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

Phase 1

Completed

• Conditions: Hepatitis C Virus Infection, Response to Therapy of
• Interventions: Drug: JTK-853; Drug: Dose 2 JTK-853; Drug: Dose 3 JTK-853; Drug: Dose 4 JTK-853; Drug: Placebo

• Registration Number: NCT01473056
• Lead Sponsor: Akros Pharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2010-10
• Study Completion: 2011-09
• Status Verified: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Last Update Submitted: 2011-11-17
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 JTK-853	JTK-853	-
Dose 2 JTK-853	Dose 2 JTK-853	-
Dose 3 JTK-853	Dose 3 JTK-853	-
Dose 4 JTK-853	Dose 4 JTK-853	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M2	1 week
Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2	1 week
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2	1 week
Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2	1 week
Viral load change from baseline to end of treatment	48 weeks
Genotypic resistance assessment and viral load change from baseline over time	48 weeks

Trial Locations

Locations (1)

Fundacion de Investigacion de Diego; 🇵🇷 San Juan, Puerto Rico