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

This study is currently recruiting participants.
Verified November 2013 by Janssen R&D Ireland
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01651767
First received: July 25, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: Placebo
Drug: JNJ-47910382
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase Ib, Randomized, Double-Blind, Placebo-Controlled Trial in Caucasian 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:
  • Determination of pharmacokinetics of JNJ-47910382 [ Time Frame: Up to 9 Days ] [ Designated as safety issue: No ]
    The pharmacokinetics of JNJ-47910382 after 5 consecutive days of administration in chronic HCV-genotype-1 infected patients in different doses and dose regimens will be determined.

  • Evaluation of the intrinsic antiviral activity of JNJ-47910382 [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Evaluation of the intrinsic antiviral activity of different doses and dose regimens of JNJ-47910382 in chronic HCV-genotype-1 infected subjects, as measured by the HCV RNA decrease from baseline (Day 1) over time.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • No secondary outcome measures will be reported. [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Placebo
Form=suspension, route=oral.
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
Experimental: 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.
Drug: Placebo
Form=suspension, route=oral.
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
Experimental: 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.
Drug: Placebo
Form=suspension, route=oral.
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
Experimental: 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.
Drug: Placebo
Form=suspension, route=oral.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651767

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
Germany
Not yet recruiting
Berlin, Germany
Withdrawn
Essen, Germany
Withdrawn
Freiburg, Germany
Recruiting
Hamburg, Germany
Recruiting
Kiel, Germany
Completed
Mainz, Germany
Withdrawn
München, Germany
Recruiting
Münster, Germany
Recruiting
Tübingen, Germany
Recruiting
Ulm, Germany
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: NCT01651767     History of Changes
Other Study ID Numbers: CR100760, 47910382HPC1002, 2011-005110-10
Study First Received: July 25, 2012
Last Updated: November 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014