Study of Commercial and Phase 3 of PF-04965842 Formulations, Estimation of Effect of Food on Commercial Formulation

• Status: Completed
• Trial end date: 2019-12-14
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Body mass index (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).

• 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