A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often. MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet. The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
Key facts
- Study ID
- NCT07063238
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 42
- Starts
- 2025-08-12
- Expected to finish
- 2025-12-29
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- The main inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Has body mass index (BMI) between 18 and 32 kg/m\^2, inclusive
You may not qualify if…
- The main exclusion criteria include but are not limited to the following:
- Has history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- Has history of cancer (malignancy).
- Has positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Where it is running
- Hassman Research Institute Marlton Site ( Site 0001) — Marlton, New Jersey, United States
Full record on ClinicalTrials.gov
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