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PF-05190457

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Feb 1, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

PF-05190457 · 2 trials · 2 indications

Phase 1 2
NCT01522807A Study Of Three PF-05190457 Formulations In Healthy VolunteersDiabetes Mellitus, Type 2
COMPLETED16 Analytics
NCT01247896Single Dose Escalation Study of PF-05190457 in Healthy VolunteersDiabetes Mellitus, Type II
COMPLETED26 Analytics
PHASE1COMPLETED
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
Diabetes Mellitus, Type 2
NCT0152280716
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PHASE1COMPLETED
Single Dose Escalation Study of PF-05190457 in Healthy Volunteers
Diabetes Mellitus, Type II
NCT0124789626
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Study Endpoints

Primary Endpoints

The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit.
0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit.
0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit.
0 - 48 hours post dose
The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit.
0 - 48 hours post dose
Safety and tolerability of PF-05190457 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements
8 weeks
The single dose PK of PF-05190457 will be described by estimating parameters of AUC(0-infinity), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit
48 hour

Secondary Endpoints

The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit.
0 - 48 hours post dose
The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit.
0 - 48 hours post dose
Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated.
0 - 24 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
100 mg PF-05190457EXPERIMENTALThree fasted treatments and fed with the short-duration osmotic capsule
100 mg PF - 05190457EXPERIMENTALThree fasted treatments and fed with the long-duration osmotic capsule
ActiveEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-05190457DRUG100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
PlaceboDRUGSingle Dose Placebo
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m\^2, and weight above 50 kg. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, car...

Countries:SingaporeBelgium
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Frequently asked questions about PF-05190457

What is PF-05190457 used for?

PF-05190457 is an investigational small molecule being developed by Pfizer for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has been studied in healthy volunteers to evaluate its safety and tolerability.

Who makes PF-05190457?

PF-05190457 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule intended for the treatment of Type 2 Diabetes Mellitus.

What phase is PF-05190457 in?

PF-05190457 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed in healthy volunteers to assess the drug's safety, tolerability, and pharmacokinetics.

What clinical trials is PF-05190457 in?

PF-05190457 has been studied in two completed Phase 1 clinical trials. NCT01247896 was a single dose escalation study in healthy volunteers in Belgium, enrolling 26 participants. NCT01522807 evaluated three formulations of the drug in healthy volunteers in Singapore, enrolling 16 participants.

Is PF-05190457 the same as any other drug?

PF-05190457 is the primary identifier for this investigational compound. No alternative names have been reported for this drug in the available clinical trial information. It is being studied under this identifier in Pfizer's development program for Type 2 Diabetes Mellitus.