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

November 17, 2011 updated by: Akros Pharma Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Tablets, twice a day or three times a day for 3 days
Experimental: Dose 2 JTK-853
Drug: Dose 2 JTK-853
Tablets, twice a day for 3 days
Experimental: Dose 3 JTK-853
Drug: Dose 3 JTK-853
Tablets, three times a day for 3 days
Experimental: Dose 4 JTK-853
Drug: Dose 4 JTK-853
Tablets, twice a day for 3 days
Experimental: Dose 1 JTK-853
Drug: JTK-853
Tablets, twice a day for 3 days

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akros Pharma Inc.

Investigators

  • Study Director: Shoji Hoshino, D.V.M, Akros Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 17, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK853-U-09-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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