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

An Open-label, Multi-center, Phase 1 Pharmacokinetic and Tolerability Study of Rilzabrutinib Given as a Single Oral Dose in Participants With Severe Renal Impairment and in Matched Participants With Normal Renal Function

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).

Study Overview

• Status: Recruiting
• Conditions: Renal Impairment; Healthy Volunteers
• Intervention / Treatment: Drug: rilzabrutinib

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com

Study Locations

• United States
  • Florida
    • Hialeah, Florida, United States, 33014
      • Recruiting
      • Clinical Pharmacology of Miami- Site Number : 8400001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• If participants with severe renal impairment: Stable severe chronic kidney disease (no dialysis) assessed by medical history, physical examination, laboratory values.
• If participants with normal renal function: Certified as healthy by a comprehensive clinical assessment.
• Body weight between 50.0 and 115.0 kg, inclusive, if male, and between 40.0 and 100.0 kg, inclusive, if female, and BMI between 18.0 and 40.0 kg/m2, inclusive, at screening.
• Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• Regular intake of nicotine more than 10 mg per day and unable to stop smoking during the study (occasional smoker can be enrolled).

• History or presence of drug or alcohol abuse.

• If participants with severe renal impairment:

  • Uncontrolled cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness, unless the Investigator considers an abnormality to be not clinically significant.
  • Participants with a history of serious infection requiring intravenous therapy within 4 weeks of study enrollment.
  • Any significant change in chronic treatment medication within 14 days before inclusion.

• If participants with normal renal function

  • Any history or presence of clinically relevant hepatic or renal disease.
  • For participants 50 years of age and younger: Any history or presence of cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness, unless the Investigator considers an abnormality to be not clinically significant.
  • For participants above 50 years of age: Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness, unless the Investigator considers an abnormality to be not clinically significant.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with severe renal impairment; Treated with single dose of rilzabrutinib	Drug: rilzabrutinib; Pharmaceutical form: Tablet Route of administration: Oral; Other Names: SAR444671
Experimental: Participants with normal renal function; Treated with single dose of rilzabrutinib	Drug: rilzabrutinib; Pharmaceutical form: Tablet Route of administration: Oral; Other Names: SAR444671

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rilzabrutinib: AUC	area under the plasma concentration versus time curve	Until Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rilzabrutinib: Cmax		Until Day 2
Rilzabrutinib: unbound Cmax		Until Day 2
Rilzabrutinib: AUClast		Until Day 2
Rilzabrutinib: unbound AUC		Until Day 2
Rilzabrutinib: CL/F		Until Day 2
Rilzabrutinib: t1/2z		Until Day 2
Adverse events (AEs)	incl. Clinical laboratory evaluations, Vital signs, Electrocardiogram (ECG)	Until Day 3

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2026
• Primary Completion (Estimated): April 21, 2027
• Study Completion (Estimated): April 21, 2027

Study Registration Dates

• First Submitted: September 23, 2026
• First Submitted That Met QC Criteria: September 23, 2026
• First Posted (Actual): October 1, 2026

Study Record Updates

• Last Update Posted (Actual): October 23, 2026
• Last Update Submitted That Met QC Criteria: October 20, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: POP22852; 2026-525707-27 (Registry Identifier: CTIS); U1111-1333-2311 (Other Identifier: WHO UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No