Rilzabrutinib in adults with severe kidney impairment vs. normal kidney function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label study has two arms: participants with severe renal impairment and matched participants with normal renal function. Each participant receives a single oral dose of rilzabrutinib, with a 3-day treatment period and a short follow-up to monitor safety and pharmacokinetics. The study lasts about 30 days per participant, including screening and follow-up windows. The goal is to compare drug exposure, safety, and tolerability between the two groups.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.