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

Tracking Information

First Received Date ^ICMJE

November 9, 2011

Last Updated Date

November 17, 2011

Start Date ^ICMJE

August 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473056 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatitis C Virus Infection, Response to Therapy of

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Dose 1 JTK-853
Intervention: Drug: JTK-853
Experimental: Dose 2 JTK-853
Intervention: Drug: Dose 2 JTK-853
Experimental: Dose 3 JTK-853
Intervention: Drug: Dose 3 JTK-853
Experimental: Dose 4 JTK-853
Intervention: Drug: Dose 4 JTK-853
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Puerto Rico

Administrative Information

NCT Number ^ICMJE

NCT01473056

Other Study ID Numbers ^ICMJE

AK853-U-09-002

Has Data Monitoring Committee

Responsible Party

Akros Pharma Inc.

Study Sponsor ^ICMJE

Akros Pharma Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Shoji Hoshino, D.V.M

Akros Pharma Inc.

Information Provided By

Akros Pharma Inc.

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top