To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
A single oral dose of 0.5 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions
BlueClinical Phase 1 Hospital de Prelado
Porto, Portugal
Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod
Time frame: Total duration: up to 52 days
Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod
Time frame: Total duration: up to 52 days
The maximum plasma concentration (Cmax) of cenerimod
Time frame: Total duration: up to 52 days
The time to reach Cmax (tmax) of cenerimod
Time frame: Total duration: up to 52 days
Terminal half-life (t½) of cenerimod
Time frame: Total duration: up to 52 days
Apparent oral clearance (CL/F) of cenerimod
Time frame: Total duration: up to 52 days
Extent of cenerimod protein plasma binding (PPB)
Time frame: Total duration: up to 52 days
Apparent volume of distribution (Vz/F) of cenerimod
Time frame: Total duration: up to 52 days
Total lymphocyte count count.
Time frame: Total duration: up to 66 days
Change from baseline at each time point of measurement in electrocardiogram QT interval
Time frame: Total duration: up to 66 days
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Change from baseline in body weight
Time frame: Total duration: up to 66 days
Change from baseline in systolic and diastolic blood pressure (in the supine position)
Time frame: Total duration: up to 66 days
Incidence of abnormal laboratory test results
Time frame: Total duration: up to 66 days