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Clinical Trials in the USA / NCT07785830
Starting soon Phase 1

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

NCT07785830 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1
Started
2026-09-25
Last updated
2026-10-05

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Rosuvastatin →MK-4646

Rosuvastatin: Oral tablet

MK-4646: Oral capsule

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin — At designated timepoints (up to approximately 72 hours post dose)
    Blood samples will be collected to determine the AUC0-Inf of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
  • Maximum Plasma Concentration (Cmax) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin — At designated timepoints (up to approximately 72 hours post dose)
    Blood samples will be collected to determine the Cmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin.

Trial sites (1)

FacilityCityRegionStatus
QPS-MRA, LLC ( Site 0002) South Miami Florida

On this site

📄 Crestor (rosuvastatin) drug profile →

More Merck Sharp & Dohme LLC trials in the USA

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) Recruiting
A Clinical Trial of Nemtabrutinib in Participants With Severe Kidney Disease (MK-1026-027) Recruiting
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) Recruiting
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) Active, not recruiting
A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01) Recruiting

Other trials for the same condition

A Clinical Trial of Nemtabrutinib in Participants With Severe Kidney Disease (MK-1026-027) Recruiting
A Study of LY4515100 in Healthy Participants Recruiting
A Study of V132 in Healthy Older Participants (V132-001) Recruiting
A Study of LY4088044 in Healthy Participants Recruiting
A Study of Mirikizumab Solution (LY3074828) in Healthy Participants Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07785830 on ClinicalTrials.gov ↗ ← All trials in the USA