Rilzabrutinib for Severe Renal Impairment

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

Recruiting Phase 1 Interventional Study
Renal Impairment Healthy Volunteers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
16 (estimated)
Sponsor
Sanofi · Industry
Who this trial is looking for

This trial is looking for adults with severe kidney problems and those with normal kidney function. Participants will take a single dose of rilzabrutinib and be monitored for about 30 days.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have severe chronic kidney disease without dialysis.
  • I am a healthy adult aged 18 to 75.
  • My weight is between 50.0 and 115.0 kg if I am male, or between 40.0 and 100.0 kg if I am female.
  • My BMI is between 18.0 and 40.0.
  • I use contraception as needed.

You may not be able to join if

  • I smoke more than 10 mg of nicotine per day and can’t stop during the study.
  • I have a history of drug or alcohol abuse.
  • I have uncontrolled serious health issues, like heart or lung disease.
  • I have had a serious infection that needed IV treatment in the last 4 weeks.
  • I had a significant change in my medications in the last 14 days.
  • I have a history of major liver or kidney disease.
  • I experience frequent headaches or migraines.
  • I have had nausea or vomiting that keeps coming back.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 per…
Trial Locations
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Eligibility Criteria
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. * B…
Contacts

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

800-633-1610

Contact-US@sanofi.com

CONTACT