NCT01473056

Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus Infection, Response to Therapy of

Interventions

Type	Name	Description
DRUG	JTK-853	Tablets, twice a day for 3 days
DRUG	Dose 2 JTK-853	Tablets, twice a day for 3 days
DRUG	Dose 3 JTK-853	Tablets, three times a day for 3 days
DRUG	Dose 4 JTK-853	Tablets, twice a day for 3 days
DRUG	Placebo	Tablets, twice a day or three times a day for 3 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-10-01
• Completion: 2011-09-01
• First posted: 2011-11-17
• Last updated: 2011-11-21

Locations

1 site across 1 country: Puerto Rico