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A Study to Learn About the Taste of Vericiguat Given in Liquid Form in Healthy Male Participants Aged 18 to 45 Years

NCT06474208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-10-08

No results posted yet for this study

Summary

Heart failure is a condition in which the heart does not pump blood as well as it should. It can happen in both adults and children. The study treatment, vericiguat, also called BAY1021189, is already approved for doctors to give to adults who have heart failure, particularly those with an ejection fraction (EF) reduced to less than 45%. An EF is a measurement, expressed as a percentage, of how much blood is pumped with each heartbeat. An EF of less than 45% indicates a reduced ability of the heart to pump blood effectively. This results in a reduced supply of the oxygen that the body requires to function properly.

Vericiguat works by increasing the activity of a protein called soluble guanylate cyclase (sGC). sGC helps widen blood vessels, which in turn improves the heart function. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure and it will be easier for them to take a liquid treatment.

The main purpose of this study is to find out how the taste of the liquid form of vericiguat for children changes when different amounts of flavor improvers are added.

During the study, participants will take 5 different study drugs in different orders. They will take:

* Vericiguat: 4 different formulations of vericiguat which are flavored differently.
* Placebo: A placebo that looks like vericiguat but does not have any medicine in it.

Participants will taste these formulations or placebo but will not swallow them.

During the study, the doctors and their study team will:

* check participants' health by performing tests such as blood and urine tests.
* measure vital signs, including blood pressure and heart rate.
* check heart health using an electrocardiogram (ECG). An ECG is a test that records the electrical activity of the heart.
* ask the participants open questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Conditions

Interventions

DRUG

Formulation 1

Oral suspension of Vericiguat (BAY1021189) in single dose (SD).

DRUG

Formulation 2

Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose in SD.

DRUG

Formulation 3

Oral suspension of Vericiguat (BAY1021189) with increased level of flavor in SD.

DRUG

Formulation 4

Oral suspension of Vericiguat (BAY1021189) with increased level of sucralose and flavor in SD.

DRUG

Formulation 5 (placebo)

Matching placebo of formulation 1 in SD.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-09-30
Completion
2024-09-30

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 NCT06474208 on ClinicalTrials.gov