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 INFECTION

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 INFECTION - JTK-652 proof of concept study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31911

Enrollment

Registered

2007-09-24

Start date

2008-01-20

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis c

Interventions

JTK-652

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
Safety : AEs, clinical laboratory parameters, vital signs, ECG and physical examination Pharmacokinetics : plasma JTK-652 concentrations, pharmacokinetic parameters (Cmax, Ctrough, tmax, AUC0-*, Rac	—

Secondary

Measure	Time frame
Efficacy : HCV RNA reduction (log10 copies/mL) from baseline at Week 4 and percent change and change from baseline in ALAT reduction (IU/L) at Week 4	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)