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CompletedNCT01949610Updated Oct 7, 2013

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

A Phase 1 interventional study of 14C-JNJ26489112 in Healthy Participants, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-07.

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • Healthy Participants
  • JNJ26489112
  • 14C-JNJ26489112
  • Absorption
  • Metabolism
  • Excretion
03

In context

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    14C-JNJ26489112

    Drug: 14C-JNJ26489112

Interventions

  • Drug14C-JNJ26489112

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

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics of 14C-JNJ-26489112 in plasma

    Time frame: 240 hours

  2. 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

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

    Time frame: 240 hours

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

    Time frame: 240 hours

  5. Identification of major metabolites in plasma, urine, and feces

    Time frame: 240 hours

Secondary outcomes

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

    Time frame: Up to Day 15

  2. 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).

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

07

Study locations

1 site
  • Merksem, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01949610
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Responsible party
Sponsor
First posted
Sep 24, 2013
Start date
Jan 2010
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Oct 7, 2013

Study contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
study director · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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