Back to resultsStudy 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.
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04937319 IR MST
PF-04937319 MR 1
PF-04937319 MR 2
PF-04937319 MR 3
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Phase 1, bioavailability, type 2 diabetes mellitus, PF-04937319
Eligibility 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)
Sites / Locations
- High Point Clinical Trials Center
- Clinical Trials of Texas, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
PF-04937319 IR MST
PF-04937319 MR 1
PF-04937319 MR 2
PF-04937319 MR 3
Arm Description
Reference formulation
Test MR #1
Test MR #2
Test MR #3
Outcomes
Primary Outcome Measures
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
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
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)
PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)
Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
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)
Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Terminal Elimination Half-Life (t1/2)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02206607
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Phase 1, bioavailability, type 2 diabetes mellitus, PF-04937319
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04937319 IR MST
Arm Type
Experimental
Arm Description
Reference formulation
Arm Title
PF-04937319 MR 1
Arm Type
Experimental
Arm Description
Test MR #1
Arm Title
PF-04937319 MR 2
Arm Type
Experimental
Arm Description
Test MR #2
Arm Title
PF-04937319 MR 3
Arm Type
Experimental
Arm Description
Test MR #3
Intervention Type
Drug
Intervention Name(s)
PF-04937319 IR MST
Intervention Description
Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
Intervention Type
Drug
Intervention Name(s)
PF-04937319 MR 1
Intervention Description
Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Intervention Type
Drug
Intervention Name(s)
PF-04937319 MR 2
Intervention Description
Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Intervention Type
Drug
Intervention Name(s)
PF-04937319 MR 3
Intervention Description
Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
Primary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
Description
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
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
Title
Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
Description
MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
Description
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 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
Title
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
Title
Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
Description
Area under the plasma concentration time-curve from zero to the last measured 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
Title
Terminal Elimination Half-Life (t1/2)
Description
t1/2 is the time measured for the plasma concentration to decrease by one half.
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
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 28 days after last study drug administration in Period 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
High Point Clinical Trials Center
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1621015
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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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