stop_circleTerminated/Withdrawn

Chronic Kidney Disease

Study of the influence of liver function on blood concentrations of runcaciguat in participants with different degrees of liver impairment

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years

Trial summary

Enrollment Goal
5
Trial Dates
April 2021 - July 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
Runcaciguat (BAY1101042)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Kiel GmbHKiel, 24105, Germany

Primary Outcome

  • Area under the concentration vs. time curve from zero to infinity after single (first) dose (AUC) of BAY1001042
    AUC(0-tlast) will be used as main parameters if mean AUC(tlast - ∞) >20% of AUC
    date_rangeTime Frame:
    From dosing day (Day 1) up to 12 days post dose
  • Unbound AUC (AUCu) of BAY1001042
    AUC(0-tlast)u will be used as main parameters if mean AUC(tlast - ∞) >20% of AUC
    date_rangeTime Frame:
    From dosing day (Day 1) up to 12 days post dose
  • Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1001042
    date_rangeTime Frame:
    From dosing day (Day 1) up to 12 days post dose
  • Unbound Cmax (Cmax,u) of BAY1001042
    date_rangeTime Frame:
    From dosing day (Day 1) up to 12 days post dose

Secondary Outcome

  • Numbers of participants with treatment-emergent adverse events (TEAEs) and study intervention related TEAE
    date_rangeTime Frame:
    From start of treatment up to 10 days after the treatment

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3