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PF-05180999

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: May 1, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

PF-05180999 · 2 trials · 2 indications

Phase 1 2
NCT01530529A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999Healthy
COMPLETED12 Analytics
NCT01429740A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy AdultsSchizophrenia
COMPLETED29 Analytics
PHASE1COMPLETED
A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Plasma Decay Half-Life (t1/2)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Composite (or profile) of Pharmacokinetics
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose on Day 1 and Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-05180999 Immediate-ReleaseEXPERIMENTAL -
PF-05180999 Modified-Release 1EXPERIMENTAL -
PF-05180999 Modified-Release 2EXPERIMENTAL -
PF-05180999 Modified-Release 1 With FoodEXPERIMENTAL -
PF-05180999EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-05180999DRUGSingle dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
PlaceboDRUGPlacebo oral solution or capsules
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female of non-childbearing potential Exclusion Criteria: * Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption

Countries:United States
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Frequently asked questions about PF-05180999

What is PF-05180999 used for?

PF-05180999 is an investigational small molecule being studied for use in schizophrenia and in healthy volunteers. It is in Phase 1 clinical development, with studies evaluating its safety, tolerability, and pharmacokinetics. The drug is not approved and remains in early-stage clinical testing.

Who makes PF-05180999?

PF-05180999 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy adults and in people with schizophrenia.

What phase is PF-05180999 in?

PF-05180999 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, one in healthy adults and one assessing a modified-release formulation, but the drug remains in early-stage testing.

What clinical trials is PF-05180999 in?

PF-05180999 has been studied in two completed Phase 1 clinical trials. NCT01429740 evaluated the safety, tolerability, and pharmacokinetics of single doses in healthy adults in the United States, with 29 participants. NCT01530529 assessed the relative bioavailability of a modified-release formulation in 12 healthy volunteers.

Is PF-05180999 the same as another drug?

PF-05180999 is the primary name for this investigational compound. No alternative names have been reported for this drug in the available clinical trial information. It is identified by its Pfizer code name, PF-05180999, in the studies registered under NCT01429740 and NCT01530529.