Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of tolebrutinib tablets compared with normal renal function, in male and female participants aged 18 to 79 years.

Key facts

Study ID: NCT05282030
Run by: Sanofi
People needed: 22
Starts: 2022-03-10
Expected to finish: 2022-08-02
Last updated by the study team: 2025-02-06

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For participants with severe RI (Part A): Absolute GFR <30 mL/min, and not requiring dialysis (based on estimated glomerular filtration rate [eGFR] by absolute GFR from the MDRD formula with individual BSA, without race correction), with a variability within +/- 20% between screening and Day -1 assessments.
For participants with moderate RI (Part B conditional): 30 mL/min ≤ absolute GFR ≤59 mL/min (based on estimated glomerular filtration rate [eGFR] by absolute GFR from the MDRD formula with individual body surface area (BSA), without race correction), with a variability within +/- 20% between screening and Day -1 assessments
For participants with normal renal function: Absolute GFR ≥ 90 mL/min (based on eGFR by absolute GFR from the MDRD formula with individual BSA, without race correction), with a variability within +/- 20% between screening and Day -1 assessments.
For all participants:
Body weight between 50.0- and 115.0 kg, inclusive, if male, between 40.0 and 100 kg, inclusive, if female, and body mass index (BMI) between 18 to 40 kg/m2 inclusive, at screening.
Participant with platelet count ≥150 000/μL at the screening visit and at Day -1

You may not qualify if…

For all participants:
Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension, defined as a decrease in SBP≥30 mmHg within 3 minutes when changing from a supine to a standing position at screening and Day -1
Blood donation (usually approximately 500 mL), within 2 months before inclusion.
Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
History of alcohol or drug abuse within 1 year prior to screening
Smoking regularly more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 8 cigarettes per day during the institutionalization.
Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion
Use of any herbal medicines 2 weeks before IMP administration
Treatment with a strong, moderate or mild CYP2C8 inducer or inhibitor, OR a strong, moderate or mild CYP3A inducer, OR a strong, or moderate CYP3A inhibitor, within 14 days before the study treatment administration or 5 half-lives, whichever is longer
Specific criteria for participants with RI
Active liver disease, cirrhosis, chronic liver disease, hepatic insufficiency
Acute renal failure (de novo or superimposed to preexisting chronic RI), nephrotic syndrome.
History of or current hematuria of urologic origin that limits the participant's participation in the study
Participant requiring dialysis during the study
Specific criteria for participants with normal renal function:
Any history or presence of clinically relevant hepatic or renal disease
NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Where it is running

Clinical Pharmacology of Miami Site Number : 8400002 — Miami, Florida, United States
Nucleus Network Site Number : 8400001 — Saint Paul, Minnesota, United States
Volunteer Research Group-NOCCR Site Number : 8400003 — Knoxville, Tennessee, United States
Investigational Site Number : 2760001 — Kiel, Germany

Full record on ClinicalTrials.gov

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