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

Study of an Investigational Study Drug in Adults With Severe Kidney Problems

Age
18 years - 75 years
Gender
All
Phase
Phase 1
Participants needed
16
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Study Overview

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).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Renal Impairment, Healthy Volunteers
  • Age: 18 years - 75 years
  • Gender: All

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.

The purpose of this research study is to learn how severe kidney problems affect the amount of an investigational study drug in the blood, and to check its safety and tolerability. The study is for adults ages 18 to 75 with stable severe chronic kidney disease who are not on dialysis, and for healthy adults with normal kidney function.

Participants will receive a single dose of the investigational study drug by mouth as a tablet. The study team will take blood samples to measure the drug level in the blood and will check for side effects.

Who can participate:
Adults ages 18 to 75 may be able to participate if they:

  • Have stable severe chronic kidney disease and are not on dialysis, or are healthy with normal kidney function (based on a clinical assessment)
  • Have a body weight and body mass index (BMI) within the study’s required ranges

Study timeline and visits:
Participation lasts about 30 days. This includes screening for up to 27 days, a 3-day study period with a single dose on day one, and a follow-up visit around day three (with a window up to day five).

Updated on 20 Oct 2026. Study ID: NCT07853131

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