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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02206607
First Posted: August 1, 2014
Last Update Posted: March 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: PF-04937319 IR MST Drug: PF-04937319 MR 1 Drug: PF-04937319 MR 2 Drug: PF-04937319 MR 3 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Open-label, Cross-over, Single-day Study Of Pf-04937319 To Characterize Relative Bioavailability, Tolerability, And Pharmacodynamics Of Four Oral Formulations In Adults With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] [ Time Frame: 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 [ Time Frame: 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 Outcome Measures:
  • Maximum Observed PF-04937319 Plasma Concentration (Cmax) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 24 Hours After Morning Dose (C24) [ Time Frame: 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 ]
  • Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24) [ Time Frame: 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 ]
    Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.

  • Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax) [ Time Frame: 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 ]
  • Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast) [ Time Frame: 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 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  • Terminal Elimination Half-Life (t1/2) [ Time Frame: 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 ]
    t1/2 is the time measured for the plasma concentration to decrease by one half.

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 28 days after last study drug administration in Period 4 ]
    An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.


Enrollment: 39
Study Start Date: September 2014
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04937319 IR MST
Reference formulation
Drug: PF-04937319 IR MST
Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
Experimental: PF-04937319 MR 1
Test MR #1
Drug: PF-04937319 MR 1
Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Experimental: PF-04937319 MR 2
Test MR #2
Drug: PF-04937319 MR 2
Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Experimental: PF-04937319 MR 3
Test MR #3
Drug: PF-04937319 MR 3
Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 with diabetic complications
  • Female subjects who are pregnant or planning to become pregnant
  • Subjects with unstable medical conditions (eg, hypertension)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206607


Locations
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02206607     History of Changes
Other Study ID Numbers: B1621015
First Submitted: July 30, 2014
First Posted: August 1, 2014
Results First Submitted: December 14, 2015
Results First Posted: March 4, 2016
Last Update Posted: March 4, 2016
Last Verified: February 2016

Keywords provided by Pfizer:
Phase 1
bioavailability
type 2 diabetes mellitus
PF-04937319

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases