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14C-paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 8, 2011

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 Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00796029A Study of Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral DosePHASE1 COMPLETED 5Jul 1, 2003Jul 1, 2003Jun 8, 2011 -
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Study Endpoints
Primary Endpoints
To investigate the metabolic pathways of paliperidone and excretion of paliperidone and its metabolites in healthy adult male volunteers,both poor and extensive metabolizers for CYP2D6,after administration of a single 1 mg oral dose of 14C paliperidone
Secondary Endpoints
To evaluate the safety and tolerability of paliperidone, as well as the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure to paliperidone and its metabolites
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
14C-paliperidoneDRUG -
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Eligibility Criteria
Age Range40 Years — 60 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Dextromethorphan metabolic ratio of \>0.345 (poor metabolizer) or \<0.0255 (extensive metabolizer) * Body Mass Index: (weight \[kg\]/height \[m\]2) between 20 and 28 kg/m2, inclusive * Volunteers must have signed an informed consent document indicating that they understand the...

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