A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)
Launched by MERCK SHARP & DOHME LLC · Jul 3, 2025
Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medicine called MK-8527, which is being developed to help prevent HIV-1 infection. HIV-1 is the most common type of HIV, a virus that attacks the immune system. Unlike current prevention methods that require daily pills or frequent injections, MK-8527 is designed to be taken as a tablet once a month, which might make it easier for some people to use. This early-phase study aims to see if taking a higher dose of MK-8527 affects the heart’s rhythm, specifically by measuring something called the QT interval, which helps doctors understand how the heart is beating.
The study is looking for healthy adults to participate. To be eligible, participants should be in good health and have a body weight within a certain range (measured by a BMI between 18 and 32). People with certain health problems, including serious illnesses or infections like hepatitis or HIV, won’t be able to join. If you take part, you can expect careful monitoring of your heart and overall health to see how the medicine affects you. This study is not yet recruiting, but it will include adults of all genders who meet the health requirements.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- 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
- Exclusion Criteria:
- 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).
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported