Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
NCT ID: NCT04390776
Last Updated: 2021-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
164 participants
INTERVENTIONAL
2020-09-28
2021-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment Sequence 1
PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3).
PF-06651600
PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Treatment Sequence 2
PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3).
PF-06651600
PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Treatment Sequence 3
PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2).
PF-06651600
PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Treatment Sequence 4
PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2).
PF-06651600
PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Interventions
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PF-06651600
PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
Eligibility Criteria
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Inclusion Criteria
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
Countries
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References
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Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9.
Related Links
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Other Identifiers
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B7981029
Identifier Type: -
Identifier Source: org_study_id
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