Investigation of the Pharmacokinetics, Safety and Tolerability of Runcaciguat in Participants With Hepatic Impairment (Classified as Child Pugh A or B) and in a Control Group of Age-, Weight-, and Gender-matched Participants Following a Single Oral 15 mg Modified Release (MR) Tablet Dose in a Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
Overview
- Phase
- Phase 1
- Intervention
- Runcaciguat (BAY1101042)
- Conditions
- Chronic Kidney Disease
- Sponsor
- Bayer
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant must be 18 to 79 years of age (inclusive) at the time of signing the informed consent.
- •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 exclusion Criteria for all participants Medical and surgical history
- •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.
- •coronavirus disease 2019 (COVID-19) specific exclusion criteria
- •History of COVID-
- •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
Arms & Interventions
Participants with mild hepatic impairment
All participants will receive a single oral dose in the fasted state on Day 1.
Intervention: Runcaciguat (BAY1101042)
Participants with moderate hepatic impairment
All participants will receive a single oral dose in the fasted state on Day 1.
Intervention: Runcaciguat (BAY1101042)
Participants with normal hepatic function
All participants will receive a single oral dose in the fasted state on Day 1.
Intervention: Runcaciguat (BAY1101042)
Outcomes
Primary Outcomes
Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042
Time Frame: 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 Cmax (Cmax,u) of BAY1001042
Time Frame: From dosing day (Day 1) up to 12 days post dose
Unbound AUC (AUCu) of BAY1001042
Time Frame: 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
Time Frame: From dosing day (Day 1) up to 12 days post dose
Secondary Outcomes
- 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)