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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.