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Trial record 1 of 1 for:    NCT02206607
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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.

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ClinicalTrials.gov Identifier: NCT02206607
Recruitment Status : Completed
First Posted : August 1, 2014
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 30, 2014
First Posted Date  ICMJE August 1, 2014
Results First Submitted Date  ICMJE December 14, 2015
Results First Posted Date  ICMJE March 4, 2016
Last Update Posted Date March 4, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
  • Area under the curve (AUC) from time zero to infinity [ Time Frame: Day 1 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post AM dose in each period ]
    Area under the plasma concentration-time curve from zero to infinity following administration of three MR formulations [Test] each compared to IR MST [Reference] formulation
  • Weighted mean daily glucose (WMDG) [ Time Frame: Day 1 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post AM dose in each period ]
    WMDG is a measure of plasma glucose levels over time used to characterize the anti-diabetic effect of drug for three MR formulations [Test] each compared to IR MST [Reference] formulation
Change History Complete list of historical versions of study NCT02206607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2014)
  • Plasma Concentrations over time [ Time Frame: Day 1 at 0, 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post AM dose in each period ]
    Cmax (maximum), C5 (5 hours post AM dose), C16 (16 hours post AM dose), C24 (24 hours post AM dose), Cmax/C24 ratio for the three MR formulations [Test] each compared to IR MST [Reference] formulation
  • Tmax [ Time Frame: Day 1 in each period ]
    Time to reach maximum observed plasma concentration (Tmax) of PF-04937319
  • Terminal half-life (t1/2) [ Time Frame: Day 1 in each period ]
    Time required for the plasma concentration to decrease by one-half
  • Area under the curve from time zero to last quantifiable concentration (AUClast) [ Time Frame: Day 1 in each period ]
    Area under the plasma concentration-time profile from time zero to the time of the last measurable concentration (AUClast)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: PF-04937319 IR MST
    Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: PF-04937319 IR MST
    Reference formulation
    Intervention: Drug: PF-04937319 IR MST
  • Experimental: PF-04937319 MR 1
    Test MR #1
    Intervention: Drug: PF-04937319 MR 1
  • Experimental: PF-04937319 MR 2
    Test MR #2
    Intervention: Drug: PF-04937319 MR 2
  • Experimental: PF-04937319 MR 3
    Test MR #3
    Intervention: Drug: PF-04937319 MR 3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
39
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2014)
36
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02206607
Other Study ID Numbers  ICMJE B1621015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP