Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT05419635
Status:
COMPLETED
Last Update Posted:
2023-08-29
First Post:
2022-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn How the Study Treatment Asundexian Moves Into, Through and Out of the Body, How it Works, How Safe it is, and How it Affects the Body in Participants With Mild or Moderate Reduction of Liver Function Compared to Participants With Normal Liver Function
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Investigation of the Influence of Hepatic Impairment on Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Asundexian in Participants With Mild or Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function.
Status:
COMPLETED
Status Verified Date:
2023-08
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:
Researchers are looking for a better way to prevent the formation of blood clots in people who have or have had:
* an irregular and often rapid heartbeat
* a blocked blood flow to the heart
* a blocked or reduced blood flow to a part of the brain. When a blood clot forms in the body in patients with the above conditions, it may block vessels of the heart, the brain and/or other parts of the body. This may lead to heart attack, stroke and other serious complications.
Blood clots are formed in a process known as coagulation. This is a complex series of steps that must occur in a specific sequence. Medications are already available to prevent the formation of blood clots. They work by interrupting one or more of the coagulation steps and are therefore known as anticoagulants. They decrease the risk of the above-mentioned complications.
The study treatment asundexian works by blocking a very specific step in the blood clotting process, the activation of a protein called Factor XIa. Due to its very specific action that is not thought to be involved in the main blood clotting steps needed to stop bleeding (e.g. like from a cut finger), asundexian is expected to reduce the risk of bleeding that is still seen with existing anticoagulants. Since people who need an anticoagulant may also have liver problems, information on asundexian use in this group is needed.
The main purpose of this study is to learn how asundexian moves into, through and out of the body in participants with a mild or moderate reduction in liver function compared to participants with normal liver function who are similar in age, weight, and gender.
To answer this question, researchers will measure
* the average highest level of asundexian in the blood (also referred to as Cmax)
* the average total level of asundexian in the blood (also referred to as AUC). that were reached after intake of a single tablet of asundexian.
The researchers will compare these data between participants with reduced liver function and matched participants with normal liver function to look for differences.
Each participant will be in the study for up to 4 weeks. Participants will stay in-house for 6 days, starting the day before taking asundexian. In addition, two visits to the study site are planned.
During the study, the doctors and their study team will:
* do physical examinations
* check vital signs
* take blood and urine samples
* examine heart health using an electrocardiogram (ECG)
* ask the participants 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 that happen in studies, even if they do not think the adverse events might be related to the study treatments.
* an irregular and often rapid heartbeat
* a blocked blood flow to the heart
* a blocked or reduced blood flow to a part of the brain. When a blood clot forms in the body in patients with the above conditions, it may block vessels of the heart, the brain and/or other parts of the body. This may lead to heart attack, stroke and other serious complications.
Blood clots are formed in a process known as coagulation. This is a complex series of steps that must occur in a specific sequence. Medications are already available to prevent the formation of blood clots. They work by interrupting one or more of the coagulation steps and are therefore known as anticoagulants. They decrease the risk of the above-mentioned complications.
The study treatment asundexian works by blocking a very specific step in the blood clotting process, the activation of a protein called Factor XIa. Due to its very specific action that is not thought to be involved in the main blood clotting steps needed to stop bleeding (e.g. like from a cut finger), asundexian is expected to reduce the risk of bleeding that is still seen with existing anticoagulants. Since people who need an anticoagulant may also have liver problems, information on asundexian use in this group is needed.
The main purpose of this study is to learn how asundexian moves into, through and out of the body in participants with a mild or moderate reduction in liver function compared to participants with normal liver function who are similar in age, weight, and gender.
To answer this question, researchers will measure
* the average highest level of asundexian in the blood (also referred to as Cmax)
* the average total level of asundexian in the blood (also referred to as AUC). that were reached after intake of a single tablet of asundexian.
The researchers will compare these data between participants with reduced liver function and matched participants with normal liver function to look for differences.
Each participant will be in the study for up to 4 weeks. Participants will stay in-house for 6 days, starting the day before taking asundexian. In addition, two visits to the study site are planned.
During the study, the doctors and their study team will:
* do physical examinations
* check vital signs
* take blood and urine samples
* examine heart health using an electrocardiogram (ECG)
* ask the participants 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 that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-000196-38 | EUDRACT_NUMBER | None | View |