Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function

Summary

The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75 years. The total duration of the study per participant will be approximately 30 days, including: A screening period of up to 27 days. A 3-day, open-label treatment period, with a single dose on Day 1. A 1-day follow-up period (Day 3) with an allowable 2-day window (ie, Day 3 to Day 5).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Renal Impairment
• Healthy Volunteers

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1

Ages

18 to 75 years

Sex

All

Healthy volunteers

Accepted

Sponsor

Sanofi

Last updated on ClinicalTrials.gov

October 23, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites