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ACTIVE_NOT_RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Sanofi • ClinicalTrials.gov ID: NCT07855250

Registry updated: 2026-10-21
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Description

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.

Interventions

  • Rilzabrutinib (Drug)
    From Day 1 to Day 12 of Period 2
  • Rosuvastatin (Drug)
    Single dose on Day 1 of Period 1 and on Day 8 of Period 2
  • Digoxin (Drug)
    Single dose on Day 1 of Period 1 and on Day 8 of Period 2

Eligibility criteria

Inclusion Criteria * Participant must be 18 to 55 years of age inclusive. * Body weight between 50.0 and 100.0 kg for males, 40.0 and 90.0 kg for females. * Contraceptive use by male and female participants should be consistent with local regulations Exclusion Criteria * History of serious infections requiring intravenous therapy. * Frequent headaches, migraine, nausea or vomiting. * Blood donation within 1 month before inclusion. * History of drug hypersensitivity or allergic disease. * History of drug or alcohol abuse. * Smoking regularly more than 5 cigarettes or equivalent in nicotine per week * Excessive consumption of beverages containing xanthine bases. * Pregnancy or breastfeeding. * Recent vaccinations. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Conditions

Healthy Volunteer

Locations

  • Investigational Site Number : 1240001 — Québec, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record