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

June 16, 2026 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Not yet recruiting

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: MK-8527 Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.	Drug: MK-8527 Oral tablet
Experimental: Part 2: MK-8527 + Probenecid Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.	Drug: MK-8527 Oral tablet Drug: Probenecid Oral tablet
Experimental: Part 3: MK-8527 + Itraconazole Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.	Drug: Itraconazole Oral solution Drug: MK-8527 Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.	Predose and at designated timepoints (up to 336 hours postdose)
Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid Time Frame: Predose and at designated timepoints (up to 336 hours postdose)	Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.	Predose and at designated timepoints (up to 336 hours postdose)
Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole Time Frame: Predose and at designated timepoints (up to 336 hours postdose)	Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.	Predose and at designated timepoints (up to 336 hours postdose)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Merck Clinical Trials Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 7, 2026

Primary Completion (Estimated)

October 9, 2026

Study Completion (Estimated)

October 9, 2026

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

8527-021
MK-8527-021 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Estimated)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Itraconazole

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