Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation
Completed · Phase 1
Conditions studied: Dermatitis, Atopic
In brief
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 fasting conditions * To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the variant Phase 3 tablet formulation and the Phase 3 tablet formulation under fasting conditions * To estimate the effect of food on the amount of study drug in the blood after a single 200 mg dose of the commercial formulation Part B • To measure and compare the amount of study drug in the blood after a single 200 mg dose given as the commercial tablet formulation and the Phase 3 tablet formulation under fasting conditions Parts A \& B * To collect samples for genotyping (CYP2C19 and CYP2C9 - enzymes that metabolize \[break down\] certain medications) o Genotyping is the collection of a small sample of blood that contains your genes * To evaluate the safety and tolerability of the study drug after single 200 mg doses of the three different formulations given to healthy participants * To measure the amount of study drug in the blood after single doses of the different formulations * To collect exploratory samples for biobanking o Biobanking is the collection and storage of blood samples for possible future testing
Key facts
- Study ID
- NCT04065633
- Run by
- Pfizer
- People needed
- 46
- Starts
- 2019-07-18
- Expected to finish
- 2019-12-14
- Last updated by the study team
- 2020-01-07
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
You may not qualify if…
- 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
Where it is running
- New Haven Clinical Research Unit — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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