A Clinical Trial to Evaluate the Effects of MK-4646 on Rosuvastatin in Healthy Participants (MK-4646-007)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: MK-4646; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07785830

4646-007

MK-4646-007 (Other Identifier)

Details and patient eligibility

About

Researchers are looking for new treatments for people living with HIV-1 (Human Immunodeficiency Virus Type 1). HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.

MK-4646 is a trial medicine designed to treat HIV-1. Before giving a trial medicine to people with a health condition, researchers first do studies in healthy participants.

The goals of this trial are to learn:

• What happens to rosuvastatin in a participant's body over time when it is taken with MK-4646
• About the safety of MK-4646 when taken with rosuvastatin and if people tolerate it. Tolerate means participants will receive trial medicine in the trial unless they need to stop it due to health problems.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is in good health before randomization
• Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion criteria

• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer (malignancy)
• Has a history or presence of myopathy or rhabdomyolysis (with or without prior statin therapy)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Treatment A: Rosuvastatin

Active Comparator group

Description:

Participants will receive a single oral dose of rosuvastatin.

Treatment:

Drug: Rosuvastatin

Treatment B: Rosuvastatin + MK-4646

Experimental group

Description:

Participants will receive a single oral dose of rosuvastatin coadministered with MK-4646.

Treatment:

Drug: Rosuvastatin

Drug: MK-4646