Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MK-8876
Intervention description: MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This adaptive design study will evaluate the safety, pharmacokinetics, and effect on
      hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV
      infection. The study will consist of 4 parts evaluating participants infected with specific
      hepatitis C virus genotypes and up to 10 panels allowing for additional participants to
      enroll in each panel as specified in the study analysis. The hypothesis evaluated in the
      study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple
      dose administration of MK-8876 in participants with HCV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  is male, or female of non-childbearing potential (non-childbearing potential is
             defined as postmenopausal without menses for ≥1 year or after medically documented
             hysterectomy, oophorectomy, or tubal ligation)

          -  agrees to use a medically acceptable method of contraception through 90 days after the
             last dose of study drug if participant has a female partner of childbearing potential
             must (males should use a condom and their partner of childbearing potential must use
             hormonal contraception, intrauterine device, diaphragm, cervical cap, or female
             condom)

          -  has a body mass index (BMI) between 18 and 37 kg/m^2

          -  has a clinical diagnosis of chronic HCV infection defined by positive serology for HCV
             for ≥6 months

          -  agrees to follow the smoking and other trial restrictions

        Exclusion Criteria:

          -  is mentally or legally institutionalized or incapacitated, has significant emotional
             problems at study start or has clinically significant psychiatric disorder of the last
             5 years

          -  has a history of clinically significant endocrine, gastrointestinal (except HCV
             infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory,
             or genitourinary abnormalities or diseases

          -  has a history of stroke, chronic seizures, or major neurological disorder

          -  has a history of cancer (except adequately treated non-melanomatous skin carcinoma,
             carcinoma in situ of the cervix, or other malignancies which have been successfully
             treated for ≥10 years

          -  has a history of significant multiple and/or severe allergies or has had an
             anaphylactic reaction or significant intolerability to drugs or food

          -  has a history of clinically significant hepatic disease, Gilbert's disease, biliary
             tract disease, or human immunodeficiency virus

          -  has had major surgery or donated or lost >1 unit of blood within 4 weeks before the
             study

          -  has participated in another investigational trial within 4 weeks before the study

          -  Is unable to refrain from or anticipates the use of any medication from 2 weeks before
             the study and throughout the study

          -  consumes >2 glasses of alcoholic beverages per day

          -  consumes >6 servings (1 serving is ~120 mg caffeine) of coffee, tea, cola, energy
             drinks, or other caffeinated beverages per day

          -  is a regular user of any illicit drugs or history of drug abuse within 12 months of
             the study

          -  has evidence or history of chronic hepatitis not caused by HCV (except acute
             non-HCV-related hepatitis that resolved >6 months before the study)

          -  has previously received treatment with another HCV non-nucleoside inhibitor (previous
             use of other HCV investigational therapies or marketed compounds is permitted if
             treatment ended ≥3 months before the study)

          -  has clinical or laboratory evidence of advanced or decompensated liver disease