Single center, open-label, non-randomized, non-placebo-controlled study to investigate the pharmacokinetics, metabolic disposition and mass balance after single administration of 25 mg [14C]BAY 2433334 (oral solution) in healthy male participants.

Completed

• Conditions: blood clots; stroke; 10082206; 10047066

• Registration Number: NL-OMON50127
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Healthy white male
Between 18 and 55 years of age.
BMI is between 18 and 29.9 kilograms/meter2

Exclusion Criteria

1. A history of relevant diseases of vital organs, of the central nervous
system or other organs.
2. Medical disorder, condition or history of such that would impair the
participant's ability to participate or complete this study in the opinion of
the investigator.
3. Incompletely cured pre-existing diseases for which it can be assumed that
the absorption, distribution, metabolism, elimination and effects of the study
intervention will not be normal.
4. Known hypersensitivity to the study interventions (active substance or
excipients of the preparation).
5. Known severe allergies e.g. allergies to more than 3 allergens, allergies
affecting the lower respiratory tract - allergic asthma, allergies requiring
therapy with corticosteroids, urticaria or significant non-allergic drug
reactions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> %AE,ur and %AE,fec (and amount in vomit as a percent of the dose, if<br /><br>applicable) of BAY 2433334 and its metabolites based on radioactivity excreted<br /><br>in urine and feces as a percent of the dose to assess mass balance of total<br /><br>radioactivity<br /><br>- AUC*, Cmax of total radioactivity in plasma and whole blood<br /><br>- AUC*, Cmax of BAY 2433334 and BAY 2826102 (and metabolites, if applicable) in<br /><br>plasma</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Frequency of participants with treatment emergent adverse events</p><br>