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-esreboxetine

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 7, 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 Enrollment4
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00800956Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of EsreboxetinePHASE1 COMPLETED 4 — — Jan 1, 2009Feb 1, 2009Apr 7, 20111 United States
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Study Endpoints
Primary Endpoints
Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible
Approx 10 days
Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible
Approx 10 days
Secondary Endpoints
Clinical safety data
Approx 10 days
Pharmacokinetic parameters of plasma esreboxetine metabolites if possible
Approx 10 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Single oral dose of [14C]-esreboxetineEXPERIMENTAL -
Interventions
NameTypeDescription
[14C]-esreboxetineDRUGSingle oral dose of 6mg esreboxetine in solution containing approximately 100uCi \[14C\]-esreboxetine
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Eligibility Criteria
Age Range45 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2 Exclusion Criteria: Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to signi...

Countries:United States
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