HealthyPhase 1NCT07532304
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)
A Phase 1 study testing Bictegravir/emtricitabine/tenofovir alafenamide, Dolutegravir and MK4646 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. 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?
- Bictegravir/emtricitabine/tenofovir alafenamide, Dolutegravir and MK4646
- 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
- 11 May 2026to 23 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pinnacle Research Group ( Site 0001)
Anniston, Alabama, 36207
About this study
Official title: A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir
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.
HIV-1 treatments, called ART (antiretroviral therapy), involve taking medicines to lower the amount of HIV-1 virus in the body. Standard ART may include Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) and Dolutegravir (DTG).
Read more
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 trials in healthy people.
The goals of this study are to learn:
- If taking MK 4646 together with BIC/FTC/TAF or DTG changes the amount of these ARTs in the blood over time.
- About the safety of MK-4646 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
- Conditions
- Healthy
- Being tested
- Bictegravir/emtricitabine/tenofovir alafenamide, Dolutegravir, MK4646
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir/emtricitabine/tenofovir alafenamideDrug
Single oral tablet
DolutegravirDrug
Oral tablet
MK4646Drug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) | Experimental | Participants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Receives: Drug: Bictegravir/emtricitabine/tenofovir alafenamide |
| Treatment B: dolutegravir (DTG) | Experimental | Participants will receive a single oral dose of dolutegravir (DTG). Receives: Drug: Dolutegravir |
| Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) | Experimental | Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Receives: Drug: Bictegravir/emtricitabine/tenofovir alafenamide; Drug: MK4646 |
| Treatment D: MK-4646 + dolutegravir (DTG) | Experimental | Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG). Receives: Drug: Dolutegravir; Drug: MK4646 |
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-∞) of Bictegravir
Blood samples will be collected to determine the AUC0-∞ of bictegravir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Emtricitabine
Blood samples will be collected to determine the AUC0-∞ of emtricitabine.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir Alafenamide
Blood samples will be collected to determine the AUC0-∞ of tenofovir alafenamide.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir
Blood samples will be collected to determine the AUC0-∞ of tenofovir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Dolutegravir
Blood samples will be collected to determine the AUC0-∞ of dolutegravir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Secondary outcomes (22)
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 44 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 31 Days
Maximum Plasma Concentration (Cmax) of Bictegravir
Blood samples will be collected to determine the Cmax of bictegravir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at 24 Hours (C24) of Bictegravir
Blood samples will be collected to determine the C24 of bictegravir.
Measured: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Bictegravir
Blood samples will be collected to determine the Tmax of bictegravir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Bictegravir
Blood samples will be collected to determine the t½ of bictegravir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Emtricitabine
Blood samples will be collected to determine the Cmax of emtricitabine.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at 24 Hours (C24) of Emtricitabine
Blood samples will be collected to determine the C24 of emtricitabine.
Measured: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Emtricitabine
Blood samples will be collected to determine the Tmax of emtricitabine.
Measured: At designated time points (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Emtricitabine
Blood samples will be collected to determine the t½ of emtricitabine.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Tenofovir Alafenamide
Blood samples will be collected to determine the Cmax of tenofovir alafenamide.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at 24 Hours (C24) of Tenofovir Alafenamide
Blood samples will be collected to determine the C24 of tenofovir alafenamide.
Measured: At designated time points (up to approximately 24 hours post dose)
Time to Maximum Plasma Concentration (Tmax) of Tenofovir Alafenamide
Blood samples will be collected to determine the Tmax of tenofovir alafenamide.
Measured: At designated time points (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Tenofovir Alafenamide
Blood samples will be collected to determine the t½ of tenofovir alafenamide.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Tenofovir
Blood samples will be collected to determine the Cmax of tenofovir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at (C24) of Tenofovir
Blood samples will be collected to determine the C24 of tenofovir.
