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An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
Sponsor: Sanofi
Summary
The study is a single-center, Phase-1, open-label, one-sequence, two-treatment period, cross-over, DDI study designed to investigate the effects of rilzabrutinib on the PK of digoxin (as P-gp substrate) and of rosuvastatin (as substrate of BCRP, OATP1B1, and OATP1B3) in healthy male and female participants. For this study a cocktail of digoxin and rosuvastatin will be used.
Official title: A Phase-1, Open-label, One-sequence, Two-treatment Period, Cross-over, Drug-drug Interaction Study to Evaluate the Effect of Oral Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Substrates in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2026-10-01
Completion Date
2026-11-03
Last Updated
2026-10-19
Healthy Volunteers
Yes
Conditions
Interventions
Rilzabrutinib
From Day 1 to Day 12 of Period 2
Rosuvastatin
Single dose on Day 1 of Period 1 and on Day 8 of Period 2
Digoxin
Single dose on Day 1 of Period 1 and on Day 8 of Period 2
Locations (1)
Investigational Site Number : 1240001
Québec, Quebec, Canada