Trials / Completed
CompletedNCT06045507
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 352 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-8527 | MK-8527 capsule |
| DRUG | Placebo to MK-8527 | Placebo capsule matched to MK-8527 |
Timeline
- Start date
- 2023-11-08
- Primary completion
- 2024-12-12
- Completion
- 2025-02-12
- First posted
- 2023-09-21
- Last updated
- 2026-01-07
- Results posted
- 2026-01-07
Locations
18 sites across 3 countries: United States, Israel, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06045507. Inclusion in this directory is not an endorsement.