drugset / Trial / NCT07855250
An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition
NaSingle-groupOpen-labelBasic science
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.
Timeline
- Start
- 2026-10-01
- Primary completion
- 2026-11-03
- Completion
- 2026-11-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Digoxin | Other / unclassified | — | — |
| Subject | Rilzabrutinib | Unknown | — | Oral |
| Subject | Rosuvastatin | Small molecule | — | — |
Indications
No indication recorded.