A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male Participants

NCT01949610 | Completed Phase 1

• 2 other identifiers: CR01698126489112MDD1001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the absorption, the metabolic pathways (a series of metabolic reactions) and the excretion of JNJ26489112 in healthy male adult participants after administration of a single oral dose of 1000 mg of 14C-JNJ26489112.

Conditions

Healthy Participants

Keywords

Healthy Participants; JNJ26489112; 14C-JNJ26489112; Absorption; Metabolism; Excretion

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics of 14C-JNJ-26489112 in plasma

  240 hours

• Mass balance after an oral dose of 14C-JNJ-26489112 as generated from recovery of total radioactivity excreted in urine and feces

  240 hours

• Routes of 14C-JNJ-26489112 elimination measured through total radioactivity concentrations in urine and feces

  240 hours

• Whole blood and plasma partitioning of total radioactivity through measurement of total radioactivity levels in blood

  240 hours

• Identification of major metabolites in plasma, urine, and feces

  240 hours

Secondary Outcomes (2)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to Day 15

• Number of participants with a suicide-related outcome

  Screening (Days -21 to -1), Day 2 and end-of-study (Day 15)

Study Arms (1)

14C-JNJ26489112

EXPERIMENTAL

Drug: 14C-JNJ26489112

Interventions

14C-JNJ26489112 DRUG

Participants will receive single dose of oral suspension of 1000 mg (10 mL) of 14C-JNJ26489112 on Day 1.

14C-JNJ26489112

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed an informed consent document indicating they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing to adhere to the prohibitions and restrictions specified in the protocol
• Had consistent bowel movement habit (approximately once per day) within 30 days before dosing
• Blood pressure (after the participant is supine for 5 minutes) is between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
• A 12-lead electrocardiogram consistent with normal cardiac conduction and function

You may not qualify if:

• Exposure to radiation for professional or medical reasons with the exception of up to 2 standard diagnostic radiographs (eg, dental X-rays, plain chest X-ray) or participation in any investigational study involving radioactivity within 1 year before study drug administration on Day 1
• History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center
• Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram at screening or at admission to the study center
• Clinically significant ocular deficits, including retinal disorders

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 7, 2013

Record last verified: 2013-10

Locations

BE (1)