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

NCT ID: NCT01949610

Last Updated: 2013-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-03-31

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.

Detailed Description

This is a single-dose, 1-arm (group), open-label study (all people know the identity of the intervention) in healthy adult male participants. On Day 1, after completing a 10-hour overnight fast, participants will receive a single oral dose of 14C-JNJ-26489112 1,000 mg as a 10-mL suspension. Participants will be recruited in 2 cohorts. The 6 participants in the first cohort were dosed in error with doses less than 1000 mg. So, an additional cohort of 4 participants will be enrolled to receive a single oral dose of 1000 mg 14C-JNJ 26489112. Total 10 participants will receive the study medication. Safety will be assessed by monitoring vital signs, physical examinations, electrocardiograms, and clinical laboratory tests throughout the study. The total duration of the study for each participant will be approximately 5 weeks (including up to 3 weeks for screening and 11 to 15 days of study) or up to 1 additional week for participants who excrete 14C-JNJ26489112 more slowly.

Conditions

Healthy Participants

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

14C-JNJ26489112

Group Type: EXPERIMENTAL

14C-JNJ26489112

Intervention Type: DRUG

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

Interventions

14C-JNJ26489112

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Merksem, , Belgium

Countries

Belgium

Other Identifiers

26489112MDD1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR016981

Identifier Type: -

Identifier Source: org_study_id