Renal ImpairmentPhase 1NCT07853131
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
A Phase 1 study testing rilzabrutinib in people with Renal Impairment and Healthy Volunteers, run by Sanofi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Healthy Volunteers
- What is being tested?
- rilzabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2026to 21 Apr 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
United States1 site, 1 recruiting
- Recruiting
Clinical Pharmacology of Miami- Site Number : 8400001
Hialeah, Florida, 33014
About this study
Official title: An Open-label, Multi-center, Phase 1 Pharmacokinetic and Tolerability Study of Rilzabrutinib Given as a Single Oral Dose in Participants With Severe Renal Impairment and in Matched Participants With Normal Renal Function
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
- Being tested
- rilzabrutinib
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rilzabrutinibDrug
Also called SAR444671
Pharmaceutical form: Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Participants with severe renal impairment | Experimental | Treated with single dose of rilzabrutinib Receives: Drug: rilzabrutinib |
| Participants with normal renal function | Experimental | Treated with single dose of rilzabrutinib Receives: Drug: rilzabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rilzabrutinib: AUC
area under the plasma concentration versus time curve
Measured: Until Day 2
Secondary outcomes (7)
Rilzabrutinib: Cmax
Measured: Until Day 2
Rilzabrutinib: unbound Cmax
Measured: Until Day 2
Rilzabrutinib: AUClast
Measured: Until Day 2
Rilzabrutinib: unbound AUC
Measured: Until Day 2
Rilzabrutinib: CL/F
Measured: Until Day 2
Rilzabrutinib: t1/2z
Measured: Until Day 2
Adverse events (AEs)
incl. Clinical laboratory evaluations, Vital signs, Electrocardiogram (ECG)
Measured: Until Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start22 Sep 2026
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853131
- Sponsor's protocol ID
- POP22852
- Other IDs
- 2026-525707-27, U1111-1333-2311
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org