Chronic Kidney Disease
Conditions
Brief summary
Researchers are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the drug in the body. In this study researchers will investigate how the liver function influences blood concentrations of runcaciguat in participants with different degrees of liver impairment compared to participants with normal liver function. The participants will all take one tablet with 15 mg runcaciguat by mouth. Prior to inclusion into the study, all participants will have a screening examination within 21 to 2 days prior to dosing to check eligibility for study participation. During the study, all of the participants will stay at the study site for up to 8 days (from Day -1 to Day 7), whereby Day 6 and 7 might also be performed in an ambulatory setting. Blood and urine samples will be collected. The physician will check the participants' heart health using an electrocardiogram (ECG) and by measuring blood pressure and heart rate. The participants will answer questions about their wellbeing and taken medications. The participants will have a follow-up examination 7 to 11 days after dosing to follow-up their health. Each participant will be in the study for approximately 5 weeks. The entire study will last about 9 months.
Interventions
Given as 1 x 15 mg modified release \[MR\] tablet
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
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 * Male and female white participants. Main Inclusion Criteria for participants with hepatic impairment * Participants with hepatic impairment (Child Pugh A or B). * Participants with stable liver disease in the last 2 months. Main Inclusion Criteria for control group of participants * 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.
Exclusion criteria
Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042 | From dosing day (Day 1) up to 12 days post dose | AUC(0-tlast) will be used as main parameters if mean AUC(tlast - ∞) \>20% of AUC |
| Unbound AUC (AUCu) of BAY1001042 | From dosing day (Day 1) up to 12 days post dose | AUC(0-tlast)u will be used as main parameters if mean AUC(tlast - ∞) \>20% of AUC |
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1001042 | From dosing day (Day 1) up to 12 days post dose | — |
| Unbound Cmax (Cmax,u) of BAY1001042 | From dosing day (Day 1) up to 12 days post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Numbers of participants with treatment-emergent adverse events (TEAEs) and study intervention related TEAE | From start of treatment up to 10 days after the treatment |
Countries
Germany
Outcome results
None listed