Clinical trial NCT02206607: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1
bioavailability
type 2 diabetes mellitus
PF-04937319
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
timeFrame: 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
measure: Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1
timeFrame: 0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose
Secondary outcomes:
measure: Maximum Observed PF-04937319 Plasma Concentration (Cmax)
timeFrame: 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
measure: PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)
timeFrame: 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
measure: PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)
timeFrame: 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
measure: PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)
timeFrame: 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
measure: Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)
timeFrame: 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
measure: Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)
timeFrame: 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
measure: Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)
timeFrame: 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
measure: Terminal Elimination Half-Life (t1/2)
timeFrame: 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
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last study drug administration in Period 4
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: