Could a new HIV drug change how statins work?
NCT ID NCT07785830
First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a single dose of an experimental HIV medicine called MK-4646 changes how the body processes rosuvastatin, a widely used cholesterol-lowering statin. Healthy volunteers will receive both drugs in a crossover design, and researchers will measure rosuvastatin levels in the blood and monitor safety. The goal is to understand potential drug interactions before studying MK-4646 in people living with HIV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MK-4646 (an experimental oral capsule for HIV-1) taken together with rosuvastatin (an oral statin tablet)
- What this could lead to
- If this interaction is safe, it could help guide how MK-4646 is used with common statins in future HIV treatment plans.
- What could go wrong
- This is a small, early-stage study in healthy people, not in those with HIV. Results may not predict effects in patients, and there is a risk of unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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