NCT04820621

Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Runcaciguat (BAY1101042)	Given as 1 x 15 mg modified release \[MR\] tablet

Timeline

• Start date: 2021-04-07
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2021-03-29
• Last updated: 2021-07-15

Locations

1 site across 1 country: Germany