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

NCT07661108 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 8527-021MK-8527-021
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (22)

• 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

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

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

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

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

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

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

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

• Part 1: Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 43 days

Study Arms (3)

Part 1: MK-8527

EXPERIMENTAL

Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.

Drug: MK-8527

Part 2: MK-8527 + Probenecid

EXPERIMENTAL

Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.

Drug: MK-8527; Drug: Probenecid

Part 3: MK-8527 + Itraconazole

EXPERIMENTAL

Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.

Drug: MK-8527; Drug: Itraconazole

Interventions

MK-8527 DRUG

Oral tablet

Part 1: MK-8527; Part 2: MK-8527 + Probenecid; Part 3: MK-8527 + Itraconazole

Probenecid DRUG

Oral tablet

Part 2: MK-8527 + Probenecid

Itraconazole DRUG

Oral solution

Part 3: MK-8527 + Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc ( Site 0001)

Daytona Beach, Florida, 32117, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Probenecid; Itraconazole

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): October 9, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)