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

NCT ID: NCT01473056

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Hepatitis C Virus Infection, Response to Therapy of

Keywords

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Hepatitis C JTK-853

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1 JTK-853

Group Type EXPERIMENTAL

JTK-853

Intervention Type DRUG

Tablets, twice a day for 3 days

Dose 2 JTK-853

Group Type EXPERIMENTAL

Dose 2 JTK-853

Intervention Type DRUG

Tablets, twice a day for 3 days

Dose 3 JTK-853

Group Type EXPERIMENTAL

Dose 3 JTK-853

Intervention Type DRUG

Tablets, three times a day for 3 days

Dose 4 JTK-853

Group Type EXPERIMENTAL

Dose 4 JTK-853

Intervention Type DRUG

Tablets, twice a day for 3 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets, twice a day or three times a day for 3 days

Interventions

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JTK-853

Tablets, twice a day for 3 days

Intervention Type DRUG

Dose 2 JTK-853

Tablets, twice a day for 3 days

Intervention Type DRUG

Dose 3 JTK-853

Tablets, three times a day for 3 days

Intervention Type DRUG

Dose 4 JTK-853

Tablets, twice a day for 3 days

Intervention Type DRUG

Placebo

Tablets, twice a day or three times a day for 3 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akros Pharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shoji Hoshino, D.V.M

Role: STUDY_DIRECTOR

Akros Pharma Inc.

Locations

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Fundacion de Investigacion de Diego

San Juan, , Puerto Rico

Site Status

Countries

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Puerto Rico

Other Identifiers

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AK853-U-09-002

Identifier Type: -

Identifier Source: org_study_id