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
| Registry | NCT01522807 |
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| Status | Completed |
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| Phase | Phase 1 |
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| Study type | Interventional; randomized, crossover, masking: triple, basic science |
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| Enrollment | 16 (Actual) |
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| Sponsor | Pfizer (Industry) |
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| Conditions | Diabetes Mellitus, Type 2 |
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| Interventions | PF-05190457 (Drug) |
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| Dates | start 2011-09-01, primary completion 2011-11-01, completion 2011-11-01, first posted 2012-02-01, last updated 2012-02-01 |
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| Locations | 1 site in Singapore |
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Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes Mellitus, Type 2 All trials of PF-05190457
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| 100 mg PF-05190457 | Experimental | Drug: PF-05190457 | Three fasted treatments and fed with the short-duration osmotic capsule |
| 100 mg PF - 05190457 | Experimental | Drug: PF-05190457 | Three fasted treatments and fed with the long-duration osmotic capsule |
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
- PF-05190457 (Drug): 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
+Outcome measures
Primary outcomes
- 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. [0 - 48 hours post dose]
- 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. [0 - 48 hours post dose]
- 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. [0 - 48 hours post dose]
- 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. [0 - 48 hours post dose]
Secondary outcomes
- 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. [0 - 48 hours post dose]
- 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. [0 - 48 hours post dose]
- Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated. [0 - 24 hours post dose]
+Eligibility
Sex: All, ages: 21 Years to 55 Years, accepts healthy volunteers
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.
+Locations (1)
| Facility | City | Country | Status |
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| Pfizer Investigational Site | Singapore | Singapore | |
+Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer