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.

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. - Human Mass Balance Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50127

Enrollment

Registered

2019-12-12

Start date

2020-01-28

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood clots stroke

Interventions

BAY 2433334 will be given as an oral solution of 6.25 milliliters (mL). Immediately after administration of the study compound the participant will receive a glass with 240 mL of water, which they w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
%AE,ur and %AE,fec (and amount in vomit as a percent of the dose, if applicable) of BAY 2433334 and its metabolites based on radioactivity excreted in urine and feces as a percent of the dose to assess mass balance of total radioactivity - AUC, Cmax of total radioactivity in plasma and whole blood - AUC, Cmax of BAY 2433334 and BAY 2826102 (and metabolites, if applicable) in plasma	—

Secondary

Measure	Time frame
Frequency of participants with treatment emergent adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)