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

NCT ID: NCT07199452

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-28

Study Completion Date

2026-01-07

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MK-4646

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

Group Type EXPERIMENTAL

MK-4646

Intervention Type DRUG

Oral Capsule

MK-4646 with Rifabutin

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.

Group Type EXPERIMENTAL

MK-4646

Intervention Type DRUG

Oral Capsule

Rifabutin

Intervention Type DRUG

Oral Capsule

Interventions

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MK-4646

Oral Capsule

Intervention Type DRUG

Rifabutin

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp and Dohme LLC

Locations

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Fortea CRU Madison ( Site 0001)

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-4646-004

Identifier Type: OTHER

Identifier Source: secondary_id

4646-004

Identifier Type: -

Identifier Source: org_study_id

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