A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
Status:
COMPLETED
Trial end date:
2024-04-23
Target enrollment:
Participant gender:
Summary
This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.
The total study duration per participant is expected to be up to 36 days, including:
* Screening: up to 4 weeks
* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.
* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.
* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study.