A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS AND ANTIVIRAL ACTIVITY OF JTK-652 ADMINISTERED FOR FOUR WEEKS IN SUBJECTS WITH CHRONIC HEPATITIS C INFECTIO
- Conditions
- 10047438hepatitis c
- Registration Number
- NL-OMON31911
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Age : 18-65 yr, inclusive
BMI : 18.5-32 kg/m2, inclusive
Subjects : males and postmenopausal females with
- chronic hepatitis C infection (genotype 1a or 1b, or mixed 1a/1b)
- HCV-RNA * 100 KIU/mL
- ALAT * 5 times of upper limit of normal (ULN
1. Evidence of human immunodeficiency virus (HIV) infection (enzyme immunoassay confirmed by Western blot)
2. Evidence of chronic hepatitis B virus (HBV) infection (HB surface antigen [HBsAg])
3. Evidence of acute hepatitis A infection (hepatitis A IgM+)
4. Antiviral therapy for HCV within preceding 6 months (including all types of interferon, ie, standard, pegylated)
5. Systemic antiviral, cytotoxic, hepatotoxic, or immunomodulatory therapy within 3 months prior to first dose
6. Recent (* 3 months prior to screening) history of alcohol or drug abuse
7. Evidence of Child-Pugh B or C liver disease (for Child-Pugh classification see Appendix 9.7)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety : AEs, clinical laboratory parameters, vital signs, ECG and physical<br /><br>examination<br /><br>Pharmacokinetics : plasma JTK-652 concentrations, pharmacokinetic parameters<br /><br>(Cmax, Ctrough, tmax, AUC0-*, Rac</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy : HCV RNA reduction (log10 copies/mL) from baseline at Week 4 and<br /><br>percent change and change from baseline in ALAT reduction (IU/L) at Week 4</p><br>