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Drug-drug Interaction Study of Gepotidacin

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ClinicalTrials.gov Identifier: NCT04493931
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.

Condition or disease Intervention/treatment Phase
Bacterial Infections Infections, Bacterial Drug: Gepotidacin Drug: Cimetidine Drug: Rifampicin Drug: Midazolam Drug: Digoxin Other: Placebo matching to gepotidacin Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cohort 1 and 2 are open-label, fixed sequence DDI cohorts. Cohort 3 is an open-label, 2-sequence, 2-period crossover randomized DDI cohort. Cohort 4 is a double-blind, placebo-controlled, randomized sequence study to investigate the safety and PK of gepotidacin.
Masking: Double (Participant, Investigator)
Masking Description: Cohort 1 to 3 are open-label cohorts. Cohort 4 is a double-blind cohort which contains blinded treatment of gepotidacin and placebo.
Primary Purpose: Treatment
Official Title: A Pharmacokinetic, Multi-cohort Study in Healthy Adult Subjects to Assess Gepotidacin as Victim and as Perpetrator of Drug-Drug Interactions Via CYP450, Renal and Intestinal Transporters, and to Assess Gepotidacin Pharmacokinetics in Japanese Healthy Adults
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : November 27, 2020
Estimated Study Completion Date : November 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg
This is a fixed sequence (Sequence AB) cohort. Participants will receive gepotidacin 1500 milligrams (mg) single dose (SD) on Day 1 of Period 1 (Treatment A); and Cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 and gepotidacin 1500 mg single dose (Treatment B). Gepotidacin will be administered 1 hour after the first dose of cimetidine on Day 2 of Period 2. There will be a washout of at least 3 days between Treatment A and Treatment B, and a follow-up visit 5 to 7 days after the last dose of cimetidine.
Drug: Gepotidacin
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
Other Name: GSK2140944

Drug: Cimetidine
Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.

Experimental: Cohort 2: Gepotidacin 1500 mg + Rifampicin 600 mg
This is a fixed sequence (Sequence CDE) cohort. Participants will receive gepotidacin 1500 mg single dose on Day 1 of Period 1 (Treatment C), rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7 of Period 2, to elicit maximal enzyme induction) (Treatment D); and gepotidacin 1500 mg single dose administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2 (Treatment E). There will be a washout of at least 3 days between Treatment C and Treatment D, and a follow-up visit 7 to 10 days after the last dose of rifampicin.
Drug: Gepotidacin
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
Other Name: GSK2140944

Drug: Rifampicin
Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.

Experimental: Cohort 3: Digoxin 0.5mg+Midazolam 2mg then Gepotidacin 3000mg
Participants will receive digoxin 0.5 mg and midazolam 2 mg (Treatment F) in Period 1 on Day 1 then gepotidacin two 3000 mg doses (given 12 hours apart) co-administered with digoxin 0.5 mg and midazolam 2 mg in Period 2 on Day 1, with the 2 probe drugs administered with the second daily dose of gepotidacin only (Treatment G). There will be a washout of at least 10 days between treatments. In Sequence 2, these regimens are reversed. A follow-up visit will occur 7 to 10 days after the last dose of study intervention in Period 2.
Drug: Gepotidacin
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
Other Name: GSK2140944

Drug: Midazolam
Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.

Drug: Digoxin
Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.

Experimental: Cohort 3: Gepotidacin 3000mg then Digoxin 0.5mg+Midazolam 2mg
Participants will receive gepotidacin two 3000 mg doses (given 12 hours apart) co-administered with digoxin 0.5 mg and midazolam 2 mg in Period 1 on Day 1, with the 2 probe drugs administered with the second daily dose of gepotidacin only (Treatment G) followed by digoxin 0.5 mg and midazolam 2 mg (Treatment F) in Period 2 on Day 1. A follow-up visit will occur 7 to 10 days after the last dose of study intervention in Period 2.
Drug: Gepotidacin
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
Other Name: GSK2140944

Drug: Midazolam
Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.

Drug: Digoxin
Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.

