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PF-05190457

Phase 1

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

PF-05190457 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Nov 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment42

FDA Designations

No designations recorded

PF-05190457 clinical trials

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 2Unlock trial analytics
PHASE1COMPLETED
Single Dose Escalation Study of PF-05190457 in Healthy Volunteers
Diabetes Mellitus, Type IIUnlock trial analytics

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 for Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has not been approved by regulatory authorities. Studies have been conducted in healthy volunteers to evaluate the drug's safety and pharmacokinetics.

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 currently in Phase 1 clinical trials for the treatment of Type 2 Diabetes Mellitus.

What phase is PF-05190457 in?

PF-05190457 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not received FDA approval. It is being studied for potential use in Type 2 Diabetes Mellitus.

What clinical trials is PF-05190457 in?

PF-05190457 has been studied in two completed Phase 1 trials. NCT01247896 was a single dose escalation study in 26 healthy volunteers in Belgium. NCT01522807 evaluated three formulations of the drug in 16 healthy volunteers in Singapore. Both trials were randomized, double-blind, and controlled.

Is PF-05190457 the same as another drug?

PF-05190457 is the primary identifier for this investigational compound. No alternative names have been reported in clinical trial registrations. The drug is being studied under this identifier in Phase 1 trials for Type 2 Diabetes Mellitus.