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

NCT01473056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2011-11-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Akros Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Shoji Hoshino, D.V.M · Akros Pharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-10-31
Completion
2011-09-30

Countries

  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01473056 on ClinicalTrials.gov