A study of three PF-05190457 formulations in healthy volunteers (clinicaltrials.gov) - Jan 29, 2012 - P1; N=16; Completed; New P1 trial
New trial • Diabetes
|
|
This study has been completed.
First Received on October 30, 2011. Last Updated on January 27, 2012 History of Changes
Sponsor: Pfizer
Information provided by (Responsible Party): Pfizer
ClinicalTrials.gov Identifier: NCT01522807
Purpose
The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.
Condition
Diabetes Mellitus, Type 2
Intervention
Drug: PF-05190457
Phase
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers
Resource links provided by NLM:
Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Diabetes Diabetes Type 2
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
•The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit. [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
•The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit. [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
•The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit. [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
•The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit. [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
•The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit. [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
•The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit. [ Time Frame: 0 - 48 hours post dose ] [ Designated as safety issue: No ]
•Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated. [ Time Frame: 0 - 24 hours post dose ] [ Designated as safety issue: No ]
Enrollment: 16
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
|