A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants

• Status: Not yet recruiting
• Trial end date: 2023-07-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults.

This study is seeking participants who are:

• aged 18 or older;

• male or female who are healthy as determined by medical assessment ;

• Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

The study will take up to 2.5 months, including the screening period. There will be 5 periods in total for this study. Participants will have to stay at the study clinic for at least 11 days. Participants will take Riltecitinib either as sprinkled in Soft Food or as Intact Blend-In Capsule. On day 1 of each period, participants will take Riltecitinib and have blood samples taken both before and afterwards. Participants will also answer questions for taste assessment purpose. A follow-up phone call will be made at 28 to 35 days after the last study period.

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

Details

• Lead Sponsor: Pfizer

Criteria

Key Inclusion Criteria:

1. Aged 18 or older.

2. Male or female who are healthy as determined by medical assessment.

3. Body-mass Index (BMI) of 16 to 32, and a total body weight > 45kg.

Key Exclusion Criteria:

1. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

3. Known immunodeficiency disorder, including positive serology for HIV, or a first degree relative with a hereditary immunodeficiency, or infections (acute or chronic).