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

NCT01651767 | Terminated Phase 1

• 3 other identifiers: CR10076047910382HPC10022011-005110-10
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 6

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.

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic hepatitis C virus infection; JNJ-47910382; Pharmacokinetics; Caucasian genotype-1; Non-structural protein 5A (NS5A) inhibitor

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 9 Days

• 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.

  Up to 4 weeks

• Number of participants with adverse events as a measure of safety and tolerability

  Up to 4 weeks

Study Arms (4)

Panel I

EXPERIMENTAL

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; Drug: JNJ-47910382

Panel II

EXPERIMENTAL

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; Drug: JNJ-47910382

Panel III

EXPERIMENTAL

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; Drug: JNJ-47910382

Panel IV

EXPERIMENTAL

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; Drug: JNJ-47910382

Interventions

Placebo DRUG

Form=suspension, route=oral.

Panel I; Panel II; Panel III; Panel IV

JNJ-47910382 DRUG

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

Panel I; Panel II; Panel III; Panel IV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (6)

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Ulm, Germany

Location

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

DE (6)