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A Study to Learn How the Study Treatment BAY1753011 Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body When Given Once as Tablet in Male and Female Participants With Reduced Kidney Function Compared to Matched Participants With Normal Kidney Function

NCT05599997 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-10-31

No results posted yet for this study

Summary

Researchers are looking for a better way to treat people with heart failure. Heart failure is a condition which occurs when the heart does not pump blood as well as it should leading to shortness of breath, tiredness, and ankle swelling.

The study treatment BAY1753011 is under development to treat heart failure. It is thought to reduce the action of a hormone called vasopressin that is naturally produced in the body. People with heart failure often have elevated levels of vasopressin. This is known to result in worsening of the heart failure condition.

People with heart failure often also have reduced kidney functions. As kidneys play a role in removal of drugs from the body, reduced kidney function may result in higher blood levels of BAY1753011.

The main purpose of this study was to learn how BAY1753011 moved into, through and out of the body in participants with different degrees of reduced kidney function compared to matched participants (age, gender, and weight) with normal kidney function.

To answer this, the researchers compared:

* the (average) total level of BAY1753011 in the blood (also called AUC)
* the (average) highest level of BAY1753011 in the blood (also called Cmax) between the different groups with reduced kidney function (mild/moderate/severe) and the control group (normal kidney function).

In addition, the researchers wanted to know how safe BAY1753011 was and the degree to which overt medical problems caused by it could be tolerated (also called tolerability) by the different groups of participants.

These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.

All participants took a single dose of BAY1753011 in tablet form by mouth. Each participant was in the study for approximately 3 to 4 weeks, including an in-house phase of 5 days and 4 nights with one treatment day.

During the study, the doctors and their study team:

* did physical examinations
* checked vital signs such as blood pressure, heart rate, body temperature and number of breaths within a minute (respiratory rate)
* examined heart health using electrocardiogram (ECG)
* took blood and urine samples
* counted the number of toilet visits during the night

Conditions

  • Congestive Heart Failure
  • Renal Impairment

Interventions

DRUG

Pecavaptan (BAY1753011)

30 mg, immediate release tablet, single dose, oral

DRUG

Pecavaptan (BAY1753011)

15 mg, immediate release tablet, single dose, oral

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2021-01-22
Completion
2021-05-18

Countries

  • Germany

Study Locations

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Entities

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 NCT05599997 on ClinicalTrials.gov