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Clinical Trial Details

Trial ID: L6209
Source ID: NCT02206607
Associated Drug: Pf-04937319 Ir Mst
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.
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02206607/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: PF-04937319 IR MST|DRUG: PF-04937319 MR 1|DRUG: PF-04937319 MR 2|DRUG: PF-04937319 MR 3
Outcome Measures: Primary: 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., 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|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., 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose | Secondary: 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|PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24), 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), 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., 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|Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax), 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), Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast), 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|Terminal Elimination Half-Life (t1/2), t1/2 is the time measured for the plasma concentration to decrease by one half., 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|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., Baseline up to 28 days after last study drug administration in Period 4
Sponsor/Collaborators: Sponsor: Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 39
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2014-09
Completion Date: 2015-01
Results First Posted: 2016-03-04
Last Update Posted: 2016-03-04
Locations: High Point Clinical Trials Center, High Point, North Carolina, 27265, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States
URL: https://clinicaltrials.gov/show/NCT02206607