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An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition

StatusRecruiting
PhasePhase 1
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Sanofi
284 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT07855250
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Healthy Volunteer
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov