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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Janssen R&D Ireland
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01586325
First received: April 24, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: JNJ-47910382 30 mg
Drug: JNJ-47910382 90 mg
Drug: JNJ-47910382 200 mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean plasma concentrations of JNJ-47910382 [ Time Frame: Up to Day 9 of each treatment period. ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration of JNJ-47910382 [ Time Frame: Up to Day 9 of each treatment period. ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration of JNJ-47910382 [ Time Frame: Up to Day 9 of each treatment period ] [ Designated as safety issue: No ]
  • Time to reach the maximum plasma concentration of JNJ-47910382 [ Time Frame: Up to Day 9 of each treatment period. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Average steady-state plasma concentration of JNJ-47910382 [ Time Frame: Up to Day 9 of each treatment period. ] [ Designated as safety issue: No ]
  • Terminal elimination half life of JNJ-47910382 [ Time Frame: Up to Day 9 of each treatment period. ] [ Designated as safety issue: No ]
  • The number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
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.
Drug: Placebo
Matching Placebo administered once daily as monotherapy for 5 days.
Experimental: 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.
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.
Drug: Placebo
Matching Placebo administered once daily as monotherapy for 5 days.
Experimental: 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.
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.
Drug: Placebo
Matching Placebo administered once daily as monotherapy for 5 days.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586325

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
Taiwan
Recruiting
Kaohsiung, Taiwan
Recruiting
Niaosung, Kaohsiung, Taiwan
Recruiting
Taichung, Taiwan
Recruiting
Tainan, Taiwan
Completed
Taipei, Taiwan
Withdrawn
Tao-Yuan, Taiwan
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01586325     History of Changes
Other Study ID Numbers: CR100718, 47910382HPC1003
Study First Received: April 24, 2012
Last Updated: July 10, 2014
Health Authority: Taiwan: Center for Drug Evaluation

Keywords provided by Janssen R&D Ireland:
Chronic hepatitis C infection
Asian genotype 1 chronic hepatitis C infection
JNJ-47910382
Non-structural protein 5A (NS5A) inhibitor

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014