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

Primary Purpose

Chronic Hepatitis C Infection

Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Placebo
JNJ-47910382
Sponsored by
Janssen R&D Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring Chronic hepatitis C virus infection, JNJ-47910382, Pharmacokinetics, Caucasian genotype-1, Non-structural protein 5A (NS5A) inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Panel I

Panel II

Panel III

Panel IV

Arm Description

Patients will be randomized to receive JNJ-47910382 at a dose of 30 mg or placebo as monotherapy once daily for 5 days.

Patients will be randomized to receive JNJ-47910382 at a dose of 90 mg or placebo as monotherapy once daily for 5 days.

Patients will be randomized to receive JNJ-47910382 at a dose of 300 mg or placebo as monotherapy once daily for 5 days.

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.

Outcomes

Primary Outcome Measures

Determination of pharmacokinetics of JNJ-47910382
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
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

Secondary Outcome Measures

Full Information

First Posted
July 25, 2012
Last Updated
May 9, 2014
Sponsor
Janssen R&D Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT01651767
Brief Title
Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
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
August 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (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 (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.
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.

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 virus infection, JNJ-47910382, Pharmacokinetics, Caucasian genotype-1, Non-structural protein 5A (NS5A) inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panel I
Arm Type
Experimental
Arm Description
Patients will be randomized to receive JNJ-47910382 at a dose of 30 mg or placebo as monotherapy once daily for 5 days.
Arm Title
Panel II
Arm Type
Experimental
Arm Description
Patients will be randomized to receive JNJ-47910382 at a dose of 90 mg or placebo as monotherapy once daily for 5 days.
Arm Title
Panel III
Arm Type
Experimental
Arm Description
Patients will be randomized to receive JNJ-47910382 at a dose of 300 mg or placebo as monotherapy once daily for 5 days.
Arm Title
Panel IV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form=suspension, route=oral.
Intervention Type
Drug
Intervention Name(s)
JNJ-47910382
Intervention Description
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
Primary Outcome Measure Information:
Title
Determination of pharmacokinetics of JNJ-47910382
Description
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.
Time Frame
Up to 9 Days
Title
Evaluation of the intrinsic antiviral activity of JNJ-47910382
Description
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.
Time Frame
Up to 4 weeks
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
Up to 4 weeks

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: 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
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
Hamburg
Country
Germany
City
Kiel
Country
Germany
City
Mainz
Country
Germany
City
Münster
Country
Germany
City
Tübingen
Country
Germany
City
Ulm
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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