A Phase 1 interventional study of Rosuvastatin and MK-4646 in Healthy, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Basic science
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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:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single oral dose of rosuvastatin.
Drug: Rosuvastatin
Participants will receive a single oral dose of rosuvastatin coadministered with MK-4646.
Drug: Rosuvastatin · Drug: MK-4646
Oral tablet
Oral capsule
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.
Time frame: 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.
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 26 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: 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
Blood samples will be collected to determine the AUC0-last of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Time frame: 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
Blood samples will be collected to determine the AUC0-24 of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Time frame: 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
Blood samples will be collected to determine the Tmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin
Blood samples will be collected to determine the t½ of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Apparent Clearance (CL/F) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin
Blood samples will be collected to determine the CL/F of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Apparent Volume of Distribution (Vz/F) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin
Blood samples will be collected to determine the Vz/F of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · externaldatasharing-msd.com
Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 1 month after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: MK4646