Experimental: Cohort 4: Gepotidacin 1500 mg fed then fasted then 3000 mg fed
Cohort 4 will include Japanese participants. Participants will receive a single dose of gepotidacin 1500 mg under fed conditions in Period 1 (Treatment H), then a single dose of gepotidacin 1500 mg under fasted conditions in Period 2 (Treatment I), followed by two doses of gepotidacin up to 3000 mg (given 12 hours apart) under fed conditions in Period 3 (Treatment J). There will be a washout of at least 3 days between each treatment, and a follow-up visit 5 to 7 days after the last dose of gepotidacin.
Drug: Gepotidacin
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
Other Name: GSK2140944

Experimental: Cohort 4: Gepotidacin 1500 mg fasted then fed then 3000 mg fed
Cohort 4 will include Japanese participants. Participants will receive a single dose of gepotidacin 1500 mg under fasted conditions in Period 1 (Treatment I), then a single dose of gepotidacin 1500 mg under fed conditions in Period 2 (Treatment H), followed by two doses of gepotidacin up to 3000 mg (given 12 hours apart) under fed conditions in Period 3 (Treatment J). There will be a washout of at least 3 days between each treatment, and a follow-up visit 5 to 7 days after the last dose of gepotidacin.
Drug: Gepotidacin
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
Other Name: GSK2140944

Placebo Comparator: Cohort 4: Placebo fed then fasted then fed
Cohort 4 will include Japanese participants. Participants will receive a single dose of placebo under fed conditions in Period 1, then a single dose of placebo under fasted conditions in Period 2, followed by two doses of placebo (given 12 hours apart) under fed conditions in Period 3. There will be a washout of at least 3 days between each period, and a follow-up visit 5 to 7 days after the last dose of placebo.
Other: Placebo matching to gepotidacin
Placebo matching to gepotidacin tablets will be administered orally.

Placebo Comparator: Cohort 4: Placebo fasted then fed then fed
Cohort 4 will include Japanese participants. Participants will receive a single dose of placebo under fasted conditions in Period 1, then a single dose of placebo under fed conditions in Period 2, followed by two doses of placebo (given 12 hours apart) under fed conditions in Period 3. There will be a washout of at least 3 days between each period, and a follow-up visit 5 to 7 days after the last dose of placebo.
Other: Placebo matching to gepotidacin
Placebo matching to gepotidacin tablets will be administered orally.




Primary Outcome Measures :
  1. Cohort 1: Maximum observed concentration (Cmax) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  2. Cohort 1: Time to reach maximum observed plasma concentration (Tmax) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  3. Cohort 1: Terminal phase half-life (t1/2) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  4. Cohort 1: Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC [0-t]) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  5. Cohort 1: AUC from time 0 (predose) extrapolated to infinite time (AUC[0-infinity]) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  6. Cohort 2: Cmax of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  7. Cohort 2: Lag time before observation of drug concentrations (Tlag) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  8. Cohort 2: Tmax of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  9. Cohort 2: AUC(0-t) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  10. Cohort 2: AUC(0-infinity) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  11. Cohort 3: Cmax of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  12. Cohort 3: Tlag of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  13. Cohort 3: Tmax of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  14. Cohort 3: AUC(0-t) of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  15. Cohort 3: AUC(0-infinity) of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  16. Cohort 3: Cmax of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  17. Cohort 3: Tlag of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  18. Cohort 3: Tmax of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  19. Cohort 3: AUC(0-t) of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  20. Cohort 3: AUC(0-infinity) of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  21. Cohort 4: Cmax of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  22. Cohort 4: Tmax of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  23. Cohort 4: AUC from time 0 (predose) to 24 hours post dose administration (AUC [0-24]) of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 24 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  24. Cohort 4: AUC from time 0 (predose) to 48 hours post dose administration (AUC [0-48]) of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  25. Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  26. Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  27. Cohort 4: Cmax of gepotidacin after the first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  28. Cohort 4: Tmax of gepotidacin after the first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  29. Cohort 4: AUC from time 0 (predose) to time tau (AUC[0-tau]) of gepotidacin after the first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  30. Cohort 4: Cmax of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of evening dose up to 48 hours post evening dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  31. Cohort 4: Tmax of gepotidacin after the second dose of 3000 mg gepotidacin (evening dose) [ Time Frame: From start of evening dose up to 48 hours post evening dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  32. Cohort 4: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of evening dose up to 48 hours post evening dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  33. Cohort 4: Accumulation ratio for Cmax (RoCmax) of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of morning dose up to 48 hours post evening dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  34. Cohort 4: Accumulation ratio for AUC (RoAUC) of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of morning dose up to 48 hours post evening dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  35. Cohort 4: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 24 hours post morning dose (first dose) in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  36. Cohort 4: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 48 hours post morning dose (first dose) in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  37. Cohort 4: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  38. Cohort 4: Number of participants with non-serious adverse events (non-SAEs) [ Time Frame: Up to Day 16 ]
    AEs will be collected.

