Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-3281 in Healthy and Hepatitis C Infected Male Participants (MK-3281-002)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MK-3281; Placebo to MK-3281
Intervention description: MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose. The PM dose of MK-3281 was not administered on Day 7 (for HCV-infected males) or Day 10 (for healthy males); Dose-matched placebo to MK-3281 capsule administered orally BID for 7 or 10 consecutive days depending on randomized dose of MK-3281 in serial panel. The PM dose of matched placebo was not administered on Day 7 or 10 (depending upon allocation).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will examine the safety, tolerability and plasma pharmacokinetics of multiple
      doses of MK-3281 in healthy male participants in Part I, and in Hepatitis C Virus
      (HCV)-infected male participants in Part II. The clinical efficacy of MK-3281, as measured by
      viral load reduction, will also be assessed in Part II. The primary hypothesis is that twice
      daily administration of MK-3281 for 10 days in healthy adult male participants and for 7 days
      in HCV-infected male participants is sufficiently safe and well tolerated, based on
      assessment of clinical and laboratory adverse experiences, to permit continued clinical
      investigation.

      The results of this study will guide dose selection for future studies in both healthy
      participants and HCV-infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is judged to be in good/stable health based on medical history, physical
             examination, vital signs, and laboratory safety tests performed at the prestudy
             (screening) visit and/or prior to administration of the initial dose of study drug

          -  Participant has no clinically significant abnormality on electrocardiogram (ECG)
             performed at the prestudy (screening) visit and/or prior to administration of the
             initial dose of study drug

          -  Participants with female partner(s) of childbearing potential must agree to use a
             medically acceptable method of contraception during the study and for 90 days after
             the last dose of study drug

          -  Participant has a clinical diagnosis of chronic HCV infection (for Part II only).

        Exclusion Criteria:

          -  Participant has a history of stroke, chronic seizures, or major neurological disorder

          -  Participant has a history of clinically significant endocrine, gastrointestinal,
             cardiovascular, hematological, immunological, renal, respiratory, or genitourinary
             abnormalities or diseases

          -  Participant has a history of neoplastic disease (including leukemia, lymphoma,
             malignant melanoma), or myeloproliferative disease, regardless of the time since
             treatment

          -  Participant has positive Hepatitis B surface antigen (or other evidence of active
             Hepatitis B infection) at the prescreening (study) visit

          -  For Healthy Panel (Part I), participant has evidence of chronic Hepatitis C virus
             infection at the prescreening (study) visit

          -  Participant has a history of documented Human Immunodeficiency Virus (HIV) infection