CRS-Kiel
Kiel, Schleswig-Holstein, 24105, Germany
NCT Number: NCT05419635
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Kiel, Schleswig-Holstein, 24105, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants:
Participants With Hepatic Impairment:
Participants of age-, weight-, and gender-matched group :
Exclusion criteria
All participants:
Participants With Hepatic Impairment:
Participants of age-, weight-, and gender-matched group:
Study intervention BAY2433334 will be administered as tablet taken orally.
Time frame: 0 - 96 hours post dose
*AUC(0-tlast) and AUC(0 tlast)/D will be used as main parameter, respectively, if mean AUC cannot be reliably determined in all participants. In case of dose adaptation for Child Pugh B patients, AUC/D*will be evaluated instead of AUC.
Time frame: 0 - 96 hours post dose
Time frame: 0 - 96 hours post dose
In case of dose adaptation for Child Pugh B patients, Cmax/D will be evaluated instead of Cmax.
Time frame: 0 - 96 hours post dose
In case of dose adaptation for Child Pugh B patients, Cmax,u/D will be evaluated instead of Cmax,u.
Time frame: From first administration of study drug up to 4 days after end of treatment with study medication.
Bayer
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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