Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
Chronic Hepatitis C Infection
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Chronic hepatitis C virus infection, JNJ-47910382, Pharmacokinetics, Caucasian genotype-1, Non-structural protein 5A (NS5A) inhibitor
Eligibility Criteria
Inclusion Criteria:
- Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b
- Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection
- HCV RNA level of >100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
- Patients having good accessible veins
Exclusion Criteria:
- Evidence of liver cirrhosis or decompensated liver disease
- Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening
- Patient infected/coinfected with non-genotype-1 HCV at study screening
- Patient with any cardiac disease at screening, or any active clinically significant disease, or medical history or physical examination findings during screening
- Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Panel I
Panel II
Panel III
Panel IV
Patients will be randomized to receive JNJ-47910382 at a dose of 30 mg or placebo as monotherapy once daily for 5 days.
Patients will be randomized to receive JNJ-47910382 at a dose of 90 mg or placebo as monotherapy once daily for 5 days.
Patients will be randomized to receive JNJ-47910382 at a dose of 300 mg or placebo as monotherapy once daily for 5 days.
Patients will be randomized to receive JNJ-47910382 at a dose of 400 or 450 mg once daily or 300 mg twice daily (morning dose only on Day 5) or placebo as monotherapy for 5 days.