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

NCT07785830 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 4646-007MK-4646-007
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

  Blood samples will be collected to determine the AUC0-Inf of rosuvastatin when MK-4646 is coadministered with rosuvastatin.

  At designated timepoints (up to approximately 72 hours post dose)

• Maximum Plasma Concentration (Cmax) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

  Blood samples will be collected to determine the Cmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin.

  At designated timepoints (up to approximately 72 hours post dose)

Secondary Outcomes (8)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 26 days

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 9 days

• Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

  At designated timepoints (up to approximately 72 hours post dose)

• Area Under the Concentration-Time Curve from Time 0 to 24 (AUC0-24) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

  At designated timepoints (up to approximately 72 hours post dose)

• Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin

  At designated timepoints (up to approximately 72 hours post dose)

Study Arms (2)

Treatment A: Rosuvastatin

ACTIVE COMPARATOR

Participants will receive a single oral dose of rosuvastatin.

Drug: Rosuvastatin

Treatment B: Rosuvastatin + MK-4646

EXPERIMENTAL

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

Drug: Rosuvastatin; Drug: MK-4646

Interventions

Rosuvastatin DRUG

Oral tablet

Treatment A: Rosuvastatin; Treatment B: Rosuvastatin + MK-4646

MK-4646 DRUG

Oral capsule

Treatment B: Rosuvastatin + MK-4646

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 25, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share