A Phase 1 interventional study of Asundexian (BAY2433334) in Prevention of Thromboembolic Events, Atrial Fibrillation and Acute Myocardial Infarction, sponsored by Bayer. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Bayer · Phase 1, Interventional, and Basic science
Researchers are looking for a better way to prevent the formation of blood clots in people who have or have had:
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 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:
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 27 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Participants with mildly impaired hepatic function (Child-Pugh A)
Drug: Asundexian (BAY2433334)
Participants with moderately impaired hepatic function (Child-Pugh B)
Drug: Asundexian (BAY2433334)
Participants with normal hepatic function matched to Arm A and B
Drug: Asundexian (BAY2433334)
Study intervention BAY2433334 will be administered as tablet taken orally.
Area under the concentration vs. time curve from zero to infinity after single dose (AUC)*of BAY2433334
\*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
Area under the concentration vs. time curve in plasma from zero to infinity (AUCu)* (unbound) after a single dose of BAY2433334.
\* AUC(0-tlast)u and AUC(0-tlast)u/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, AUCu/D\*, will be evaluated instead of AUCu.
Time frame: 0 - 96 hours post dose
Maximum observed drug concentration (Cmax) after single dose administration of BAY2433334.
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
Maximum observed drug concentration (Cmax,u) (unbound) after a single dose of BAY2433334.
In case of dose adaptation for Child Pugh B patients, Cmax,u/D will be evaluated instead of Cmax,u.
Time frame: 0 - 96 hours post dose
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From first administration of study drug up to 4 days after end of treatment with study medication.
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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