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PF-04991532 alone

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 7, 2011

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-04991532 alone · 1 trial · 2 indications

Phase 1 1
NCT01370343Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health VolunteersHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration versus time profile (AUC)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Max observed plasma concentration (Cmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose

Secondary Endpoints

Time of Cmax (Tmax)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Terminal elimination half-life (t1/2)
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hrs postdose
Total amount of unchanged drug excreted in the urine over 24 hours (Ae24)
0-8, and 8-24hr postdose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-04991532 aloneEXPERIMENTAL -
PF-04991532 + cyclosporineEXPERIMENTAL -

Interventions

NameTypeDescription
PF-04991532 aloneDRUGa single dose of 150 mg PF-04991532, fasted
PF-04991532 + cyclosporineDRUGa single dose of 150 mg PF-04991532 + a single dose of 600 mg cyclosporine, fasted
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse r...

Countries:Belgium
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Frequently asked questions about PF-04991532 alone

What is PF-04991532?

PF-04991532 is an investigational small molecule being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers for a drug interaction trial.

What is PF-04991532 used for?

PF-04991532 is being studied in healthy volunteers. The completed Phase 1 trial evaluated its pharmacokinetics when given with cyclosporine. The drug is not approved for any indication and remains in early clinical development.

Who makes PF-04991532?

PF-04991532 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange.

What phase is PF-04991532 in?

PF-04991532 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials currently listed for this drug.

What clinical trials is PF-04991532 in?

PF-04991532 has one completed Phase 1 trial, NCT01370343, which studied the effect of cyclosporine on the pharmacokinetics of PF-04991532 in healthy volunteers. The trial enrolled 12 participants in Belgium.

Is PF-04991532 FDA approved?

PF-04991532 is not FDA approved. It is an investigational drug that has completed a Phase 1 trial in healthy volunteers, but it remains in clinical development and has not been approved for any use.