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A Study to Investigate the Pharmacokinetics of JNJ-42396302, JNJ-53773187 and JNJ-42692507 in Healthy Male Participants

NCT ID: NCT01732237

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of the study is to investigate the pharmacokinetics (what the body does to the medication) of JNJ-42396302, JNJ-53773187 and JNJ-42692507 after administration of a single oral dose of 100 micrograms under fasted conditions in healthy male participants.

Detailed Description

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This is a phase I, open-label (all people know the identity of the intervention) and parallel-group (each group of patients will be treated at the same time), randomized (the study medication is assigned by chance) study in healthy male participants, to investigate the pharmacokinetics of a single oral dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507. The study consists of 3 phases, ie, screening phase (21 days prior to first dose of study medication), a treatment phase, and a follow up phase. In the treatment phase, participants will be divided into 3 treatment groups with 6 participants each, to receive a single dose of 100 micrograms of JNJ-42396302, JNJ-53773187 or JNJ-42692507 following an overnight fast of at least 10 hours. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be approximately 4 weeks.

Conditions

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Healthy

Keywords

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Healthy JNJ-42396302 JNJ-42692507 JNJ-53773187 Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JNJ-42396302

Patients will receive JNJ-42396302 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

JNJ-42396302

Intervention Type DRUG

A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

JNJ-42692507

Patients will receive JNJ-42692507 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

JNJ-42692507

Intervention Type DRUG

A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

JNJ-53773187

Patients will receive JNJ-53773187 100 micrograms as a single oral dose after an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

JNJ-53773187

Intervention Type DRUG

A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

Interventions

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JNJ-42396302

A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

Intervention Type DRUG

JNJ-42692507

A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

Intervention Type DRUG

JNJ-53773187

A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant should be healthy male on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis
* Participant must have a Body Mass Index of 18.5 to 30.0 kg/m2
* Have a blood pressure between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria

* A positive human immunodeficiency virus-type 1 or type 2 test and Hepatitis A, B or C infection at screening or admission
* Participant with abnormal physical, vital or laboratory values
* Currently active cardiovascular, bronchospastic respiratory disease, dyspnea, diabetes mellitus, movement disorder and infectious disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen-Cilag International NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Other Identifiers

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42396302EDI1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR100878

Identifier Type: -

Identifier Source: org_study_id