This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild and moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of selatogrel (ACT-246475).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
A single subcutaneous injection of 16 mg.
CRS Clinical Research Services
Kiel, Germany
The maximum plasma concentration (Cmax) of selatogrel
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.
Time to reach Cmax (tmax)
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.
Area under the plasma concentration-time curves (AUC0-t) of selatogrel
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.
The area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of selatogrel
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.
Terminal half-life (t½) of selatogrel
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.
The apparent clearance (CL/F) of selatogrel
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.
The apparent volume of distribution (Vz/F) of selatogrel
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3.
Plasma protein binding of selatogrel
Time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose and post-dose).
Change from baseline in supine blood pressure
Time frame: Multiple predefined times on Day 1 (pre-dose) up to Day 3.
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Change from baseline in temperature
Time frame: Multiple predefined times on Day 1 (pre-dose) up to Day 3.
Change from baseline in pulse rate
Time frame: Multiple predefined times on Day 1 (pre-dose) up to Day 3.
Change from baseline in body weight
Time frame: Multiple predefined times on Day 1 (pre-dose) up to Day 3.
Change from baseline in clinical laboratory tests
Time frame: Multiple predefined times on Day 1 (pre-dose) up to Day 3.
Change from baseline at each time point of measurement in ECG variables.
Time frame: Multiple predefined times on Day 1 (pre-dose) up to Day 3.
Inhibition of platelet aggregation
Time frame: Multiple predefined times on Day 1 (pre-dose) up to Day 3.