  39. Cohort 4: Number of participants with serious adverse events (SAEs) [ Time Frame: Up to Day 16 ]
    SAEs will be collected.

  40. Cohort 4: Number of participants with abnormal vital signs [ Time Frame: Up to Day 16 ]
    Number of participants with abnormal vital signs will be assessed.

  41. Cohort 4: Number of participants with abnormal electrocardiogram (ECG) findings [ Time Frame: Up to Day 16 ]
    Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

  42. Cohort 4: Number of participants with abnormal hematology parameters [ Time Frame: Up to Day 16 ]
    Blood samples will be collected for the assessment of hematology parameters.

  43. Cohort 4: Number of participants with abnormal clinical chemistry parameters [ Time Frame: Up to Day 16 ]
    Blood samples will be collected for the assessment of chemistry parameters.

  44. Cohort 4: Number of participants with abnormal urinalysis findings [ Time Frame: Up to Day 16 ]
    Urine samples will be collected for the assessment of urinalysis parameters.

  45. Cohort 4: Cmax of gepotidacin after a single 1500 mg dose under fed conditions [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  46. Cohort 4: Tlag of gepotidacin after a single 1500 mg dose under fed conditions [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  47. Cohort 4: Tmax of gepotidacin after a single 1500 mg dose under fed conditions [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  48. Cohort 4: AUC(0-t) of gepotidacin after a single 1500 mg dose under fed conditions [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  49. Cohort 4: AUC(0-infinity) of gepotidacin after a single 1500 mg dose under fed conditions [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.


Secondary Outcome Measures :
  1. Cohort 1: AUC(0-24) of gepotidacin [ Time Frame: Up to 24 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  2. Cohort 1: AUC(0-48) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  3. Cohort 1: Tlag of a gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  4. Cohort 1: Apparent volume of distribution (Vz/F) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  5. Cohort 1: Apparent oral clearance (CL/F) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  6. Cohort 1: Total unchanged drug (Ae total) of gepotidacin in urine [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  7. Cohort 1: AUC(0-24) of gepotidacin in urine [ Time Frame: Up to 24 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  8. Cohort 1: AUC(0-48) of gepotidacin in urine [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  9. Cohort 1: Renal clearance of drug (CLr) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  10. Cohort 1: Amount of drug excreted in urine in a time interval (Ae[t1-t2]) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  11. Cohort 1: Percentage of the given dose of drug excreted in urine (fe%) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  12. Cohort 1: Number of participants with non-SAEs [ Time Frame: Up to Day 14 ]
    AEs will be collected.

  13. Cohort 1: Number of participants with SAEs [ Time Frame: Up to Day 14 ]
    SAEs will be collected.

  14. Cohort 1: Number of participants with abnormal hematology parameters [ Time Frame: Up to Day 14 ]
    Blood samples will be collected for the assessment of hematology parameters.

  15. Cohort 1: Number of participants with abnormal clinical chemistry parameters [ Time Frame: Up to Day 14 ]
    Blood samples will be collected for the assessment of chemistry parameters.

