- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01949610
A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male Participants
October 4, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Absorption, Metabolism, and Excretion of 14C-JNJ26489112 After a Single Oral Dose in Healthy Male Subjects
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Merksem, Belgium
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 14C-JNJ26489112
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Participants will receive single dose of oral suspension of 1000 mg (10 mL) of 14C-JNJ26489112 on Day 1.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics of 14C-JNJ-26489112 in plasma
Time Frame: 240 hours
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240 hours
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Mass balance after an oral dose of 14C-JNJ-26489112 as generated from recovery of total radioactivity excreted in urine and feces
Time Frame: 240 hours
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240 hours
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Routes of 14C-JNJ-26489112 elimination measured through total radioactivity concentrations in urine and feces
Time Frame: 240 hours
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240 hours
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Whole blood and plasma partitioning of total radioactivity through measurement of total radioactivity levels in blood
Time Frame: 240 hours
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240 hours
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Identification of major metabolites in plasma, urine, and feces
Time Frame: 240 hours
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240 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: Up to Day 15
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Up to Day 15
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Number of participants with a suicide-related outcome
Time Frame: Screening (Days -21 to -1), Day 2 and end-of-study (Day 15)
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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).
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Screening (Days -21 to -1), Day 2 and end-of-study (Day 15)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
September 20, 2013
First Submitted That Met QC Criteria
September 20, 2013
First Posted (Estimate)
September 24, 2013
Study Record Updates
Last Update Posted (Estimate)
October 7, 2013
Last Update Submitted That Met QC Criteria
October 4, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- CR016981
- 26489112MDD1001 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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