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

NCT07853131 | Not Yet Recruiting Phase 1

• 3 other identifiers: POP228522026-525707-27U1111-1333-2311
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Renal Impairment; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Rilzabrutinib: AUC

  area under the plasma concentration versus time curve

  Until Day 2

Secondary Outcomes (7)

• 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

Study Arms (2)

Participants with severe renal impairment

EXPERIMENTAL

Treated with single dose of rilzabrutinib

Drug: rilzabrutinib

Participants with normal renal function

EXPERIMENTAL

Treated with single dose of rilzabrutinib

Drug: rilzabrutinib

Interventions

rilzabrutinib DRUG

Pharmaceutical form: Tablet Route of administration: Oral

Also known as: SAR444671

Participants with normal renal function; Participants with severe renal impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 9, 2026
• Primary Completion (Estimated): April 21, 2027
• Study Completion (Estimated): April 21, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share