Clareo Health | Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment
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Keep this study
Lead
Bayer
Age
18–79
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Age
Participant must be 18 to 79 years of age (inclusive) at the time of signing the informed consent.
Weight
Body mass index (BMI) within the range 18 to 35 kg/m\^2 (inclusive). Sex and Contraceptive/Barrier Requirements
Participants with hepatic impairment (Child Pugh A or B).
Healthy male and female white participants.
Mean age and body weight in the control group and in the two groups with hepatic impairment (Child Pugh A and B) should not vary by more than ±10 years and ±10 kg.
Gender-matched.
You may not be if
Participants with a medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the sponsor.
Medication, drug use and special behavioral patterns
Suspicion of drug or alcohol abuse. Other
Participation in another clinical trial within 3 months (for previous multi-dose study) or 1 month (for previous single dose study) before dosing.
Exclusion periods from other studies or simultaneous participation in other clinical studies.
History of COVID-19.
Contact with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) positive or COVID-19 patient within the last 4 weeks prior to admission to the clinical unit
Positive SARS-CoV-2 viral polymerase chain reaction (PCR) test
Pre-existing diseases beside hepatic impairment for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
Evidence of hepatic encephalopathy related to chronic liver disease \> grade 2 (exclusion by Number Connection Test).
Congestive heart failure of New York Heart Association grade III or IV.
History of conspicuous bleeding within the past 3 months.
Severe arrhythmia requiring antiarrhythmic treatment within the past 3 months.
Participants with diabetes mellitus with a glycohemoglobin A1c (HbA1c) \>9%.
Severe ascites of more than 6 L (estimated by ultrasound).
Participants with primary and secondary biliary cirrhosis.
Participants with sclerosing cholangitis. Electrocardiogramm (ECG), blood pressure, heart rate
Systolic blood pressure below 100 mmHg or above 169 mmHg.
Diastolic blood pressure below 50 and above 95 mmHg.
Resting heart rate below 50 beats per minute (bpm) or above 95 bpm. Laboratory examination
Platelet count \< 40 x 10\^9/L.
Hemoglobin \<9 g/dL.
Alkaline phosphatase (AP) ≥ 4 times the upper limit of normal (ULN).
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) in conjunction with gamma glutamyl transpeptidase (GGT) ≥4 times the ULN (an isolated elevation of GGT above 4 times ULN will not exclude the participant).
Serum albumin \<20 g/L.
Prothrombin time (Quick test) \<40%.
Renal failure with an estimated glomerular filtration rate (eGFR) ≤ 40 mL/min/1.73 m\^2 (according to CKD-EPI equation).
A history of relevant diseases of vital organs, the central nervous system, or other organs.
Liver insufficiency or active liver disease, which may include unexplained persistent transaminase elevations.
Renal impairment with an estimated glomerular filtration rate (eGFR) ≤80 mL/min/1.73 m\^2 (according to CKD-EPI equation).
Known or suspected liver disorders (e.g. Morbus Gilbert/Meulengracht) and bile secretion/flow (cholestasis, also history of it).
Medication, drug use and special behavioral patterns
Regular use of therapeutic or recreational drugs, e.g. carnitin products, anabolics, high dose vitamins.
Laboratory examination
Relevant deviation from the normal range in clinical chemistry (including thyroid stimulating hormone \[TSH\]), hematology, coagulation or urinalysis as judged by the investigator.
Increase of liver enzymes (e.g. ALT, AST, alkaline phosphatase, gamma glutamyl transpeptidase or total bilirubin) above ULN.
Increase of lipase and amylase (despite isolated marginal increases of lipase or amylase to account for variability of the parameters, and the participant is asymptomatic and has no other laboratory changes assuming disease based on medical judgment).
Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus (HIV) antibodies 1+2/HIV p24 antigen (HIV-1/2 combi test).
