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

Chronic Hepatitis C Infection Clinical Trial

Official title:

A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Trial in Asian Genotype 1 Chronic HCV-Infected Subjects to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Repeated Doses of JNJ-47910382 Given in Different Doses and Dose Regimens

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01586325
• Other study ID #: CR100718
• Secondary ID: 47910382HPC1003
• Status: Terminated
• Phase: Phase 1
• Start date: May 25, 2012
• Est. completion date: April 21, 2014

Study information

• Verified date: March 2019
• Source: Janssen R&D Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 21, 2014
• Est. primary completion date: April 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• 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.
• 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.
• 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.
• Placebo
Matching Placebo administered once daily as monotherapy for 5 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen R&D Ireland

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HCV RNA levels over time during the 5-day treatment regimen		Up to 4 weeks after the last dose of study medication.
Primary	Number of participants with HCV RNA levels below the limit of detection		Up to 4 weeks after the last dose of study medication.
Secondary	Mean plasma concentrations of JNJ-47910382		Up to Day 9 of each treatment period.
Secondary	Maximum observed plasma concentration of JNJ-47910382		Up to Day 9 of each treatment period.
Secondary	Minimum observed plasma concentration of JNJ-47910382		Up to Day 9 of each treatment period
Secondary	Time to reach the maximum plasma concentration of JNJ-47910382		Up to Day 9 of each treatment period.
Secondary	Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-47910382		Up to Day 9 of each treatment period.
Secondary	Average steady-state plasma concentration of JNJ-47910382		Up to Day 9 of each treatment period.
Secondary	Terminal elimination half life of JNJ-47910382		Up to Day 9 of each treatment period.
Secondary	The number of participants affected by an adverse event		Up to 30 days after the last dose of study medication