A Study Of Three PF-05190457 Formulations In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01522807
First received: October 30, 2011
Last updated: January 27, 2012
Last verified: January 2012
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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 | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: PF-05190457 |
Phase 1 |
| 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:
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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 100 mg PF-05190457
Three fasted treatments and fed with the short-duration osmotic capsule
|
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
|
|
Experimental: 100 mg PF - 05190457
Three fasted treatments and fed with the long-duration osmotic capsule
|
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
Drug: PF-05190457
100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
|
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01522807 History of Changes |
| Other Study ID Numbers: | B3301007 |
| Study First Received: | October 30, 2011 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Phase 1 Single Doses Biocomparison Pharmacokinetics Healthy Volunteers |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013