drugset / Trial / NCT04493931
Drug-drug Interaction Study of Gepotidacin
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2020-08-14
- Primary completion
- 2020-12-21
- Completion
- 2020-12-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cimetidine | Small molecule | 400 mg | Oral |
| Subject | Digoxin | Other / unclassified | 0.5 mg | Oral |
| Subject | Gepotidacin | Small molecule | 1500 mg | Oral |
| Subject | Gepotidacin | Small molecule | 3000 mg | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Rifampin | Small molecule | 600 mg | Oral |