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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Pharmaceutical form: Film-coated tablets Route of administration: oral
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
Assessment of PK parameters Tolebrutinib: AUC
Area under the plasma concentration (AUC) versus time curve extrapolated to infinity
Time frame: From Day 1 to Day 4
Assessment of PK parameters M2: AUC
Time frame: From Day 1 to Day 4
Assessment of PK parameters Tolebrutinib: Cmax
Maximum plasma concentration observed (Cmax)
Time frame: From Day 1 to Day 4
Assessment of PK parameters M2: Cmax
Time frame: From Day 1 to Day 4
Assessment of PK parameters Tolebrutinib: AUClast
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time AUClast
Time frame: From Day 1 to Day 4
Assessment of PK parameters M2: AUClast
Time frame: From Day 1 to Day 4
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From Day 1 to Day 8
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