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

Sponsor
Akros Pharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01473056
Collaborator
(none)
29
Enrollment
1
Location
5
Arms
13
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: JTK-853
  • Drug: Dose 2 JTK-853
  • Drug: Dose 3 JTK-853
  • Drug: Dose 4 JTK-853
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Number of subjects with adverse events [1 week]

  2. Maximum concentration (Cmax) of JTK-853 and metabolite M2 [1 week]

  3. Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2 [1 week]

  4. Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2 [1 week]

  5. Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2 [1 week]

  6. Viral load change from baseline to end of treatment [48 weeks]

  7. Genotypic resistance assessment and viral load change from baseline over time [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akros Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01473056
Other Study ID Numbers:
  • AK853-U-09-002
First Posted:
Nov 17, 2011
Last Update Posted:
Nov 21, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Akros Pharma Inc.
Hepatitis C
JTK-853
Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis

Study Results

No Results Posted as of Nov 21, 2011