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

Healthy Participants Clinical Trial

Official title:

Absorption, Metabolism, and Excretion of 14C-JNJ26489112 After a Single Oral Dose in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949610
• Other study ID #: CR016981
• Secondary ID: 26489112MDD1001
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2013
• Last updated: October 4, 2013
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: October 2013
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of 14C-JNJ-26489112 in plasma		240 hours	No
Primary	Mass balance after an oral dose of 14C-JNJ-26489112 as generated from recovery of total radioactivity excreted in urine and feces		240 hours	No
Primary	Routes of 14C-JNJ-26489112 elimination measured through total radioactivity concentrations in urine and feces		240 hours	No
Primary	Whole blood and plasma partitioning of total radioactivity through measurement of total radioactivity levels in blood		240 hours	No
Primary	Identification of major metabolites in plasma, urine, and feces		240 hours	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to Day 15	Yes
Secondary	Number of participants with a suicide-related outcome	Suicide related outcome measures will be assessed by using Columbia-Suicide Severity Rating Scale (C-SSRS). By using the C-SSRS, potential suicide-related events will be categorized using the codes defined by the Columbia Classification Algorithm of Suicide Assessment from Code 0: no event that can be assessed based on the C-SSRS to Code 9: not enough information, nonfatal. The 4 suicide-related outcomes of interest are the following: suicidal ideation (Code 4), suicidal behavior (Codes 1 to 3), suicidal behavior or ideation (Codes 1 to 4), and possible suicidal behavior or ideation (Codes 1 to 6 and 9).	Screening (Days -21 to -1), Day 2 and end-of-study (Day 15)	Yes