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PF03635659

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 23, 2009

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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00864786Multiple Dose Healthy Volunteer Safety Pharmacokinetics StudyPHASE1 COMPLETED 50 — — Sep 1, 2008Mar 1, 2009Mar 23, 20091 Belgium
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Study Endpoints
Primary Endpoints
Safety and toleration: Adverse events, vital signs measurements (supine and standing), 12-lead ECGs, spirometry (FEV1, FVC), laboratory safety tests, physical examination, and subject-reported dry mouth assessment.
3 Weeks
Pharmacokinetics: Plasma: Cmax, Tmax, AUCinf, AUCτ, t½, accumulation ratio, linearity ratio.
3 Weeks
Pharmacodynamics: Salivary flow rate
3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL200 mcg
Cohort 2EXPERIMENTAL600 mcg
Cohort 3EXPERIMENTAL1000 mcg
Cohort 4EXPERIMENTALDose to be decided
Cohort 5EXPERIMENTALDose to be decided
Interventions
NameTypeDescription
PF03635659DRUGInhaled doses of 200 mcgQD
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical l...

Countries:Belgium
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