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

Purpose

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.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: MK-8527
    Oral tablet
  • Drug: Itraconazole
    Oral solution

Recruiting Locations

Fortrea Clinical Research Unit Inc ( Site 0001)
Daytona Beach, Florida 32117
Contact:
Study Coordinator
386-366-6400

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com