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

NCT ID: NCT05282030

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2022-08-02

Brief Summary

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.

Detailed Description

The total duration of the study per participant will be up to 38 days including:

• A screening period of up to 4 weeks.
• A 5-day, open-label treatment period.
• Up to 7 days post-treatment follow-up period

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe Renal Impairment (RI) group (Part A only)

Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition

Group Type: EXPERIMENTAL

tolebrutinib

Intervention Type: DRUG

Pharmaceutical form: Film-coated tablets Route of administration: oral

Normal Renal Function group (Part A and B)

Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition

Group Type: EXPERIMENTAL

tolebrutinib

Intervention Type: DRUG

Pharmaceutical form: Film-coated tablets Route of administration: oral

Moderate RI group (Part B only conditional)

Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition

Group Type: EXPERIMENTAL

tolebrutinib

Intervention Type: DRUG

Pharmaceutical form: Film-coated tablets Route of administration: oral

Interventions

tolebrutinib

Pharmaceutical form: Film-coated tablets Route of administration: oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Countries

United States; Germany

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25333&tenant=MT_SNY_9011

POP16399 Plain language Results Summary

Other Identifiers

POP16399

Identifier Type: -

Identifier Source: org_study_id

U1111-1269-6877

Identifier Type: REGISTRY

Identifier Source: secondary_id

POP16399

Identifier Type: OTHER

Identifier Source: secondary_id

2021-006685-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id