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14C-JNJ26489112

Phase 1

Healthy Participants | Small molecule | Other |Johnson & Johnson|Last Updated: Oct 7, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01949610A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male ParticipantsPHASE1 COMPLETED 10 — — Jan 1, 2010Mar 1, 2010Oct 7, 20131 Belgium
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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 — 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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