Recruiting
Phase 1

Rilzabrutinib

Sponsor:

Sanofi

Code:

NCT07853131

Conditions

Renal Impairment

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

rilzabrutinib

Study Details

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

Study ID

NCT07853131

Start date

Sep 22, 2026

Status verified date

Oct, 2026

Completion date

Apr 21, 2027

Anticipated

Primary completion date

Apr 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with severe renal impairment

Treated with single dose of rilzabrutinib

experimental: Participants with normal renal function

Treated with single dose of rilzabrutinib

Interventions

rilzabrutinib

Pharmaceutical form: Tablet Route of administration: Oral

Primary outcome measure

  • Rilzabrutinib: AUC [ Time Frame: Until Day 2 ]

Central Contacts and Locations

Central contacts

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

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

Locations

Clinical Pharmacology of Miami- Site Number : 8400001

Recruiting

Hialeah, Florida, United States, 33014

More Information

Sponsor

Sanofi

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.