drugset / Trial / NCT02204501
A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers
RandomizedSingle-groupOpen-labelOther
Summary
The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.
Timeline
- Start
- 2014-05
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 5 mg | Oral |
| Subject | Vapendavir | Small molecule | 264 mg | — |
| Subject | Vapendavir | Small molecule | 528 mg | — |
Indications
No indication recorded.