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

Akros Pharma

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus Infection, Response to Therapy of

Treatments: Drug: Dose 3 JTK-853; Drug: Dose 4 JTK-853; Drug: Dose 2 JTK-853; Drug: JTK-853; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473056

AK853-U-09-002

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

29 participants in 5 patient groups, including a placebo group

Dose 1 JTK-853

Experimental group

Treatment:

Drug: JTK-853

Dose 2 JTK-853

Experimental group

Treatment:

Drug: Dose 2 JTK-853

Dose 3 JTK-853

Experimental group

Treatment:

Drug: Dose 3 JTK-853

Dose 4 JTK-853

Experimental group

Treatment:

Drug: Dose 4 JTK-853

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo