Phase 1Recruiting
An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
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
- Sponsor
- Sanofi (Industry)
- Enrolment
- 14 planned
- Conditions
- Healthy Volunteer
- Interventions
- Rilzabrutinib; Rosuvastatin; Digoxin
- Ages
- adults
- Registry
- NCT07855250
From the registry
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.
Primary outcomes
- AUC for digoxin and rosuvastatin
- AUClast for digoxin and rosuvastatin
- Cmax for digoxin and rosuvastatin