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

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ClinicalTrials.gov Identifier: NCT01473056
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : November 21, 2011
Sponsor:
Information provided by (Responsible Party):
Akros Pharma Inc.

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
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  (Clinical Trial)
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 : August 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Akros Pharma Inc.
ClinicalTrials.gov Identifier: NCT01473056     History of Changes
Other Study ID Numbers: AK853-U-09-002
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: November 2011

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