Skip to main content
OpenTrials
Completed

NCT Number: NCT01473056

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Virus Infection, Response to Therapy of Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

JTK-853

Drug

Tablets, twice a day for 3 days

Dose 2 JTK-853

Drug

Tablets, twice a day for 3 days

Dose 3 JTK-853

Drug

Tablets, three times a day for 3 days

Dose 4 JTK-853

Drug

Tablets, twice a day for 3 days

Placebo

Drug

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

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: 1 week

  2. Maximum concentration (Cmax) of JTK-853 and metabolite M2

    Time frame: 1 week

  3. Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2

    Time frame: 1 week

  4. Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2

    Time frame: 1 week

  5. Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2

    Time frame: 1 week

  6. Viral load change from baseline to end of treatment

    Time frame: 48 weeks

  7. Genotypic resistance assessment and viral load change from baseline over time

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 17, 2011
Registry last updated
Nov 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.