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PF-04937319 IR MST

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Mar 4, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

PF-04937319 IR MST · 1 trial · 1 indication

Phase 1 1
NCT02206607Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.Type 2 Diabetes Mellitus
COMPLETED39 Analytics
PHASE1COMPLETED
Study To Compare Single Dose Of Three Modified Release Formulations Of PF-04937319 With Immediate Release Material-Sparing-Tablet (IR MST) Formulation Previously Studied In Adults With Type 2 Diabetes Mellitus.
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose

AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose

MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.

Secondary Endpoints

Maximum Observed PF-04937319 Plasma Concentration (Cmax)
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-04937319 IR MSTEXPERIMENTALReference formulation
PF-04937319 MR 1EXPERIMENTALTest MR #1
PF-04937319 MR 2EXPERIMENTALTest MR #2
PF-04937319 MR 3EXPERIMENTALTest MR #3

Interventions

NameTypeDescription
PF-04937319 IR MSTDRUGImmediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
PF-04937319 MR 1DRUGModified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 2DRUGModified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
PF-04937319 MR 3DRUGModified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Adults with type 2 diabetes, on stable background metformin therapy either alone or in combination with another oral anti-diabetic agent (OAD) excluding thiazolidinediones (TZDs) Exclusion Criteria: * Patients with cardiovascular event within 6 months of screening * Patients...

Countries:United States
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Frequently asked questions about PF-04937319 IR MST

What is PF-04937319 IR MST used for?

PF-04937319 IR MST is an investigational small molecule being developed by Pfizer for the treatment of Type 2 Diabetes Mellitus. It is a modified release formulation of PF-04937319, intended for oral administration. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does PF-04937319 IR MST target?

PF-04937319 IR MST is a small molecule being studied for Type 2 Diabetes Mellitus. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its effects on glucose control in adult patients with Type 2 Diabetes Mellitus.

Who makes PF-04937319 IR MST?

PF-04937319 IR MST is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 2 Diabetes Mellitus.

What phase is PF-04937319 IR MST in?

PF-04937319 IR MST is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of Type 2 Diabetes Mellitus, and its safety and efficacy have not been established.

What clinical trials is PF-04937319 IR MST in?

PF-04937319 IR MST has been studied in one completed Phase 1 clinical trial, NCT02206607. This trial compared single doses of three modified release formulations of PF-04937319 with the immediate release material-sparing-tablet formulation in adults with Type 2 Diabetes Mellitus. The study enrolled 39 participants in the United States.

Is PF-04937319 IR MST the same as PF-04937319?

PF-04937319 IR MST is a specific formulation of PF-04937319, referred to as the immediate release material-sparing-tablet (IR MST) formulation. It was studied in a clinical trial comparing it with other modified release formulations of PF-04937319. The IR MST designation indicates the specific tablet formulation used in the study.