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A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382

NCT01482611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-02-20

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a JNJ-47910382 plasma level that approaches the predefined maximum mean exposure (whichever comes first) in healthy Caucasian and Japanese participants. The foreseen maximum dose is 600 mg. In addition, the effect of fasting (ie JNJ-47910382 is taken without food) on the plasma pharmacokinetics of JNJ-47910382 after one selected oral dose given to healthy Caucasian participants will be studied. JNJ-47910382 is a drug that is being developed to treat Hepatitis C infection and is an inhibitor of the reproduction machinery of the Hepatitis C virus (HCV). Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

JNJ-47910382

Type = exact number, unit = mg, number = 10, 75, 300, form = suspension, route = oral use.

DRUG

JNJ-47910382

Type = exact number, unit = mg, number = 30, 150, 600, form = suspension, route = oral use.

DRUG

JNJ-47910382

Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use.

DRUG

JNJ-47910382

Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use.

DRUG

Placebo

Type = exact number, unit = mg, number = equivalent of 10, 75, 300, form = suspension, route = oral use.

DRUG

Placebo

Type = exact number, unit = mg, number = equivalent of 30, 150, 600, form = suspension, route = oral use

DRUG

Placebo

Type = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use.

DRUG

Placebo

Type = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use

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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Germany

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 NCT01482611 on ClinicalTrials.gov