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

Hepatitis C Virus Infection, Response to Therapy of Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473056
• Other study ID #: AK853-U-09-002
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2011
• Last updated: November 17, 2011
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection, Response to Therapy of
• Virus Diseases

Intervention

Drug:
• JTK-853
Tablets, twice a day for 3 days
• Dose 2 JTK-853
Tablets, twice a day for 3 days
• Dose 3 JTK-853
Tablets, three times a day for 3 days
• Dose 4 JTK-853
Tablets, twice a day for 3 days
• Placebo
Tablets, twice a day or three times a day for 3 days

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		1 week	Yes
Primary	Maximum concentration (Cmax) of JTK-853 and metabolite M2		1 week	No
Primary	Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2		1 week	No
Primary	Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2		1 week	No
Primary	Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2		1 week	No
Primary	Viral load change from baseline to end of treatment		48 weeks	No
Primary	Genotypic resistance assessment and viral load change from baseline over time		48 weeks	No