The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics

Inclusion Criteria

• •All participants (Groups 1,2 and 3)
• •Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
• •Male or female participant aged between 18 and 79 years (inclusive) at screening.
• •Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
• •Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 (pre-dose). They must consistently and correctly use (from screening, during the entire study, and for at least 30 days after last study treatment administration) an acceptable effective method of contraception method, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must have been initiated at least 1 month before treatment administration.
• •Women of non-childbearing potential.
• •Hepatic impairment due to liver cirrhosis according to the Child-Pugh classification:
• •* Group 1: Mild hepatic impairment, Child-Pugh A = score 5-6.
• •* Group 2: Moderate hepatic impairment, Child-Pugh B = score 7-9.
• •Systolic blood pressure (SBP) 95-160 mmHg, diastolic blood pressure (DBP) 60-95 mmHg, and pulse rate 50-100 bpm (inclusive), measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 (pre-dose).
• •Estimated glomerular filtration rate (eGFR) at screening using the Modification of Diet in Renal Disease (MDRD) formula of:
• •* greater than or equal to 60 mL/min/1.73 m2 for participants with mild hepatic impairment (Group 1)
• •* greater than or equal to 45 mL/min/1.73 m2 for participants with moderate hepatic impairment (Group 2).
• •Stable concomitant medications for at least 3 weeks prior to screening and up to Day 1 and expected to be stable during the conduct of the study.
• •Normal blood pressure measured on the same arm, after 5 minutes in the supine position at screening and on Day 1 pre-dose defined as:
• •* SBP 90 to 140 mmHg, DBP 60 to 90 mmHg, and pulse rate 50 to 100 bpm (inclusive) for participants less than 60 years of age.
• •* SBP 95 to 160 mmHg, DBP 65 to 95 mmHg, and pulse rate 50 to 100 bpm (inclusive) for participants 60 years and older.
• •eGFR greater than or equal to 80 mL/min/1.73 m2 at screening using the MDRD formula.