A Multiple Dose Study Of PF-05161704 In Healthy Volunteers
NCT01202266
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight >50 kg (110 lbs.)
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- History or evidence of habitual use of tobacco or nicotine containing products within
3 months of screening or positive cotinine test at screening or Day -1.
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Descriptive Information | ||||
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Brief Title ICMJE | A Multiple Dose Study Of PF-05161704 In Healthy Volunteers | |||
Official Title ICMJE | A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers | |||
Brief Summary | The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, 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 | Terminated | |||
Actual Enrollment ICMJE | 32 | |||
Original Estimated Enrollment ICMJE | 96 | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2010 (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 | 18 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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01202266 | |||
Other Study ID Numbers ICMJE | B2911002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |