This is a prospective, open-label, single-dose, phase 1 study, to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics of cenerimod (ACT-334441).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
A single oral dose of 0.5 mg.
CRU Hungary
Kistarcsa, Hungary
BlueClinical Phase 1 Hospital de Prelado
Porto, Portugal
Area under the plasma concentration-time curves (AUC0-t): cenerimod
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Area under the plasma concentration-time curve from zero to infinity (AUC0-inf): cenerimod
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Maximum plasma concentration (Cmax): cenerimod.
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Time to reach Cmax (tmax): cenerimod
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Terminal half-life (t½): cenerimod
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Plasma protein binding of cenerimod
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Apparent clearance (CL/F) of cenerimod
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Apparent volume of distribution (Vz/F) of cenerimod
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Total lymphocyte count
Time frame: Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 98.
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Change from baseline at each time point of measurement in electrocardiogram QT interval
Time frame: Pre-defined times on Day 1 (pre-dose) up to Day 105.
Change from baseline in body weight
Time frame: Day -1 and Day 105.
Change from baseline in systolic and diastolic blood pressure (in the supine position)
Time frame: Predefined times on Day 1 (pre-dose) up to Day 105.
Incidence of abnormal laboratory test results
Time frame: Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 105.
Adverse events and serious adverse events
Time frame: Day 1 up to Day 105.