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

NCT01586325 | Terminated Phase 1

• 2 other identifiers: CR10071847910382HPC1003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Hepatitis C Infection

Keywords

Chronic hepatitis C infection; Asian genotype 1 chronic hepatitis C infection; JNJ-47910382; Non-structural protein 5A (NS5A) inhibitor

Outcome Measures

Primary Outcomes (2)

• Change from baseline in HCV RNA levels over time during the 5-day treatment regimen

  Up to 4 weeks after the last dose of study medication.

• Number of participants with HCV RNA levels below the limit of detection

  Up to 4 weeks after the last dose of study medication.

Secondary Outcomes (8)

• Mean plasma concentrations of JNJ-47910382

  Up to Day 9 of each treatment period.

• Maximum observed plasma concentration of JNJ-47910382

  Up to Day 9 of each treatment period.

• Minimum observed plasma concentration of JNJ-47910382

  Up to Day 9 of each treatment period

• Time to reach the maximum plasma concentration of JNJ-47910382

  Up to Day 9 of each treatment period.

• Area under the plasma concentration-time curve from time 0 to 24 hours of JNJ-47910382

  Up to Day 9 of each treatment period.

Study Arms (3)

Panel 1

EXPERIMENTAL

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; Drug: Placebo

Panel 2

EXPERIMENTAL

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; Drug: Placebo

Panel 3

EXPERIMENTAL

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; Drug: Placebo

Interventions

JNJ-47910382 30 mg DRUG

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.

Panel 1

JNJ-47910382 90 mg DRUG

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.

Panel 2

JNJ-47910382 200 mg DRUG

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.

Panel 3

Placebo DRUG

Matching Placebo administered once daily as monotherapy for 5 days.

Panel 1; Panel 2; Panel 3

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (5)

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Niaosung, Kaohsiung, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 26, 2012
• Study Start: May 25, 2012
• Primary Completion: April 21, 2014
• Study Completion: April 21, 2014
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

TW (5)