coronary artery disease
Conditions
Interventions
On day 1, the volunteers are administered 25 mg of BAY 2433334 followed 2 hours
later by 50 µg of 13C7.15N-labeled BAY 2433334.
Sponsors
Bayer AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • healthy white male • 18 to 45 years old at the time of the screening visit • BMI is between 18 and 29.9 kilograms/meter2 • not regularly drink more than 17.5 units of alcohol per week. 17.5 units of alcohol is equal to approximately 12 glasses (285 mL) of beer or lager, 12 glasses (125 mL) of wine, or 17 small shots (25 mL) of spirits. • do not regularly consume more than 1 L of methylxanthine or caffeine-containing beverages daily. • did not donate more than 100 mL of blood or plasma within 4 weeks or 500 mL blood within 3 months before study compound administration. Blood donation is not allowed during the entire study, until 3 months after the last visit. • not participated in any other drug study within 3 months preceding the administration of the study compound. • no history of COVID-19 infection, do not test positive in the SARS-CoV-2 test, and no contact with SARS-CoV-2-positive or COVID-19 patients within 4 weeks prior to admission to the research center. • at screening the state of health must satisfy the study entry requirements.
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 |
|---|---|
| To investigate the absolute bioavailability and pharmacokinetics of BAY 2433334 using a simultaneous oral unlabeled and i.v. [13C7,15N]-labeled microdose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate safety and tolerability of BAY 2433334. | — |
Countries
Netherlands
Outcome results
None listed