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

Part of paid clinical trials in Miami, Florida.

Sponsor
Sanofi
Study ID
NCT05282030
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • tolebrutinib — DRUG
    Pharmaceutical form: Film-coated tablets Route of administration: oral

Study Details

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 Dates

Start date
Mar 10, 2022
Status verified
Feb 2025
Primary completion
Aug 2, 2022
Completion
Aug 2, 2022

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Severe Renal Impairment (RI) group (Part A only)
    Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
  • Experimental: Normal Renal Function group (Part A and B)
    Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
  • Experimental: Moderate RI group (Part B only conditional)
    Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition

Primary Outcome Measure

Assessment of PK parameters Tolebrutinib: AUC [ Time Frame: From Day 1 to Day 4 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami Site Number : 8400002MiamiFlorida33014-
Nucleus Network Site Number : 8400001Saint PaulMinnesota55114-
Volunteer Research Group-NOCCR Site Number : 8400003KnoxvilleTennessee37920-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology of Miami· Miami, FLNucleus Network· Saint Paul, MNVolunteer Research Group-NOCCR· Knoxville, TN

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