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HealthyPhase 1NCT07661108

A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)

A Phase 1 study testing MK-8527, Probenecid and Itraconazole in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults. The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
MK-8527, Probenecid and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
30 Jun 2026to 9 Oct 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Be in good health
  • Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive

Who cannot join

  • Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
  • 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 stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
  • Has a history of cancer (malignancy)
  • Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fortrea Clinical Research Unit Inc ( Site 0001)

    Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants

Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.

The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 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
MK-8527, Probenecid, Itraconazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-8527Drug

    Oral tablet

  • ProbenecidDrug

    Oral tablet

  • ItraconazoleDrug

    Oral solution

Study groups in NCT07661108
Study groupRoleWhat they receive
Part 1: MK-8527ExperimentalParticipants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
Receives: Drug: MK-8527
Part 2: MK-8527 + ProbenecidExperimentalParticipants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
Receives: Drug: MK-8527; Drug: Probenecid
Part 3: MK-8527 + ItraconazoleExperimentalParticipants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
Receives: Drug: MK-8527; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food

    Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  2. Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid

    Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  3. Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole

    Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

Secondary outcomes (22)

  1. Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food

    Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  2. Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food

    Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  3. Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food

    Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  4. Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food

    Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  5. Part 1: 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 AE will be reported.

    Measured: Up to approximately 43 days

  6. Part 1: 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 43 days

  7. Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid

    Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  8. Part 2: Tmax of MK-8527 in Plasma with and without Probenecid

    Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  9. Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid

    Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  10. Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid

    Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  11. Part 2: Urine Concentration at 72 Hours of MK-8527

    Urine samples will be collected to estimate the urine concentration of MK-8527.

    Measured: At designated timepoints (up to 72 hours postdose)

  12. Part 2: Renal Clearance of MK-8527

    Urine samples will be collected to estimate the renal clearance of MK-8527.

    Measured: At designated timepoints (up to 72 hours postdose)

  13. Part 2: Number of Participants Who Experience 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 experience AE will be reported.

    Measured: Up to approximately 43 days

  14. Part 2: 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 43 days

  15. Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole

    Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  16. Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole

    Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  17. Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole

    Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  18. Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole

    Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.

    Measured: Predose and at designated timepoints (up to 336 hours postdose)

  19. Part 3: Urine Concentration at 72 Hours of MK-8527

    Urine samples will be collected to estimate the urine concentration of MK-8527.

    Measured: At designated timepoints (up to 72 hours postdose)

  20. Part 3: Renal Clearance of MK-8527

    Urine samples will be collected to estimate the renal clearance of MK-8527.

    Measured: At designated timepoints (up to 72 hours postdose)

  21. Part 3: Number of Participants Who Experience 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 experience AE will be reported.

    Measured: Up to approximately 43 days

  22. Part 3: 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 43 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start30 Jun 2026
  3. Primary completion9 Oct 2026 (estimated)
  4. Study completion9 Oct 2026 (estimated)

Resources

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07661108
Sponsor's protocol ID
8527-021
Other IDs
MK-8527-021
Status last verified
Sep 2026
First submitted
16 Jun 2026
Last updated
3 Sep 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-8527, Probenecid and Itraconazole 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 5 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 3 Sep 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?

Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food (time frame: Predose and at designated timepoints (up to 336 hours postdose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07661108.

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 3 Sep 2026.

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