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14C-JNJ26489112

Phase 1

Undisclosed | Small molecule | Other |Johnson & Johnson|Trials Updated: Oct 7, 2013

14C-JNJ26489112 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

14C-JNJ26489112 clinical trials

14C-JNJ26489112 · 1 trial · 1 indication

Phase 1 1
NCT01949610A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male ParticipantsHealthy Participants
COMPLETED10 Analytics
PHASE1COMPLETED
A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male Participants
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Study Endpoints

Primary Endpoints

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 Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
14C-JNJ26489112EXPERIMENTAL -

Interventions

NameTypeDescription
14C-JNJ26489112DRUGParticipants will receive single dose of oral suspension of 1000 mg (10 mL) of 14C-JNJ26489112 on Day 1.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 movemen...

Countries:Belgium
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Frequently asked questions about 14C-JNJ26489112

What is 14C-JNJ26489112?

14C-JNJ26489112 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy male participants. The compound is radiolabeled with carbon-14, a labeling approach used in early research to trace how a drug is absorbed, metabolized, and excreted by the body.

Who is developing 14C-JNJ26489112?

14C-JNJ26489112 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound. No partner or collaborator is identified for this asset.

What phase is 14C-JNJ26489112 in?

14C-JNJ26489112 is in Phase 1 clinical development. Its single recorded trial, NCT01949610, has been completed. The study was an open-label, uncontrolled Phase 1 trial, so it was not randomized and not double blinded. The compound is investigational and has not been approved by the FDA.

What clinical trial is 14C-JNJ26489112 in?

14C-JNJ26489112 has been evaluated in one clinical trial, NCT01949610, titled A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male Participants. The Phase 1 study enrolled 10 healthy male volunteers aged 18 years and older in Belgium and is now completed.

What was the 14C-JNJ26489112 trial designed to measure?

The Phase 1 trial NCT01949610 was designed to evaluate the absorption, metabolism, and excretion of 14C-JNJ26489112 in healthy male participants. It enrolled 10 volunteers in Belgium. The carbon-14 label allows researchers to track where the compound and its breakdown products go in the body after dosing.