Status:
COMPLETED
Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
Lead Sponsor:
Pfizer
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Part A * To measure and compare the amount of study drug in the blood after a single 200 mg dose of study drug given as the commercial tablet formulation and the Phase 3 tablet formulation under fast...
Detailed Description
The purpose of this study in healthy participants is to estimate the bioavailability (BA) of the commercial formulation of PF-04965842 and a variant formulation with slower dissolution relative to the...
Eligibility Criteria
Inclusion
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
Exclusion
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis
- Evidence or history of clinically significant dermatological condition (eg, atopic dermatitis or psoriasis) .History of tuberculosis (TB) (active or latent) or inadequately treated TB infection.
- History of chronic infections, history of recurrent infections, history of latent infections, .History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
- history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04065633
Start Date
July 18 2019
End Date
December 14 2019
Last Update
January 7 2020
Active Locations (1)
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1
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511