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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

StatusNot Yet Recruiting
PhasePhase 1
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Sanofi
284 trials monitored
See 12 trials at risk
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).
Trial Details
NCT Number NCT07853131
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Renal Impairment, Healthy Volunteers
Related terms Renal Insufficiency
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov