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Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID07661108

Study of How Food and Other Medicines Affect MK-8527 in Healthy Adults Ages 18 to 55

Led by Merck Sharp & Dohme LLC · Updated on 2026-07-02

44

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying a medicine called MK-8527 to understand how it behaves in the bodies of healthy adults aged 18 to 55. The study aims to learn how MK-8527 interacts when taken with food or combined with other medicines like probenecid and itraconazole. The goal is also to assess the safety of MK-8527 and whether participants can tolerate it without needing to stop due to health issues. Participants will receive single doses of MK-8527 under different conditions with food and without food, alone and combined with probenecid, and alone and combined with itraconazole. This crossover study allows each participant to experience all these dosing scenarios to compare how the medicine behaves in each case. During the study, participants will be monitored through blood and urine tests at specified times up to 336 hours after dosing to measure MK-8527 levels and its clearance. Researchers will also track any side effects or reasons for stopping treatment over approximately 43 days. The study is conducted by Merck Sharp & Dohme LLC and is expected to complete in October 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be in good health
  • Have a body mass index (BMI) between 18 and 32 kg/m², inclusive
  • Be between 18 and 55 years old
Not Eligible

You will not qualify if you...

  • Have an estimated glomerular filtration rate (eGFR) less than or equal to 90 mL/min/1.73 m²
  • Have a history of serious endocrine, gastrointestinal, cardiovascular, blood, liver, immune, kidney, lung, genitourinary, or major neurological conditions including stroke or chronic seizures
  • Have had stomach or intestinal surgery that could affect drug absorption or excretion (simple appendectomy and hernia repair allowed)
  • Have a history of cancer (malignancy)
  • Are taking any medication containing emtricitabine (FTC) or lamivudine (3TC)

Research Team

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