Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants … (NCT05282030) | Clinical Trial Compass
CompletedPhase 1
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
United States, Germany22 participantsStarted 2022-03-10
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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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 …