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A Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-38518168 After a Single Oral Dose in Healthy Male Participants.

NCT ID: NCT01970020

Last Updated: 2013-10-25

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of the study is to investigate the absorption, metabolism, and excretion of 14C JNJ-38518168 in healthy adult male participants after a single oral dose of 30 mg 14C JNJ-38518168.

Detailed Description

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This is an open-label (all people know the identity of the intervention), single-center, single-arm (single group), and single-dose study. This study will include a screening period of 21 days prior to study medication administration. Six men will be enrolled and admitted to the clinical study unit on the morning of Day -1. On Day 1, participants will receive a single oral solution dose containing 30 mg of 14C JNJ-38518168 given as an oral solution. The participants will be confined to the clinical study unit for at least 360 hours after dosing ie, Day -1 through Day 14 and they will be discharged on Day 15; however, participants who, by Day 15, do not meet the discharge criteria will extend their residency in the study unit for up to Day 21. They will return to the study center 7 to 10 days after discharge for the final safety follow-up. The study will include the following safety evaluations: adverse event, vital sign, 12-lead electrocardiography, physical examination, and clinical laboratory test. For each participant the total duration in the study is approximately 6 weeks (including screening and safety follow-up) or 7 weeks for participants who extend the residence up to Day 21.

Conditions

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Healthy

Keywords

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Healthy JNJ-38518168 14C-JNJ-38518168 Absorption Metabolism Excretion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JNJ-38518168

Group Type EXPERIMENTAL

JNJ-38518168

Intervention Type DRUG

Following an at least 10-hour overnight fast, participants will receive a single dose containing 30 mg of 14C JNJ-38518168 given as an oral solution on Day 1

Interventions

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JNJ-38518168

Following an at least 10-hour overnight fast, participants will receive a single dose containing 30 mg of 14C JNJ-38518168 given as an oral solution on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, male participants with a body mass index 18 to 30 kg/m2 (inclusive) and a body weight not less than 50 kg
* Must use adequate contraception and not donate sperm during study and for 90 days after receiving the study medication
* Non-smoker and blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* Have a 12-lead ECG consistent with normal cardiac conduction and function at screening

Exclusion Criteria

* Exposure to radiation for professional or medical reasons in the past 12 months
* Recent changes in bowel habits (frequency, consistency, and amount) and irregular defecation pattern (less than one defecation per day)
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease and coagulation disorders
* History of malignancy within 5 years before screening
* Has received a Bacille Calmette-Guérin vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks prior to the first administration of study agent
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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38518168ARA1004

Identifier Type: OTHER

Identifier Source: secondary_id

CR100989

Identifier Type: -

Identifier Source: org_study_id