Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
NCT04390776
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
dermatological, or allergic disease (including drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- Known immunodeficiency disorder, including positive serology for human
immunodeficiency virus (HIV) at screening, or a first degree relative with a
hereditary immunodeficiency.
Participants with any of the following acute or chronic infections or infection history:
- Any infection requiring treatment within 2 weeks prior to the dosing visit.
- Any infection requiring hospitalization or parenteral antimicrobial therapy within 60
days of the first dose of study intervention.
- Any infection judged to be an opportunistic infection or clinically significant by the
investigator, within the past 6 months of the first dose of study intervention.
- Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other
infections.
- History of recurrent (more than one episode of) localized dermatomal herpes zoster, or
history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
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Descriptive Information | |||||
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Brief Title ICMJE | Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules. | ||||
Official Title ICMJE | A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE-DOSE STUDY TO EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS | ||||
Brief Summary | The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort. | ||||
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 Participants | ||||
Intervention ICMJE | Drug: PF-06651600
PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules. | ||||
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 | Recruiting | ||||
Estimated Enrollment ICMJE | 118 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 22, 2021 | ||||
Estimated Primary Completion Date | March 22, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Participants with any of the following acute or chronic infections or infection history:
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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 |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04390776 | ||||
Other Study ID Numbers ICMJE | B7981029 | ||||
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 | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |