A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: 200 mg MK-1075; 400 mg MK-1075; 800 mg MK-1075
Intervention description: Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days; Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days; Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to
      suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose
      administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and
      well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction
      is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration
      of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female of non-childbearing potential

          -  Have a body mass index (BMI) >=18 to =< 37 kg/m^2

          -  Excepting HCV infection, be in good health

          -  Have a clinical diagnosis of chronic HCV infection, exclusively GT1 or exclusively GT3

          -  Agree to follow smoking restrictions

        Exclusion Criteria:

          -  Has a history of clinically significant, not stably controlled endocrine,
             gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal,
             respiratory, genitourinary, or major neurological abnormalities or diseases.

          -  Have been treated with amiodarone within the prior year, or is currently on
             beta-blockers or verapamil

          -  Has a history of cancer (malignancy)

          -  Has a history of significant multiple and/or severe allergies (e.g., food, drug, latex
             allergy), or has had an anaphylactic reaction or significant intolerability to
             prescription or non-prescription drugs or food

          -  Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV)

          -  Has had major surgery, donated or lost approximately 500 mL blood within 4 weeks prior
             to screening visit

          -  Has participated in another drug trial within 4 weeks prior to screening visit

          -  Is taking a non-permitted medication to treat a co-morbid condition

          -  Consumes greater than 2 glasses of alcoholic beverages

          -  Is a regular user of cannabis, any illicit drugs or has a history of drug (including
             alcohol) abuse within approximately 12 months

          -  Has evidence or history of chronic hepatitis not caused by HCV, including but not
             limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced
             hepatitis, or autoimmune hepatitis

          -  Has been treated with other HCV inhibitors, such as sofosbuvir or VX-135

          -  Has evidence of advanced or decompensated liver disease, bridging fibrosis or higher
             grade fibrosis from a prior liver biopsy