A Study of Rifabutin and MK-4646 in Healthy Participants (MK-4646-004)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rifabutin; Drug: MK-4646

Study type: Interventional

Funder types: Industry

Identifiers

NCT07199452

MK-4646-004 (Other Identifier)

4646-004

Details and patient eligibility

About

Researchers have designed a new study medicine called MK-4646 as a new way to treat human immunodeficiency virus (HIV). Rifabutin is a medication used to treat tuberculosis (TB).

Researchers want to learn about MK-4646 when taken at the same time as Rifabutin.

They want to:

Measure a person's blood to find out if the amount of MK-4646 in the blood is the same when MK-4646 is taken alone or with Rifabutin Learn about the safety of MK-4646 when taken alone or with Rifabutin and if people tolerate it

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion criteria include but are not limited to:

• Is in good health
• Has a body-mass index (BMI) between 18 and 32 kg/m2

The main exclusion criteria include but are not limited to:

• Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer (malignancy)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

MK-4646

Experimental group

Description:

On Period 1 Day 1, a single oral dose of MK-4646 will be administered.

Treatment:

Drug: MK-4646

MK-4646 with Rifabutin

Experimental group

Description:

Rifabutin will be administered orally once daily from Period 2 Day 1 through Period 2 Day 16. A single oral dose of MK-4646 will be administered on Period 2 Day 14.

Treatment:

Drug: MK-4646

Drug: Rifabutin