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

NCT04820621 | Terminated Phase 1

• 2 other identifiers: 196202020-005716-22
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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 Outcomes (1)

• 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

Study Arms (3)

Participants with mild hepatic impairment

EXPERIMENTAL

All participants will receive a single oral dose in the fasted state on Day 1.

Drug: Runcaciguat (BAY1101042)

Participants with moderate hepatic impairment

EXPERIMENTAL

All participants will receive a single oral dose in the fasted state on Day 1.

Drug: Runcaciguat (BAY1101042)

Participants with normal hepatic function

EXPERIMENTAL

All participants will receive a single oral dose in the fasted state on Day 1.

Drug: Runcaciguat (BAY1101042)

Interventions

Runcaciguat (BAY1101042) DRUG

Given as 1 x 15 mg modified release \[MR\] tablet

Participants with mild hepatic impairment; Participants with moderate hepatic impairment; Participants with normal hepatic function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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.
• 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.
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical-Research-Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

BAY 1101042

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: April 7, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)