HealthyPhase 1NCT07785830
A Clinical Trial to Evaluate the Effects of MK-4646 on Rosuvastatin in Healthy Participants (MK-4646-007)
A Phase 1 study testing Rosuvastatin and MK-4646 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin and MK-4646
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 10 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health before randomization
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
QPS-MRA, LLC ( Site 0002)
South Miami, Florida, 33143
About this study
Official title: An Open-Label, Crossover Study to Evaluate the Effects of a Single Dose of MK-4646 on Single Dose Pharmacokinetics of Rosuvastatin in Healthy Participants
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.
Read more
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
- Being tested
- Rosuvastatin, MK-4646
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Oral tablet
MK-4646Drug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Rosuvastatin | Active comparator | Participants will receive a single oral dose of rosuvastatin. Receives: Drug: Rosuvastatin |
| Treatment B: Rosuvastatin + MK-4646 | Experimental | Participants will receive a single oral dose of rosuvastatin coadministered with MK-4646. Receives: Drug: Rosuvastatin; Drug: MK-4646 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start25 Sep 2026
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785830
- Sponsor's protocol ID
- 4646-007
- Other IDs
- MK-4646-007
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Crossover Study to Evaluate the Effects of a Single Dose of MK-4646 on Single Dose Pharmacokinetics of Rosuvastatin in Healthy Participants
- ClinicalTrials.gov ID
- NCT07785830
- Acronym / sponsor ID
- 4646-007
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Rosuvastatin | Active comparator | Drug: RosuvastatinParticipants will receive a single oral dose of rosuvastatin. |
| Treatment B: Rosuvastatin + MK-4646 | Experimental | Drug: Rosuvastatin, Drug: MK-4646Participants will receive a single oral dose of rosuvastatin coadministered with MK-4646. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health before randomization
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinOral tablet | Drug | Treatment A: Rosuvastatin, Treatment B: Rosuvastatin + MK-4646 |
| MK-4646Oral capsule | Drug | Treatment B: Rosuvastatin + MK-4646 |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin
Time frame: 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
Time frame: 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.
8 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 26 days
Number of Participants Who Discontinue Study Treatment Due to an AE
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
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
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
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
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
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
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin and MK-4646 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Rosuvastatin When MK-4646 is Coadministered with Rosuvastatin (time frame: At designated timepoints (up to approximately 72 hours post dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.