Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474208
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-06-20
Brief Title:
A Study to Learn About the Taste of Vericiguat Given in Liquid Form in Healthy Male Participants Aged 18 to 45 Years
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase 1 Single-blind Randomized 5-fold Crossover Taste Panel Study to Investigate the Taste Profile of an Oral Suspension of BAY 1021189 Vericiguat in Healthy Male Participants 18 to 45 Years of Age
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508447-52-00 | REGISTRY | None | None |