A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Moxifloxacin; Drug: MK-8527

Study type: Interventional

Funder types: Industry

Identifiers

NCT07063238

MK-8527-014 (Other Identifier)

8527-014

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 3 patient groups

MK-8527 PLUS Moxifloxacin and Placebo

Experimental group

Description:

Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization.

Treatment:

Drug: MK-8527

Drug: Moxifloxacin

Drug: Placebo

Moxifloxacin PLUS MK-8527 and Placebo

Experimental group

Description:

Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization.

Treatment:

Drug: MK-8527

Drug: Moxifloxacin

Drug: Placebo

Placebo PLUS MK-8527 and Moxifloxacin

Experimental group

Description:

Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization.

Treatment:

Drug: MK-8527

Drug: Moxifloxacin

Drug: Placebo