Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382

NCT ID: NCT01651767

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-06-30

Brief Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (what the body does to the medication) and antiviral activity of JNJ-47910382 when administered in different dosing regimens in Caucasian genotype-1 chronic HCV-infected patients.

Detailed Description

This is a Phase Ib, double-blind (neither physician nor patient knows the treatment that the patient receives), randomized (the study drug is assigned by chance), placebo-controlled study in treatment-naïve (someone who has never used drugs for HCV infection), Caucasian genotype 1 chronic HCV-infected patients. The study consists of a screening period, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. The patients will be divided over 4 panels of 10 patients each that will be initiated sequentially. In each panel patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382 or placebo will be administered once daily or twice daily. Within each panel, 5 patients of genotype-1a and 5 patients of genotype-1b will be enrolled. Patients will be randomly assigned to receive active treatment or placebo in such a way that 4 patients of each genotype receive active treatment and 1 subject of each genotype receives placebo. The pharmacokinetic profile of JNJ-47910382 will be assessed in each panel. HCV RNA kinetics (HCV RNA level) and HCV resistance will be studied and biomarkers at the messenger RNA (mRNA), protein and cell level will be explored. The entire study duration for each participant will be approximately four weeks.

Conditions

Chronic Hepatitis C Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Panel I

Patients will be randomized to receive JNJ-47910382 at a dose of 30 mg or placebo as monotherapy once daily for 5 days.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Form=suspension, route=oral.

JNJ-47910382

Intervention Type: DRUG

Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral. Study drug will be administered once or twice daily

Panel II

Patients will be randomized to receive JNJ-47910382 at a dose of 90 mg or placebo as monotherapy once daily for 5 days.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Form=suspension, route=oral.

JNJ-47910382

Intervention Type: DRUG

Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral. Study drug will be administered once or twice daily

Panel III

Patients will be randomized to receive JNJ-47910382 at a dose of 300 mg or placebo as monotherapy once daily for 5 days.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Form=suspension, route=oral.

JNJ-47910382

Intervention Type: DRUG

Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral. Study drug will be administered once or twice daily

Panel IV

Patients will be randomized to receive JNJ-47910382 at a dose of 400 or 450 mg once daily or 300 mg twice daily (morning dose only on Day 5) or placebo as monotherapy for 5 days.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Form=suspension, route=oral.

JNJ-47910382

Intervention Type: DRUG

Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral. Study drug will be administered once or twice daily

Interventions

Placebo

Form=suspension, route=oral.

Intervention Type: DRUG

JNJ-47910382

Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral. Study drug will be administered once or twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chronic (diagnosis of hepatitis C more than or 6 months before the screening period) HCV infection. Geno- and subtype should be determined or confirmed at screening, and should be 1a or 1b
• Never received (Peg) IFN, RBV or any other approved or investigational antiviral treatment for chronic HCV infection
• HCV RNA level of >100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
• Patients having good accessible veins

Exclusion Criteria

• Evidence of liver cirrhosis or decompensated liver disease
• Patient coinfected with HIV-1 or HIV-2, or hepatitis A or B virus infection, or active tuberculosis at study screening
• Patient infected/coinfected with non-genotype-1 HCV at study screening
• Patient with any cardiac disease at screening, or any active clinically significant disease, or medical history or physical examination findings during screening
• Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, thyroid disease or disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen R&D Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen R&D Ireland Clinical Trial

Role: STUDY_DIRECTOR

Janssen R&D Ireland

Locations

Hamburg, , Germany

Kiel, , Germany

Mainz, , Germany

Münster, , Germany

Tübingen, , Germany

Ulm, , Germany

Countries

Germany

Other Identifiers

47910382HPC1002

Identifier Type: OTHER

Identifier Source: secondary_id

2011-005110-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100760

Identifier Type: -

Identifier Source: org_study_id