  16. Cohort 1: Number of participants with abnormal urinalysis findings [ Time Frame: Up to Day 14 ]
    Urine samples will be collected for the assessment of urinalysis parameters.

  17. Cohort 1: Number of participants with abnormal vital signs [ Time Frame: Up to Day 14 ]
    Number of participants with abnormal vital signs will be assessed.

  18. Cohort 1: Number of participants with abnormal ECG findings [ Time Frame: Up to Day 14 ]
    Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

  19. Cohort 2: AUC(0-24) of gepotidacin [ Time Frame: Up to 24 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  20. Cohort 2: AUC(0-48) of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  21. Cohort 2: T1/2 of a gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  22. Cohort 2: Vz/F of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  23. Cohort 2: CL/F of gepotidacin [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  24. Cohort 2: Ae total of gepotidacin in urine [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  25. Cohort 2: AUC(0-24) of gepotidacin in urine [ Time Frame: Up to 24 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  26. Cohort 2: AUC(0-48) of gepotidacin in urine [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  27. Cohort 2: CLr of gepotidacin in urine [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  28. Cohort 2: Ae(t1-t2) of gepotidacin in urine [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  29. Cohort 2: fe% of gepotidacin in urine [ Time Frame: Up to 48 hours post dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  30. Cohort 2: Number of participants with non-SAEs [ Time Frame: Up to Day 20 ]
    AEs will be collected.

  31. Cohort 2: Number of participants with SAEs [ Time Frame: Up to Day 20 ]
    SAEs will be collected.

  32. Cohort 2: Number of participants with abnormal hematology parameters [ Time Frame: Up to Day 20 ]
    Blood samples will be collected for the assessment of hematology parameters.

  33. Cohort 2: Number of participants with abnormal clinical chemistry parameters [ Time Frame: Up to Day 20 ]
    Blood samples will be collected for the assessment of chemistry parameters.

  34. Cohort 2: Number of participants with abnormal urinalysis findings [ Time Frame: Up to Day 20 ]
    Urine samples will be collected for the assessment of urinalysis parameters.

  35. Cohort 2: Number of participants with abnormal vital signs [ Time Frame: Up to Day 20 ]
    Number of participants with abnormal vital signs will be assessed.

  36. Cohort 2: Number of participants with abnormal ECG findings [ Time Frame: Up to Day 20 ]
    Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG parameters will be assessed.

  37. Cohort 3: Cmax of gepotidacin after the first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  38. Cohort 3: Tmax of gepotidacin after the first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  39. Cohort 3: Tlag of gepotidacin after the first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  40. Cohort 3: AUC(0-tau) of gepotidacin first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  41. Cohort 3: Cmax of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of evening dose up to 48 hours post evening dose in each Period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  42. Cohort 3: Tmax of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of evening dose up to 48 hours post evening dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  43. Cohort 3: RoCmax of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of morning dose up to 48 hours post evening dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  44. Cohort 3: RoAUC of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of morning dose up to 48 hours post evening dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  45. Cohort 3: AUC(0-tau) of gepotidacin after the second dose of 3000 mg (evening dose) [ Time Frame: From start of evening dose up to 48 hours post evening dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  46. Cohort 3: AUC(0-24) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 24 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  47. Cohort 3: AUC(0-48) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 48 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  48. Cohort 3: AUC(0-t) of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  49. Cohort 3: Vz/Fof gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  50. Cohort 3: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  51. Cohort 3: T1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  52. Cohort 3: Trough concentration (Cmin) of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  53. Cohort 3: t1/2 of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  54. Cohort 3: Vz/F of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  55. Cohort 3: CL/F of digoxin [ Time Frame: Up to 96 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of digoxin.

  56. Cohort 3: Cmin of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  57. Cohort 3: t1/2 of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  58. Cohort 3: Vz/F of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  59. Cohort 3: CL/F of midazolam [ Time Frame: Up to 48 hours post dose in each period ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of midazolam.

  60. Cohort 3: Ae total of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  61. Cohort 3: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  62. Cohort 3: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  63. Cohort 3: AUC(0-24) of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 24 hours post morning dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  64. Cohort 3: AUC(0-48) of gepotidacin in urine following two 3000 mg doses (urine) [ Time Frame: From start of morning dose up to 48 hours post morning dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  65. Cohort 3: fe% of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 48 hours post morning dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  66. Cohort 3: CLr of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in each period ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  67. Cohort 3: Number of participants with non-SAEs [ Time Frame: Up to Day 30 ]
    AEs will be collected.

  68. Cohort 3: Number of participants with SAEs [ Time Frame: Up to Day 30 ]
    SAEs will be collected.

  69. Cohort 3: Number of participants with abnormal hematology parameters [ Time Frame: Up to Day 30 ]
    Blood samples will be collected for the assessment of hematology parameters.

  70. Cohort 3: Number of participants with abnormal clinical chemistry parameters [ Time Frame: Up to Day 30 ]
    Blood samples will be collected for the assessment of chemistry parameters.

  71. Cohort 3: Number of participants with abnormal urinalysis [ Time Frame: Up to Day 30 ]
    Urine samples will be collected for the assessment of urinalysis parameters.

  72. Cohort 3: Number of participants with abnormal vital signs [ Time Frame: Up to Day 30 ]
    Number of participants with abnormal vital signs will be assessed.

  73. Cohort 3: Number of participants with abnormal ECG findings [ Time Frame: Up to Day 30 ]
    Single 12-lead ECG will be obtained using an ECG machine. Number of participants with abnormal ECG findings will be assessed.

  74. Cohort 4: T1/2 of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  75. Cohort 4: Vz/F of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  76. Cohort 4: CL/F of gepotidacin after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  77. Cohort 4: Tlag of gepotidacin after the first dose of 3000 mg (morning dose) [ Time Frame: Up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  78. Cohort 4: Vz/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  79. Cohort 4: CL/F of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  80. Cohort 4: t1/2 of gepotidacin using the full profile (morning + evening doses) following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Blood samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  81. Cohort 4: Ae total of gepotidacin in urine after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  82. Cohort 4: Ae(t1-t2) of gepotidacin in urine after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  83. Cohort 4: AUC(0-tau) of gepotidacin in urine after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  84. Cohort 4: AUC(0-24) of gepotidacin in urine after a single 1500 mg dose [ Time Frame: Up to 24 hours post dose in Period 1 and Period 2 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  85. Cohort 4: AUC(0-48) of gepotidacin in urine after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  86. Cohort 4: fe% of gepotidacin in urine after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  87. Cohort 4: CLr of gepotidacin in urine after a single 1500 mg dose [ Time Frame: Up to 48 hours post dose in Period 1 and Period 2 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  88. Cohort 4: Ae total of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  89. Cohort 4: Ae(t1-t2) of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  90. Cohort 4: AUC(0-tau) of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  91. Cohort 4: AUC(0-24) of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 24 hours post morning dose in Period 3 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  92. Cohort 4: AUC(0-48) of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 48 hours post morning dose in Period 3 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  93. Cohort 4: fe% of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.

  94. Cohort 4: CLr of gepotidacin in urine following two 3000 mg doses [ Time Frame: From start of morning dose up to 60 hours post morning dose in Period 3 ]
    Urine samples will be collected at indicated time points for the pharmacokinetic analysis of gepotidacin.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must be greater than or equal to (>=) 18 to less than or equal to (=<) 50 years of age inclusive, at the time of signing the informed consent.
  • Participants who are healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECG results. A participant with clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Additional inclusion criteria for Japanese participants (Cohort 4): The participant is a non-naturalized Japanese citizen and holds a Japanese passport (current or expired).

The participant has/had 2 Japanese parents and 4 Japanese grandparents who are/were all non-naturalized Japanese citizens, as confirmed by interview.

The participant has been living outside of Japan for up to 10 years as confirmed by interview.

  • Participants have a body weight >=40 kg and body mass index within the range 18.5 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
  • Male and/or female: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    1. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies: Is a woman of non-childbearing potential or Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1 percent (%), for at least 30 days prior to dosing until completion of the follow-up Visit. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.

