HealthyPhase 1NCT06816043
A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants
A Phase 1 study testing MK-8527 and FTC/TDF in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-8527 and FTC/TDF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to 17 Jun 2025
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
- Has body mass index (BMI) ≥18 and ≤32.0 kg/m^2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of low bone density, renal impairment, Fanconi syndrome, autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis), liver disease
- History of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Phase 1 Study to Characterize the Effects of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) on the Pharmacokinetics of MK-8527 in Healthy Participants
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Treatment B).
- Conditions
- Healthy
- Being tested
- MK-8527, FTC/TDF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-8527Drug
Oral Capsule
FTC/TDFDrug
Also called emtricitabine/tenofovir disoproxil fumarate
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: MK-8527 | Experimental | Participants receive a single dose of MK-8527. Receives: Drug: MK-8527 |
| Treatment B: MK-8527 + FTC/TDF | Experimental | Participants receive FTC/TDF then MK-8527. Receives: Drug: MK-8527; Drug: FTC/TDF |
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 after single dosing (AUC0-Inf) of MK-8527-Triphosphate (TP) in peripheral blood mononuclear cell (PBMC)
Blood samples will be collected to determine the AUC0-Inf of MK-8527-TP in PBMC.
Measured: Pre-dose and at designated time points up to 840 hours post dose
Area Under the Concentration-Time Curve from Time 0 to Last quantifiable sample (AUC0-last) of MK-8527-TP in PBMC
Blood samples will be collected to determine the AUC0-last of MK-8527-TP in PBMC.
Measured: Pre-dose and at designated time points up to 840 hours post dose
Drug Concentration at 672 Hours (C672) of MK-8527-TP in PBMC
Blood samples will be collected to determine the C672 of MK-8527-TP in PBMC.
Measured: Pre-dose and at designated time points up to 672 hours post dose
Maximum Plasma Concentration (Cmax) of MK-8527-TP in PBMC
Blood samples will be collected to determine the Cmax of MK-8527-TP in PBMC.
Measured: Pre-dose and at designated time points up to 840 hours post dose
Time to Maximum Plasma Concentration (Tmax) of MK-8527-TP in PBMC
Blood samples will be collected to determine the Tmax of MK-8527-TP in PBMC.
Measured: Pre-dose and at designated time points up to 840 hours post dose
Apparent Terminal Half-life (t1/2) of MK-8527-TP in PBMC
Blood samples will be collected to determine the t1/2 of MK-8527-TP in PBMC.
Measured: Pre-dose and at designated time points up to 840 hours post dose
Secondary outcomes (9)
AUC0-Inf of MK-8527 in plasma
Blood samples will be collected to determine the AUC0-Inf of MK-8527 in plasma.
Measured: Pre-dose and at designated time points up to 120 hours post dose
AUC0-last of MK-8527 in plasma
Blood samples will be collected to determine the AUC0-last of MK-8527 in plasma.
Measured: Pre-dose and at designated time points up to 120 hours post dose
Cmax of of MK-8527 in plasma
Blood samples will be collected to determine the Cmax of MK-8527 in plasma.
Measured: Pre-dose and at designated time points up to 120 hours post dose
Tmax of MK-8527 in plasma
Blood samples will be collected to determine the Tmax of MK-8527 in plasma.
Measured: Pre-dose and at designated time points up to 120 hours post dose
t1/2 of MK-8527 in plasma
Blood samples will be collected to determine the t1/2 of MK-8527 in plasma.
Measured: Pre-dose and at designated time points up to 120 hours post dose
Apparent Clearance (CL/F) of MK-8527 in plasma
Blood samples will be collected to determine the CL/F MK-8527 in plasma
Measured: Pre-dose and at designated time points up to 120 hours post dose
Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma
Blood samples will be collected to determine the Vz/F of MK-8527 in plasma
Measured: Pre-dose and at designated time points up to 120 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 111 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start21 Feb 2025
- Primary completion5 Jun 2025
- Study completion17 Jun 2025
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
- 20 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
- NCT06816043
- Sponsor's protocol ID
- 8527-016
- Other IDs
- MK-8527-016
- Status last verified
- Jun 2025
- First submitted
- 4 Feb 2025
- Last updated
- 27 Jun 2025
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Study to Characterize the Effects of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) on the Pharmacokinetics of MK-8527 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06816043
- Acronym / sponsor ID
- 8527-016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 10 Feb 2025 (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.
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Treatment B).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: MK-8527 | Experimental | Drug: MK-8527Participants receive a single dose of MK-8527. |
| Treatment B: MK-8527 + FTC/TDF | Experimental | Drug: MK-8527, Drug: FTC/TDFParticipants receive FTC/TDF then MK-8527. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
- Has body mass index (BMI) ≥18 and ≤32.0 kg/m^2
Key exclusion criteria (4 listed)
- History of low bone density, renal impairment, Fanconi syndrome, autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis), liver disease
- History of cancer (malignancy)
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
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 |
|---|---|---|
| MK-8527Oral Capsule | Drug | Treatment A: MK-8527, Treatment B: MK-8527 + FTC/TDF |
| FTC/TDFAlso: emtricitabine/tenofovir disoproxil fumarateOral Tablet | Drug | Treatment B: MK-8527 + FTC/TDF |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity after single dosing (AUC0-Inf) of MK-8527-Triphosphate (TP) in peripheral blood mononuclear cell (PBMC)
Time frame: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the AUC0-Inf of MK-8527-TP in PBMC.
Area Under the Concentration-Time Curve from Time 0 to Last quantifiable sample (AUC0-last) of MK-8527-TP in PBMC
Time frame: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the AUC0-last of MK-8527-TP in PBMC.
Drug Concentration at 672 Hours (C672) of MK-8527-TP in PBMC
Time frame: Pre-dose and at designated time points up to 672 hours post dose
Blood samples will be collected to determine the C672 of MK-8527-TP in PBMC.
Maximum Plasma Concentration (Cmax) of MK-8527-TP in PBMC
Time frame: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the Cmax of MK-8527-TP in PBMC.
Time to Maximum Plasma Concentration (Tmax) of MK-8527-TP in PBMC
Time frame: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the Tmax of MK-8527-TP in PBMC.
Apparent Terminal Half-life (t1/2) of MK-8527-TP in PBMC
Time frame: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the t1/2 of MK-8527-TP in PBMC.
9 secondary outcomes
AUC0-Inf of MK-8527 in plasma
Time frame: Pre-dose and at designated time points up to 120 hours post dose
AUC0-last of MK-8527 in plasma
Time frame: Pre-dose and at designated time points up to 120 hours post dose
Cmax of of MK-8527 in plasma
Time frame: Pre-dose and at designated time points up to 120 hours post dose
Tmax of MK-8527 in plasma
Time frame: Pre-dose and at designated time points up to 120 hours post dose
t1/2 of MK-8527 in plasma
Time frame: Pre-dose and at designated time points up to 120 hours post dose
Apparent Clearance (CL/F) of MK-8527 in plasma
Time frame: Pre-dose and at designated time points up to 120 hours post dose
Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma
Time frame: Pre-dose and at designated time points up to 120 hours post dose
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 111 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 43 days
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 27 Jun 2025.
- 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 MK-8527 and FTC/TDF 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 3 inclusion and 4 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 27 Jun 2025. 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 after single dosing (AUC0-Inf) of MK-8527-Triphosphate (TP) in peripheral blood mononuclear cell (PBMC) (time frame: Pre-dose and at designated time points up to 840 hours post dose). The study lists 6 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 27 Jun 2025.