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PF-04991532 alone

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Sep 7, 2011

PF-04991532 alone development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2011

PF-04991532 alone target and mechanism

Molecular targetGCK
Target classActivator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

PF-04991532 alone clinical trials

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 developed by Pfizer, Inc. (ticker PFE). It is a glucokinase (GCK) activator that has been studied in Phase 1 clinical research. The specific disease or condition it is intended to treat has not been publicly disclosed, and it remains in early-stage clinical development.

What does PF-04991532 target?

PF-04991532 targets glucokinase, also known as GCK. It acts as a GCK activator, meaning it is designed to increase the activity of this enzyme. Glucokinase plays a role in glucose metabolism, which is why GCK activators are studied as a drug class.

Who makes PF-04991532?

PF-04991532 is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer sponsored the clinical research conducted on this compound, including a Phase 1 drug interaction study run in Belgium.

What phase is PF-04991532 in?

PF-04991532 is in Phase 1 clinical development. It is an investigational drug and is not approved by the FDA. Only one clinical trial has been recorded for this compound, and that trial is now completed, with no active trials currently listed.

What clinical trials is PF-04991532 in?

PF-04991532 has been studied in one completed Phase 1 trial, NCT01370343, titled a single dose study of the effect of cyclosporine on the pharmacokinetics of PF-04991532 in healthy volunteers. That trial enrolled 12 participants in Belgium and examined a drug interaction in healthy adults.

Was the PF-04991532 trial randomized and controlled?

Yes. The Phase 1 trial of PF-04991532, NCT01370343, was randomized and controlled, though it was not double-blind. It enrolled 12 healthy volunteers aged 18 years and older in Belgium and has been completed. No biomarker-based patient selection was used in this study.