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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01473056
Enrollment
29
Registered
2011-11-17
Start date
2010-08-31
Completion date
2011-09-30
Last updated
2011-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus Infection, Response to Therapy of

Keywords

Hepatitis C, JTK-853

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.

Interventions

DRUGJTK-853

Tablets, twice a day for 3 days

DRUGDose 2 JTK-853

Tablets, twice a day for 3 days

DRUGDose 3 JTK-853

Tablets, three times a day for 3 days

DRUGDose 4 JTK-853

Tablets, twice a day for 3 days

DRUGPlacebo

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

Sponsors

Akros Pharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of subjects with adverse events1 week
Maximum concentration (Cmax) of JTK-853 and metabolite M21 week
Time to reach maximum concentration (tmax) for JTK-853 and metabolite M21 week
Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M21 week
Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M21 week
Viral load change from baseline to end of treatment48 weeks
Genotypic resistance assessment and viral load change from baseline over time48 weeks

Countries

Puerto Rico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026