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PF-03716539

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 2, 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 Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00783484A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult SubjectsPHASE1 COMPLETED 37 — — Oct 1, 2008May 1, 2009Jun 2, 20091 Belgium
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of escalating single oral doses of PF 03716539 administered as Extemporaneous Powder for Solution (EPS) in healthy adult subjects.
27 days
To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects.
6 days
Secondary Endpoints
To assess the potency of PF 03716539 for CYP3A4 inhibition utilizing single dose IV midazolam as a probe substrate for CYP3A4/5.
6 days
To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc.
8 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALPF-03716539 crossover, single dose escalation (doses subject to change).
Cohort 2EXPERIMENTALPF-03716539 crossover, single dose escalation (doses subject to change).
Cohort 3EXPERIMENTALMidazolam-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
Cohort 4EXPERIMENTALDarunavir-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
Cohort 5EXPERIMENTALMaraviroc-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change).
Cohort 6EXPERIMENTALMaraviroc-PF-03716539 drug-drug interaction (PF-03716539 200 mg).
Interventions
NameTypeDescription
PF-03716539DRUGPF-03716539 10 mg oral solution, single dose
PlaceboOTHERPlacebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose)
MidazolamDRUGMidazolam 1 mg IV, single dose
Midazolam + PF-03716539 (100 mg)DRUGMidazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose
Midazolam + PF-03716539 (50 mg)DRUGMidazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose
DarunavirDRUGDarunavir 600 mg tablet twice daily for 9 days (Days 1-9)
Darunavir + PF-03716539DRUGDarunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10)
MaravirocDRUGMaraviroc 150 mg tablet once daily for 6 days (Days 1-6)
Maraviroc +PF-03716539DRUGMaraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Total body weight \>50 kg (110 lbs). Exclusion Criteria: Pregnant or nursing females. females of childbearing potential. Evidence or hist...

Countries:Belgium
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