drugset / Trial / NCT06551623
Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin
Non-randomizedParallel-groupOpen-labelBasic science
Summary
This is a single center, open label, drug-drug interaction, Phase 1 study of TNP-2198 in approximately 32 healthy participants, includes 2 cohorts (16 participants per cohort): Midazolam cohort and Clarithromycin cohort. Midazolam cohort will evaluate the effect of multiple oral doses of TNP-2198 capsules on the pharmacokinetics (PK) parameters of a single oral dose of midazolam, a cytochrome P-450 (CYP) 3A sensitive substrate, in healthy participants; Clarithromycin cohort will evaluate the effect of multiple oral doses of clarithromycin tablets, a strong CYP3A and P-gp inhibitor, on the PK parameters of multiple oral doses of TNP-2198 in healthy participants.
Timeline
- Start
- 2024-08-26
- Primary completion
- 2024-10-14
- Completion
- 2024-10-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clarithromycin | Small molecule | 0.5 g | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Rifasutenizol | Small molecule | 400 mg | Oral |