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A Study in Healthy Adult Male Participants to Learn the Way Vericiguat is Absorbed With and Without Food When Taken as a Single Dose in Liquid Form Suitable for Children Compared to a 10 Milligram (mg) Tablet That Releases the Active Substance Immediately

NCT05086952 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-02

No results posted yet for this study

Summary

Researchers are looking for a better way to treat heart failure, a condition in which the heart does not pump blood as well as it should. Heart failure can happen in both adults and children.

The study treatment, vericiguat, is already available for doctors to give to adults who have heart failure. It works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation.

The current form of vericiguat is a tablet that releases the "active substance" immediately. The "active substance" is the part of the drug that works in the body to treat the condition. Vericiguat is currently only available as a treatment for adults. Researchers think vericiguat could help treat children with heart failure, but think it will be easiest for them to take a liquid treatment.

Another study is planned to find out how well vericiguat works in children who have a specific type of heart failure. Before researchers can give vericiguat to children, they must first study different doses and ways of taking vericiguat in adults. In this study, the researchers will study a new liquid form of vericiguat in adults. This form is also known as the "pediatric formulation".

In this study, the researchers want to find out how the new pediatric formulation of vericiguat moves into, through, and out of the body compared to the currently approved tablet form for adults. The researchers also want to find out if eating food affects the new pediatric formulation differently than the current tablet form of vericiguat.

The study will include about 36 healthy white male participants aged between 18 and 45 years old.

During this study, the participants will all take 4 different treatments in different orders. They will take:

* a high dose of vericiguat in the new pediatric formulation, with food
* a high dose of vericiguat in the new pediatric formulation, without food
* a low dose of vericiguat in the new pediatric formulation, with food
* a dose of the currently available tablet form, with food While taking each study treatment, the participants will stay at the study site for 4 days. There will be a break of at least 10 days between each treatment. Overall, the participants will be in this study for about 11 weeks.

During the study, the participants will:

* have blood and urine samples taken
* have their overall health and heart health checked
* answer questions about how the new pediatric formulation tastes
* answer questions about any 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 that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Conditions

Interventions

DRUG

Vericiguat (BAY1021189) - Intervention A

Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fed state.

DRUG

Vericiguat (BAY1021189) - Intervention B

Single dose of 10 mg vericiguat high-concentration pediatric formulation (oral liquid formulation) in fasted state.

DRUG

Vericiguat (BAY1021189) - Intervention C

Single dose of 2.5 mg vericiguat low-concentration pediatric formulation (oral liquid formulation) in fed state.

DRUG

Vericiguat (Verquvo, BAY1021189) - Intervention D

Single dose of 10 mg vericiguat immediate release (IR) intact tablet in fed state.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2021-12-22
Completion
2022-02-15

Countries

  • Germany

Study Locations

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Diseases
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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 NCT05086952 on ClinicalTrials.gov