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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatitis C Virus Infection, Response to Therapy of

Intervention / Treatment
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* Drug: JTK-853
* Drug: Dose 2 JTK-853
* Drug: Dose 3 JTK-853
* Drug: Dose 4 JTK-853
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 JTK-853<br> | Drug: JTK-853<br>* Tablets, twice a day for 3 days<br>|
| Experimental: Dose 2 JTK-853<br> | Drug: Dose 2 JTK-853<br>* Tablets, twice a day for 3 days<br>|
| Experimental: Dose 3 JTK-853<br> | Drug: Dose 3 JTK-853<br>* Tablets, three times a day for 3 days<br>|
| Experimental: Dose 4 JTK-853<br> | Drug: Dose 4 JTK-853<br>* Tablets, twice a day for 3 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Tablets, twice a day or three times a day for 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 1 week | 
| Maximum concentration (Cmax) of JTK-853 and metabolite M2 |  | 1 week | 
| Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2 |  | 1 week | 
| Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2 |  | 1 week | 
| Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2 |  | 1 week | 
| Viral load change from baseline to end of treatment |  | 48 weeks | 
| Genotypic resistance assessment and viral load change from baseline over time |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, JTK-853