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 3:Leukocyte esterase,Negative,n=22
|
19 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 3:Leukocyte esterase,Small,n=22
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 3:Leukocyte esterase,Moderate,n=22
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 5:Leukocyte esterase,Negative,n=21
|
16 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 5:Leukocyte esterase,Trace,n=21
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Day 5:Leukocyte esterase,Small,n=21
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Days 10 to 13:Leukocyte esterase,Negative,n=20
|
19 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase
Days 10 to 13:Leukocyte esterase,Trace,n=20
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Urine samples were collected at indicated time points to analyze parameter including occult blood by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Small indicates 25 Erythrocytes per microliter (Ery/mcL), Moderate indicates 50 Ery/mcL and Large indicates 250 Ery/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline:Occult blood,Negative,n=22
|
6 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline:Occult blood,Small,n=22
|
10 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline:Occult blood,Moderate,n=22
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Baseline:Occult blood,Large,n=22
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 3:Occult blood,Negative,n=22
|
19 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 3:Occult blood,Small,n=22
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 3:Occult blood,Moderate,n=22
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 3:Occult blood,Large,n=22
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5:Occult blood,Negative,n=21
|
17 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5:Occult blood,Small,n=21
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Day 5:Occult blood,Moderate,n=21
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Days 10 to 13:Occult blood,Negative,n=20
|
18 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Occult Blood
Days 10 to 13:Occult blood,Small,n=20
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)Population: Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Urine samples were collected at indicated time points to analyze parameter including protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative indicates \<10 mg/dL, 1+ indicates 30 mg/dL and 2+ indicates 100 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.
Outcome measures
| Measure |
Gepotidacin 1500 mg
n=22 Participants
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Baseline: Protein,Negative,n=22
|
11 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Baseline: Protein,1+,n=22
|
10 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Baseline: Protein,2+,n=22
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Day 3: Protein,Negative,n=22
|
18 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Day 3: Protein,1+,n=22
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Day 5: Protein,Negative,n=21
|
16 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Day 5: Protein,1+,n=21
|
5 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Days 10 to 13: Protein,Negative,n=20
|
18 Participants
|
|
Number of Participants With Urinalysis Dipstick Results: Protein
Days 10 to 13: Protein,1+,n=20
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 31Population: Safety Population. This analysis was planned but data was not collected and captured in the database.
Physical examinations included assessments of the respiratory, cardiovascular, abdominal, gastrointestinal, neurological and urogenital systems. This analysis was planned but data was not collected and captured in the database.
Outcome measures
Outcome data not reported
Adverse Events
Gepotidacin 1500 mg
Serious adverse events
| Measure |
Gepotidacin 1500 mg
n=22 participants at risk
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Psychiatric disorders
Major depression
|
4.5%
1/22 • Number of events 1 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
Other adverse events
| Measure |
Gepotidacin 1500 mg
n=22 participants at risk
All participants received gepotidacin 1500 mg (2\*750 mg, tablets), BID, orally on Day 1 to Day 5. The total daily dose received was 3000 mg. All doses were administered after food consumption and with water.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
81.8%
18/22 • Number of events 22 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
|
Gastrointestinal disorders
Nausea
|
77.3%
17/22 • Number of events 18 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
|
Gastrointestinal disorders
Vomiting
|
22.7%
5/22 • Number of events 5 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.1%
2/22 • Number of events 2 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
9.1%
2/22 • Number of events 2 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
|
Nervous system disorders
Headache
|
22.7%
5/22 • Number of events 5 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • Number of events 2 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
|
General disorders
Chest discomfort
|
9.1%
2/22 • Number of events 2 • Non-SAEs and SAEs were collected from start of the treatment (Day 1) up to Day 31
Safety Population consisted of all participants who received at least 1 dose of gepotidacin.
|
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