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

NCT04820621 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-07-15

No results posted yet for this study

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

Interventions

DRUG

Runcaciguat (BAY1101042)

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04820621 on ClinicalTrials.gov