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14C-JNJ26489112

Phase 1

Healthy Participants | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 7, 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

Clinical trial landscape

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 used for?

14C-JNJ26489112 is an investigational small molecule being studied in healthy participants. It is a radiolabeled compound used in a Phase 1 clinical trial to evaluate its absorption, metabolism, and excretion in the body. The study is not intended to treat a disease but to understand how the drug behaves in healthy male volunteers.

Who makes 14C-JNJ26489112?

14C-JNJ26489112 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research on this investigational small molecule drug.

What phase is 14C-JNJ26489112 in?

14C-JNJ26489112 is in Phase 1 clinical development. The single clinical trial for this drug has been completed. It is an investigational drug and has not been approved by regulatory authorities for any medical use.

What clinical trials is 14C-JNJ26489112 in?

14C-JNJ26489112 has one completed clinical trial registered as NCT01949610, titled "A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male Participants." This Phase 1 study enrolled 10 healthy male participants in Belgium and was not randomized or blinded.

How does 14C-JNJ26489112 work?

14C-JNJ26489112 is a radiolabeled small molecule, meaning it contains a radioactive carbon isotope (14C) that allows researchers to track the drug's absorption, metabolism, and excretion in the body. This helps scientists understand how the compound is processed after administration.