Measured: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Tenofovir
Blood samples will be collected to determine the Tmax of tenofovir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Tenofovir
Blood samples will be collected to determine the t½ of tenofovir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Dolutegravir
Blood samples will be collected to determine the Cmax of dolutegravir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at (C24) of Dolutegravir
Blood samples will be collected to determine the C24 of dolutegravir.
Measured: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Dolutegravir
Blood samples will be collected to determine the Tmax of dolutegravir.
Measured: At designated timepoints (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Dolutegravir
Blood samples will be collected to determine the t½ of dolutegravir.
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 posted15 Apr 2026
- Study start11 May 2026
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
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
- NCT07532304
- Sponsor's protocol ID
- 4646-006
- Other IDs
- MK-4646-006
- Status last verified
- Aug 2026
- First submitted
- 8 Apr 2026
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir
- ClinicalTrials.gov ID
- NCT07532304
- Acronym / sponsor ID
- 4646-006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 15 Apr 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.
HIV-1 treatments, called ART (antiretroviral therapy), involve taking medicines to lower the amount of HIV-1 virus in the body. Standard ART may include Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) and Dolutegravir (DTG).
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 trials in healthy people.
The goals of this study are to learn:
- If taking MK 4646 together with BIC/FTC/TAF or DTG changes the amount of these ARTs in the blood over time.
- About the safety of MK-4646 and if people tolerate it. Tolerate means participants will receive treatment 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) | Experimental | Drug: Bictegravir/emtricitabine/tenofovir alafenamideParticipants will receive a single oral dose of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). |
| Treatment B: dolutegravir (DTG) | Experimental | Drug: DolutegravirParticipants will receive a single oral dose of dolutegravir (DTG). |
| Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) | Experimental | Drug: Bictegravir/emtricitabine/tenofovir alafenamide, Drug: MK4646Participants will receive a single oral dose of MK-4646 coadministered with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). |
| Treatment D: MK-4646 + dolutegravir (DTG) | Experimental | Drug: Dolutegravir, Drug: MK4646Participants will receive a single oral dose of MK-4646 coadministered with dolutegravir (DTG). |
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 (2 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)
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 |
|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamideSingle oral tablet | Drug | Treatment A: bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) |
| DolutegravirOral tablet | Drug | Treatment B: dolutegravir (DTG), Treatment D: MK-4646 + dolutegravir (DTG) |
| MK4646Oral capsule | Drug | Treatment C: MK-4646 + bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), Treatment D: MK-4646 + dolutegravir (DTG) |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Bictegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of bictegravir.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Emtricitabine
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of emtricitabine.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir Alafenamide
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of tenofovir alafenamide.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Tenofovir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of tenofovir.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) of Dolutegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Blood samples will be collected to determine the AUC0-∞ of dolutegravir.
22 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 44 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 31 Days
Maximum Plasma Concentration (Cmax) of Bictegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at 24 Hours (C24) of Bictegravir
Time frame: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Bictegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Bictegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Emtricitabine
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at 24 Hours (C24) of Emtricitabine
Time frame: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Emtricitabine
Time frame: At designated time points (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Emtricitabine
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Tenofovir Alafenamide
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at 24 Hours (C24) of Tenofovir Alafenamide
Time frame: At designated time points (up to approximately 24 hours post dose)
Time to Maximum Plasma Concentration (Tmax) of Tenofovir Alafenamide
Time frame: At designated time points (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Tenofovir Alafenamide
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Tenofovir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at (C24) of Tenofovir
Time frame: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Tenofovir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Tenofovir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Maximum Plasma Concentration (Cmax) of Dolutegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Plasma Concentration at (C24) of Dolutegravir
Time frame: 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of Dolutegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Apparent Terminal Half-life (t½) of Dolutegravir
Time frame: At designated timepoints (up to approximately 72 hours post dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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 Bictegravir/emtricitabine/tenofovir alafenamide, Dolutegravir and MK4646 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 2 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: finished, as of the sponsor's last update on 25 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-∞) of Bictegravir (time frame: At designated timepoints (up to approximately 72 hours post dose)). The study lists 5 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 25 Aug 2026.