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PF-06372865 or Placebo or Lorazepam

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 18, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

PF-06372865 or Placebo or Lorazepam · 1 trial · 1 indication

Phase 1 1
NCT01951144A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865Healthy
COMPLETED45 Analytics
PHASE1COMPLETED
A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865
Healthy
NCT0195114445
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time
0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Apparent Oral Clearance (CL/F)
0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Apparent Volume of Distribution (Vz/F)
0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Plasma Decay Half-Life (t1/2)
0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Area Under the Curve From Time Zero to 24 hours
0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours post-dose
Change in Saccadic Eye Movements (saccadic reaction time, saccadic peak velocity and saccadic inaccuracy)
0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Body Sway
0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Smooth Pursuit
0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Bond and Lader VAS
0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Adaptive Tracking
0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
Change in Visual Verbal Learning Test
1 and 6 hours post dose
Change in Pharmaco-EEG
0, 0.5, 1, 1.5, 2, 4, 6, 12 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1:EXPERIMENTALSingle ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
Cohort 2:EXPERIMENTALSingle ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
Cohort 3:EXPERIMENTALSingle ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.
Cohort 4 (optional cohort):EXPERIMENTALTwo single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865.

Interventions

NameTypeDescription
PF-06372865 or PlaceboDRUGPF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
PF-06372865 or Placebo or LorazepamDRUGLorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject * Su...

Countries:Netherlands
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