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

An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-38518168 in Healthy Subjects Following a Single Oral Dose Administration of 14C-JNJ-38518168

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-38518168

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-38518168	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed concentration of 14C JNJ-38518168 in plasma		Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
Time to reach the maximum observed concentration of 14C JNJ-38518168 in plasma		Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
Area under the concentration-time curve		Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
Amount of 14C JNJ-38518168 excreted into the urine during a collection interval	Amount excreted into the urine during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the urinary volume with the urinary concentration for that interval.	Predose and from 0- to 4, 4- to 8, 8- to 12, 12- to 24, 24- to 36, 36- to 48 hours after dosing, and every 24 hours (pooled for 24-hour interval) thereafter until 336 hours post-dose
Amount of 14C JNJ-38518168 excreted into the feces during a collection interval	Amount excreted into the feces during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the feces weight with the feces concentration for that interval	From Day -1 through Day 14
Amount excreted into the vomit during a collection interval (applicable only for participants who experience vomitting)	Amount excreted into the vomit during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the weight of the vomit with the vomit concentration for that interval	Within 24 hours after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Up to 7 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: October 22, 2013
• First Posted (Estimate): October 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 25, 2013
• Last Update Submitted That Met QC Criteria: October 22, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Healthy; Absorption; Metabolism; Excretion; JNJ-38518168; 14C-JNJ-38518168
• Other Study ID Numbers: CR100989; 38518168ARA1004 (Other Identifier: Janssen Research & Development, LLC)