Back to resultsA 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
Primary Purpose
Chronic Hepatitis C Infection
Status
Terminated
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
JNJ-47910382 30 mg
JNJ-47910382 90 mg
JNJ-47910382 200 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Chronic hepatitis C infection, Asian genotype 1 chronic hepatitis C infection, JNJ-47910382, Non-structural protein 5A (NS5A) inhibitor
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Panel 1
Panel 2
Panel 3
Arm Description
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).
Study participants will receive double-blind treatment with JNJ-47910382 90 mg or matching placebo. Participants in each of Panel will be treated sequentially.
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.
Outcomes
Primary Outcome Measures
Change from baseline in HCV RNA levels over time during the 5-day treatment regimen
Number of participants with HCV RNA levels below the limit of detection
Secondary Outcome Measures
Mean plasma concentrations of JNJ-47910382
Maximum observed plasma concentration of JNJ-47910382
Minimum observed plasma concentration of JNJ-47910382
Time to reach the maximum plasma concentration of JNJ-47910382
Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-47910382
Average steady-state plasma concentration of JNJ-47910382
Terminal elimination half life of JNJ-47910382
The number of participants affected by an adverse event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01586325
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Because of many competing trials using the same mechanism of action, but being further advanced in development
Study Start Date
May 25, 2012 (Actual)
Primary Completion Date
April 21, 2014 (Actual)
Study Completion Date
April 21, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen R&D Ireland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection
Keywords
Chronic hepatitis C infection, Asian genotype 1 chronic hepatitis C infection, JNJ-47910382, Non-structural protein 5A (NS5A) inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Panel 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Panel 2
Arm Type
Experimental
Arm Description
Study participants will receive double-blind treatment with JNJ-47910382 90 mg or matching placebo. Participants in each of Panel will be treated sequentially.
Arm Title
Panel 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JNJ-47910382 30 mg
Intervention Description
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
Intervention Name(s)
JNJ-47910382 90 mg
Intervention Description
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
Intervention Name(s)
JNJ-47910382 200 mg
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo administered once daily as monotherapy for 5 days.
Primary Outcome Measure Information:
Title
Change from baseline in HCV RNA levels over time during the 5-day treatment regimen
Time Frame
Up to 4 weeks after the last dose of study medication.
Title
Number of participants with HCV RNA levels below the limit of detection
Time Frame
Up to 4 weeks after the last dose of study medication.
Secondary Outcome Measure Information:
Title
Mean plasma concentrations of JNJ-47910382
Time Frame
Up to Day 9 of each treatment period.
Title
Maximum observed plasma concentration of JNJ-47910382
Time Frame
Up to Day 9 of each treatment period.
Title
Minimum observed plasma concentration of JNJ-47910382
Time Frame
Up to Day 9 of each treatment period
Title
Time to reach the maximum plasma concentration of JNJ-47910382
Time Frame
Up to Day 9 of each treatment period.
Title
Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-47910382
Time Frame
Up to Day 9 of each treatment period.
Title
Average steady-state plasma concentration of JNJ-47910382
Time Frame
Up to Day 9 of each treatment period.
Title
Terminal elimination half life of JNJ-47910382
Time Frame
Up to Day 9 of each treatment period.
Title
The number of participants affected by an adverse event
Time Frame
Up to 30 days after the last dose of study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen R&D Ireland Clinical Trial
Organizational Affiliation
Janssen R&D Ireland
Official's Role
Study Director
Facility Information:
City
Kaohsiung
Country
Taiwan
City
Niaosung, Kaohsiung
Country
Taiwan
City
Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
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
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