NCT01482611

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

5 months

First QC Date

October 24, 2011

Last Update Submit

February 18, 2013

Conditions

Hepatitis C Virus Infection

Keywords

Hepatitis C VirusJNJ-4791038247910382HPC1001HCVHepatitis CHep CHealthy participantsJapaneseCaucasians

Outcome Measures

Primary Outcomes (8)

  • Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested.

    Adverse Events (AEs) with onset during the treatment phase and AEs that have worsened since baseline will be analysed.

    As of Day1 till and including 30-35 days after last drug intake

  • PK parameters after increasing single oral doses of JNJ-47910382, from 10 mg up to the maximum tolerated dose or up to 600 mg or up to the dose that yields a plasma level that approaches the predefined maximum mean exposure of JNJ-47910382.

    PK characteristics of JNJ-47910382 are determined based on plasma levels at one time point (Day3, 4 and 5), at 2 time points (Day2) and at 11 time points (Day1). Standard PK parameters such as Cmax (maximal concentration), Tmax (time point at moment maximal concentration is reached), AUClast (Area Under the Curve from time point of drug administration up to the last time point with a measurable concentration post dosing) etc. will be determined.

    Measured on Day1 till and including Day5 (i.e. predose, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h, 72h and 96h post dose) in each session.

  • Change from baseline values for clinical laboratory parameters for each dose group.

    On Day1, 2 and 4 during treatment, on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).

  • Change from baseline values for ECG for each dose group.

    On Day-1, 1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session)..

  • Change from baseline values for vital signs for each dose group.

    On Day1, 2, 3 and 4 during treatment and on Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).

  • Change from baseline values for physical examination for each dose group.

    On Day-1, 4, Day of drop-out (i.e. from day of dosing in first session till 96h postdosing in last session) and on both Follow up visits (i.e. 10-14 days after last drug intake and 30-35 days after last drug intake).

  • Change from baseline values for cardia telemetry for each dose group.

    Day1 (12 hours post-dose)

  • Percentage of participants with adverse events as a measure of safety and tolerability of JNJ-47910382 for each dose tested.

    AEs with onset during the treatment phase and AEs that have worsened since baseline will be analysed.

    As of Day1 till and including 30-35 days after drop out (and Day of drop out can be from day of dosing in first session till 96h postdosing in last session)..

Secondary Outcomes (1)

  • Sequencing of genes that may affect safety, tolerability or PK of JNJ-47910382.

    Per participant, once during the conduct of the study, preferentially on Day-2 of one of the sessions.

Study Arms (4)

Panel 1: Caucasian

EXPERIMENTAL

10, 75 and 300 mg JNJ-47910382 or placebo

Drug: JNJ-47910382Drug: Placebo

Panel 2: Caucasian

EXPERIMENTAL

30, 150, 600 mg JNJ-47910382 or placebo

Drug: JNJ-47910382Drug: Placebo

Panel 3: Japanese

EXPERIMENTAL

Session VIII and X: Doses of JNJ-47910382 or placebo to be determined

Drug: JNJ-47910382Drug: Placebo

Panel 4: Japanese

EXPERIMENTAL

Session IX: Dose of JNJ-47910382 or placebo to be determined

Drug: JNJ-47910382Drug: Placebo

Interventions

JNJ-47910382DRUG

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

Panel 1: Caucasian
PlaceboDRUG

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

Panel 1: Caucasian

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caucasian subjects between 18 and 45 years of age, inclusive.
  • Japanese subjects between 20 and 45 years of age, inclusive.
  • MALE Japanese subjects who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese
  • A body weight above 50 kg at screening
  • Non-smoking for at least 3 months prior to screening

You may not qualify if:

  • Female Caucasian, except if postmenopausal for at least 2 years or be surgically sterile.
  • Hepatitis A, B or C infection
  • Human Immunodeficiency Virus Type 1 (HIV-1) or Human Immunodeficiency Virus Type 2 (HIV-2) infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, Germany

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

November 30, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

DE(1)