Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects
NCT01794364
ABOUT THIS STUDY
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- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including clinically significant drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at the time of dosing).
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Descriptive Information | ||||
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Brief Title ICMJE | Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects | |||
Official Title ICMJE | A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects | |||
Brief Summary | The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Experimental: Cohort A
Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state. Interventions:
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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 | 8 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2013 | |||
Actual Primary Completion Date | March 2013 (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 | NCT01794364 | |||
Other Study ID Numbers ICMJE | B4801009 | |||
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 | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |