drugset / Trial / NCT04319718
Safety and Pharmacokinetics of Two Vaginal Film Formulations Containing the Integrase Inhibitor MK-2048
Phase 1
Completed
37 enrolled
Hillier, Sharon, PhD
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
This is a proof of concept study to determine whether an extended release vaginal film can deliver drug for seven days. Two film formulations containing MK-2048 which differ by dissolution and spreadability attributes will be compared for safety and pharmacokinetic outcomes.
Timeline
- Start
- 2020-08-19
- Primary completion
- 2022-02-25
- Completion
- 2022-10-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-2048 | Unknown | 30 mg | Other |
Indications
No indication recorded.