A Study of the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of JNJ-47910382 at Different Doses and Dose Regimens in Asian Genotype-1, Chronic, HCV-Infected Patients

NCT ID: NCT01586325

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-25
• Study Completion Date: 2014-04-21

Brief Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (how a drug is absorbed and distributed in the body), and intrinsic antiviral activity of JNJ-47910382 after 5 consecutive days of administration in chronic, hepatitis C virus (HCV)-genotype-1-infected patients at different doses and dose regimens.

Detailed Description

This is a double-blind (neither physician nor patient knows the name of the assigned drug), randomized (patients are assigned by chance to treatment groups) placebo-controlled study. A placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The study population will consist of Asian treatment-naive genotype-1, chronic HCV-infected patients. The trial will involve a screening period at a maximum of 6 weeks before baseline, a 9-day treatment period (with 5 days of actual medication intake) and a 4-week follow-up period. Patients will be divided into 3 panels of 8 patients (Panel 1) or 5 patients (Panels 2 and 3). Treatment will be initiated in each panel of patients sequentially. In each panel, patients will receive JNJ-47910382 or placebo during 5 consecutive days. JNJ-47910382, or placebo, will be administered once daily. Treatments will be taken by mouth and with standardized meals in all dosing regimens. Patient safety will be monitored.

Conditions

Chronic Hepatitis C Infection

Study Design

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

Study Groups

Panel 1

Study participants will receive double-blind treatment with JNJ-47910382 30 mg or matching placebo. Participants in each of Panel will be treated sequentially (ie, participants in Panel 1 will be treated before participants in Panel 2, participants in Panel 2 will be treated before participants in Panel 3).

Group Type: EXPERIMENTAL

JNJ-47910382 30 mg

Intervention Type: DRUG

JNJ-47910382 30 mg (0.6 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

Placebo

Intervention Type: DRUG

Matching Placebo administered once daily as monotherapy for 5 days.

Panel 2

Study participants will receive double-blind treatment with JNJ-47910382 90 mg or matching placebo. Participants in each of Panel will be treated sequentially.

Group Type: EXPERIMENTAL

JNJ-47910382 90 mg

Intervention Type: DRUG

JNJ-47910382 90 mg (1.8 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

Placebo

Intervention Type: DRUG

Matching Placebo administered once daily as monotherapy for 5 days.

Panel 3

Study participants will receive double-blind treatment with JNJ-47910382 200 mg (maxiumum dose) or matching placebo. Participants in each of Panel will be treated sequentially.

Group Type: EXPERIMENTAL

JNJ-47910382 200 mg

Intervention Type: DRUG

JNJ-47910382 200 mg (4 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

Placebo

Intervention Type: DRUG

Matching Placebo administered once daily as monotherapy for 5 days.

Interventions

JNJ-47910382 30 mg

JNJ-47910382 30 mg (0.6 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

Intervention Type: DRUG

JNJ-47910382 90 mg

JNJ-47910382 90 mg (1.8 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

Intervention Type: DRUG

JNJ-47910382 200 mg

JNJ-47910382 200 mg (4 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.

Intervention Type: DRUG

Placebo

Matching Placebo administered once daily as monotherapy for 5 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Documented chronic HCV infection (diagnosis of hepatitis C >= 6 months before the screening period)
• HCV geno- and subtype of 1a or 1b (Panel 1) or 1b (Panels 2 and 3)
• Patient has never received pegylated interferon, ribavirin, or any other approved or investigational antiviral treatment for chronic HCV infection
• Patient with HCV ribonucleic acid (RNA) level of >100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay)
• A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included
• A body weight above 50 kg
• Normal 12-lead electrocardiogram (ECG) at screening

Exclusion Criteria

• Evidence of or documented liver cirrhosis
• Evidence of decompensated liver disease
• Evidence of any other cause of significant liver disease in addition to hepatitis C
• History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the Investigator's opinion would compromise patient's safety and/or compliance with the study procedures
• A positive urine drug (with exclusion of methadone or equivalent) test at study screening
• Patient with protocol-defined laboratory abnormalities at screening
• 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 (eg, cardiac dysfunction, cardio(myo)pathy, cardiac insufficiency), or medical history or physical examination findings during screening that, in the Investigator's opinion, would compromise the outcome of the trial
• Patient having uncontrolled/unstable disease such as diabetes, epilepsy, a manifest psychiatric disease, or thyroid disease or disorders
• Patient with non-stable methadone (or equivalent drug) use

• 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

Kaohsiung City, , Taiwan

Niaosung, Kaohsiung, , Taiwan

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

47910382HPC1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR100718

Identifier Type: -

Identifier Source: org_study_id