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PF-04447943

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 28, 2018

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials5
Total Enrollment127
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02785770A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult SubjectsPHASE1 COMPLETED 44 — — Jun 29, 2016Oct 20, 2016Dec 28, 20181 United States
NCT01097876A Study To Evaluate The Safety, Tolerability And Plasma Drug Levels Of PF-04447943 When Administered With Donepezil To Healthy Volunteer SubjectsPHASE1 COMPLETED 24 — — Apr 1, 2010Jul 1, 2010Aug 4, 20101 Singapore
NCT00959803Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.PHASE1 COMPLETED 17 — — Aug 1, 2009Nov 1, 2009Dec 7, 20091 United States
NCT00886093A Study To Evaluate Whether Food Affects The Plasma Drug Levels Of A 35 mg Single Dose Of PF-04447943 Taken Orally In Healthy Adult ParticipantsPHASE1 COMPLETED 10 — — Apr 1, 2009May 1, 2009Jul 2, 20091 United States
NCT00832052A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.PHASE1 COMPLETED 32 — — Jan 1, 2009May 1, 2009Jun 12, 20091 United States
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Study Endpoints
Primary Endpoints
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose
0.5 hour post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose
1 hour post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose
2 hours post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose
3 hours post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose
4 hours post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose
8 hours post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose
12 hours post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose
24 hours post-dose

Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.

Steady state PF 04447943 Cmax and AUCtau.
up through day 44
Steady state Donepezil Cmax and AUCtau.
up through day 44
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical examinations, and adverse events.
up through day 44
AEs (spontaneous and solicited). Change from baseline in vital signs.
Day 0 to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm)
ECG and clinical safety laboratory endpoints, including a complete blood count, a full chemistry panel (including electrolytes and hepatic transaminases) and urinalysis.
Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm)
Pharmacokinetic (single): AUClast, Cmax, Tmax
Day 1 to day 5
Pharmacokinetic(multiple): AUCt, Cmax and Tmax on Days 1 and 7, and Ctrough on Days 2, 3, 4 and 7.
Day 1 to day 11
Pharmacokinetic endpoints include plasma PF-04447943 area under the curve (AUC), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax).
Up to 96 hours after drug administration
Safety endpoints include vital signs, ECGs, clinical laboratory tests, clinical evaluations and examinations, and adverse events.
Up to 96 hours after drug administration
Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests
For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
Pharmacokinetic endpoints include plasma PF-04447943 area udner the curve (AUCt ), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax)
For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14
Maximum plasma concentration (Cmax)
1 hour post dose day 4
Minimum plasma concentration ((Ctrough)
For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13
Fraction of the total dose excreted in urine (Fe) and the renal clearance (CLR), and, if the data permit, half-life and the observed exposure accumulation ratio (Ro), and fluctuation index (Cmax: Cmin ratio) following multiple doses
For cohorts 1-3, day 7; for cohort 4, day 14
Secondary Endpoints
Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo
0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo
0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose
Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo
0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-04447943 low doseEXPERIMENTAL25 mg of PF-04447943
PF-04447943 high doseEXPERIMENTAL100 mg of PF-04447943
PlaceboPLACEBO_COMPARATORMatching placebo for PF-04447943
MoxifloxacinACTIVE_COMPARATOR400 mg of moxifloxacin
Active PF-04447943EXPERIMENTAL -
Placebo PF-04447943PLACEBO_COMPARATOR -
Single doseEXPERIMENTAL3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.
Multiple doseEXPERIMENTAL3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
Sequence 1EXPERIMENTAL -
Sequence 2EXPERIMENTAL -
Cohort 1EXPERIMENTALSubjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
Cohort 2EXPERIMENTALSubjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
Cohort 3aEXPERIMENTALSubjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
Cohort 3bEXPERIMENTALSubjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
Cohort 4EXPERIMENTAL -
Interventions
NameTypeDescription
PF-04447943DRUGSingle oral dose of PF-04447943 administered as an extemporaneously prepared solution
PlaceboDRUGSingle oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
MoxifloxacinDRUGSingle oral dose of moxifloxacin administered as tablet
PF-04447943 25 mgDRUG25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3)
Placebo PFDRUGPlacebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects of non childbearing potential and/or healthy male subjects, between the ages of 18 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg. Exclusion Criteria: * Evidence or history of clinically significant hemato...

Countries:United StatesSingapore
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