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PF-04287881

Phase 1

Respiratory Tract Infections | Small molecule | Other |Pfizer, Inc.|Last Updated: May 4, 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
RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment119
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01026545Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult SubjectsPHASE1 COMPLETED 39 — — Dec 1, 2009Jul 1, 2010May 4, 20111 United States
NCT00793000Safety And Pharmacokinetics Study Of PF-04287881 In Healthy AdultsPHASE1 COMPLETED 80 — — Nov 1, 2008Dec 1, 2009May 4, 20111 United States
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Study Endpoints
Primary Endpoints
Standard safety assessments including assessment of AEs, laboratory tests, ECGs, and vital signs.
Screening, Dosing days 1-10, through follow-up
The primary pharmacokinetic endpoints to be evaluated for PF-04287881 include Cmax, Tmax, and AUC(0-24) on Day 1 and Day 10.
Day 1 and 10
Evaluation of safety and tolerability of PF-04287881 after single oral dose.
Daily up to discharge, follow-up 7-10 days after dosing
Secondary Endpoints
Secondary parameters include AUCinf and t1/2 as data permit, apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) and accumulation ratio (Rac).
Days 1, 5 and 10
Urine concentrations of PF 04287881 in Cohorts 2 and 5 will be used to determine total amount excreted (Ae), %Ae relative to dose given and renal clearance (CLR).
Day 10
Concentrations of PF 04287881 will be measured in white blood cell (WBC) polymorphonuclear cells (PMNs) in Cohorts 2 and 5 to determine total exposure in WBC.
Days 1 and 10
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4 (optional)EXPERIMENTALIf intermediate or repeat dose level is needed; dose will not exceed 1100 mg.
Cohort 5 (Japanese)EXPERIMENTAL -
Cohort 6 (Japanese)EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -
Cohort 6EXPERIMENTAL -
Cohort 7EXPERIMENTAL -
Cohort 8EXPERIMENTALJapanese volunteers, low dose previously tested (based on PK)
Cohort 9EXPERIMENTALJapanese volunteers, intermediate dose previously tested (based on PK)
Cohort 10EXPERIMENTALJapanese volunteers, high dose previously tested (based on safety)
Interventions
NameTypeDescription
PF-04287881DRUG500 mg once daily for 10 days
PlaceboDRUGTo match 500 mg dose once daily for 10 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule. * Women of non-childbearing potential only. * Japanese subjects must have 4 Japanese grandparents who were born in Japan. Exclusion Criteria: * Previous antibiotic use wi...

Countries:United States
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