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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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-03-27

No results posted yet for this study

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

Interventions

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

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

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.

Sponsors & Collaborators

  • Janssen R&D Ireland

    lead INDUSTRY

Principal Investigators

  • Janssen R&D Ireland Clinical Trial · Janssen R&D Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-25
Primary Completion
2014-04-21
Completion
2014-04-21

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586325 on ClinicalTrials.gov