A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention and for women not on effective contraception at least 14 days prior to baseline visit.

The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Exclusion Criteria:

  • Clinically significant abnormality in the past medical history or at the screening physical examination that in the investigator's opinion may place the participant at risk or interfere with the outcome variables of the study. This includes, but is not limited to, history or current cardiac, hepatic, renal, neurologic, gastro-intestinal (GI), respiratory, hematologic, or immunologic disease.
  • Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention, or any other condition that may place the participant at risk, in the opinion of the investigator.
  • Female participant has a positive pregnancy test result or is lactating at Screening or upon admission to the clinic.
  • Positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Note: Testing will be performed according to site procedures.
  • Within 2 months before Screening, either a confirmed history of Clostridium difficile (C. difficile) diarrhea infection or a past positive of C. difficile toxin test.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • History of drug and/or alcohol abuse within 6 months before Screening, as determined by the investigator, or has a positive drug screen at Screening or upon admission to the clinic.
  • History of sensitivity/hypersensitivity to any of the study drugs, components thereof, or a history of drug or other allergy that, in the opinion of the Investigator or GlaxoSmithKline (GSK) Medical Monitor contraindicates their participation.
  • Cohort 2 Only: Participant is a contact lens wearer who is unable or unwilling to wear glasses for the duration of the study and for 5 half-lives after the last dose of rifampicin.
  • Use of any systemic antibiotic within 30 days of screening.
  • Participants must abstain from taking prescription or non-prescription drugs (except for hormonal contraceptives and/or acetaminophen at doses of <=2 grams/day), vitamins, and dietary or herbal supplements, within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to study intervention until completion of the follow-up Visit, unless, in the opinion of the investigator and Sponsor, the medication will not interfere with the study. Any exceptions will be discussed with the Sponsor or Medical Monitor on a case-by-case basis and the reasons will be documented.
  • Previous exposure to gepotidacin.
  • Participant has participated in a clinical trial and has received an investigational product (IP) prior to gepotidacin administration within 30 days, 5 half-lives, or twice the duration of the biological effect of IP (whichever is longer).
  • Past participation in this clinical study.
  • Baseline corrected QT interval using the Fridericia formula (QTcF) of >450 milliseconds (msec) at Screening or Check-in.
  • Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention.
  • Alanine aminotransferase (ALT) >1.5 times upper limit of normal (ULN) at Screening or Check-in.
  • Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at Screening or Check-in.
  • History of any kidney disease or current or chronic history of mild impaired renal function as indicated by an estimated creatinine clearance <=90 milliliters per minute (mL/min).
  • A positive test for human immunodeficiency virus (HIV) antibody.
  • History of regular alcohol consumption within 6 months of Screening defined as an average weekly intake of >21 units (or an average daily intake of >3 units) for males or an average weekly intake of >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer, 30 mL of spirits, or 100 mL of wine.
  • Cohort 3 Only: Digoxin-related exclusions include the following at Screening:

Serum potassium >5.5 milliequivalent per liter (mEq/L) or < 3.6 mEq/L Serum magnesium <1.6 milligrams per deciliter (mg/dL) Serum calcium (total) <8.5 mg/dL History of hypersensitivity to digoxin or other digitalis glycosides Any clinically relevant abnormality on 12-lead ECG at Screening or Check-in.

  • Participant has donated blood in excess of 500 mL within 12 weeks prior to dosing or participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
  • Participant is unable to comply with all study procedures, in the opinion of the investigator.
  • Participant should not participate in the study, in the opinion of the investigator or Sponsor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493931


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Nevada
GSK Investigational Site Recruiting
Las Vegas, Nevada, United States, 89113
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Darin Brimhall         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04493931    
Other Study ID Numbers: 213678
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Gepotidacin
Drug Interaction
Pharmacokinetic
Safety
Bacterial Infection
Japanese Healthy Adults
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Rifampin
Digoxin
Midazolam
Cimetidine
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers