Bioavailability Study of PF-06651600 Formulations in Healthy Participants
NCT04004663
Last updated date
ABOUT THIS STUDY
The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period,
cross over design in a single cohort of approximately 12 healthy male or female participants
at a single center. Participants will be randomized into 1 of 4 sequences of treatment.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Healthy Volunteers
Sex
Females and Males
Age
18-55 years
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Advanced Information
Descriptive Information | |||||||
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Brief Title ICMJE | Bioavailability Study of PF-06651600 Formulations in Healthy Participants | ||||||
Official Title ICMJE | A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 RELATIVE TO TABLETS IN HEALTHY PARTICIPANTS | ||||||
Brief Summary | The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment. | ||||||
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 Volunteers | ||||||
Intervention ICMJE | Drug: PF-06651600
PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods | ||||||
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 | 12 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | October 11, 2019 | ||||||
Actual Primary Completion Date | October 11, 2019 (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 | Belgium | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04004663 | ||||||
Other Study ID Numbers ICMJE | B7981022 2019-001452-19 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | October 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |