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A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 in Healthy Male Participants

NCT ID: NCT02280018

Last Updated: 2015-01-30

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944 in healthy male participants after a single intravenous (\[IV\] within a vein) dose administration.

Detailed Description

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This is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), and single-center study. The study will consist of Screening Period (2 to 21 days prior to participants' dose administration), Double-blind Treatment Period (single dose of JNJ-49122944 or placebo on Day 1), and Safety Follow-up Period (4 to 7 days after discharge). The total duration of participation for each participant, including screening, will be up to approximately 4 weeks. Blood samples will be collected for assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Conditions

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Healthy

Keywords

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Healthy JNJ-49122944 Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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JNJ-49122944, 5 milligram (mg)

Single dose of 5 mg JNJ-49122944, administered as a 22.2 milliliter (mL) intravenous (IV) infusion over 45 minutes in the morning following an overnight fast.

Group Type EXPERIMENTAL

JNJ-49122944, 5 milligram (mg)

Intervention Type DRUG

Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.

Placebo

Placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes in the morning following an overnight fast.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.

Interventions

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JNJ-49122944, 5 milligram (mg)

Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.

Intervention Type DRUG

Placebo

Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male participant, aged 18 to 55 inclusive
* Participant must have a body Mass Index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2), inclusive, and body weight not less than 50 kg
* Participant must be deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1
* Participant agrees to protocol-defined use of effective contraception
* Participant should be non-nicotine user for 6 months prior to screening

Exclusion Criteria

* Participants with current or history of clinically significant medical illness
* Participants with history of drug or alcohol abuse within 5 years
* Routine consumption of greater than 450 milligram (mg) of caffeine per day by the participant
* Participants with recent vaccination or acute illness
* Blood donation or major blood loss within 3 months prior to study drug administration by the participant
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Merksem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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49122944EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

2014-002354-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR105925

Identifier Type: -

Identifier Source: org_study_id