Bioavailability Study Of PF-06651600 In Healthy Subjects
NCT02684760
ABOUT THIS STUDY
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- Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Prior history of chicken pox.
- Evidence of personally signed and dated informed consent document.
- Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for males.
- Screening blood pressure >140/90 mm Hg.
- Screening laboratory abnormalities as defined by the protocol.
- Unwilling or unable to comply with the Lifestyle Guidelines as defined by the
protocol.
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Descriptive Information | ||||
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Brief Title ICMJE | Bioavailability Study Of PF-06651600 In Healthy Subjects | |||
Official Title ICMJE | A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects | |||
Brief Summary | PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: PF-06651600
PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. | |||
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 | 14 | |||
Original Estimated Enrollment ICMJE | 12 | |||
Actual Study Completion Date ICMJE | May 2016 | |||
Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02684760 | |||
Other Study ID Numbers ICMJE | B7981003 2015-004857-41 ( EudraCT Number ) | |||
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 | June 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |