Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
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
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedNovember 21, 2011
November 1, 2011
2 months
November 9, 2011
November 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Study Arms (5)
Dose 1 JTK-853
EXPERIMENTALDose 2 JTK-853
EXPERIMENTALDose 3 JTK-853
EXPERIMENTALDose 4 JTK-853
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shoji Hoshino, D.V.M
Akros Pharma Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 17, 2011
Study Start
August 1, 2010
Primary Completion
October 1, 2010
Study Completion
September 1, 2011
Last Updated
November 21, 2011
Record last verified: 2011-11