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

Primary Purpose

Hepatitis C Virus Infection, Response to Therapy of

Status

Completed

Phase

Phase 1

Locations

Puerto Rico

Study Type

Interventional

Intervention

JTK-853

Dose 2 JTK-853

Dose 3 JTK-853

Dose 4 JTK-853

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C Virus Infection, Response to Therapy of focused on measuring Hepatitis C, JTK-853

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Dose 1 JTK-853

Dose 2 JTK-853

Dose 3 JTK-853

Dose 4 JTK-853

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects with adverse events

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

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

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

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

Viral load change from baseline to end of treatment

Genotypic resistance assessment and viral load change from baseline over time

Secondary Outcome Measures

Full Information

NCT ID

NCT01473056

First Posted

November 9, 2011

Last Updated

November 17, 2011

Sponsor

Akros Pharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01473056

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akros Pharma Inc.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus Infection, Response to Therapy of

Keywords

Hepatitis C, JTK-853

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1 JTK-853

Arm Type

Experimental

Arm Title

Dose 2 JTK-853

Arm Type

Experimental

Arm Title

Dose 3 JTK-853

Arm Type

Experimental

Arm Title

Dose 4 JTK-853

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

JTK-853

Intervention Description

Tablets, twice a day for 3 days

Intervention Type

Drug

Intervention Name(s)

Dose 2 JTK-853

Intervention Description

Tablets, twice a day for 3 days

Intervention Type

Drug

Intervention Name(s)

Dose 3 JTK-853

Intervention Description

Tablets, three times a day for 3 days

Intervention Type

Drug

Intervention Name(s)

Dose 4 JTK-853

Intervention Description

Tablets, twice a day for 3 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of subjects with adverse events

Time Frame

1 week

Title

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

Time Frame

1 week

Title

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

Time Frame

1 week

Title

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

Time Frame

1 week

Title

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

Time Frame

1 week

Title

Viral load change from baseline to end of treatment

Time Frame

48 weeks

Title

Genotypic resistance assessment and viral load change from baseline over time

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shoji Hoshino, D.V.M

Organizational Affiliation

Akros Pharma Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Fundacion de Investigacion de Diego

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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