Phase I,Randomized,Double-blind,Placebo-controlled,Multiple Dose Study Evaluating Safety,Tolerability,Pharmacokinetics and Antiviral Activity of JTK-853 in HCV Genotype 1 Infected Subjects,Followed by a Genotypic Resistance Monitoring Study

Akros Pharma Inc.1 site in 1 country29 target enrollmentAugust 2010

ConditionsHepatitis C Virus Infection, Response to Therapy of

InterventionsJTK-853 Dose 2 JTK-853 Dose 3 JTK-853 Dose 4 JTK-853 Placebo

DrugsJTK-853 Dose 2 JTK-853 Dose 3 JTK-853 Dose 4 JTK-853 Placebo

Overview

Phase: Phase 1
Intervention: JTK-853
Conditions: Hepatitis C Virus Infection, Response to Therapy of
Sponsor: Akros Pharma Inc.
Enrollment: 29
Locations: 1
Primary Endpoint: Number of subjects with adverse events
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

September 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akros Pharma Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b
•Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL
•Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)

Exclusion Criteria

•Subjects should not have previously received a direct acting anti-HCV agent
•Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks