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.
- 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.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study Of Three PF-05190457 Formulations In Healthy Volunteers | |||
| Official Title ICMJE | 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 | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science | |||
| Condition ICMJE | Diabetes Mellitus, Type 2 | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 16 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | November 2011 | |||
| Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 21 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Singapore | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01522807 | |||
| Other Study ID Numbers ICMJE | B3301007 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | January 2012 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
