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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01473056
First received: November 9, 2011
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C Virus Infection, Response to Therapy of
 Drug: JTK-853
Drug: Dose 2 JTK-853
Drug: Dose 3 JTK-853
Drug: Dose 4 JTK-853
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:
  • Number of subjects with adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) of JTK-853 and metabolite M2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Viral load change from baseline to end of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Genotypic resistance assessment and viral load change from baseline over time [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 JTK-853 Drug: JTK-853
Tablets, twice 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
Placebo Comparator: Placebo Drug: Placebo
Tablets, twice a day or three times a day for 3 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473056

Locations
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Akros Pharma Inc.
Investigators
Study Director: Shoji Hoshino, D.V.M Akros Pharma Inc.
  More Information

No publications provided

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT01473056     History of Changes
Other Study ID Numbers: AK853-U-09-002
Study First Received: November 9, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Akros Pharma Inc.:
Hepatitis C
JTK-853

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013