on-blinded, non-randomized study to investigate the pharmacokinetics, including absolute bioavailability of BAY 2433334 following administration of a 25 mg oral dose and a 50 µg intravenous [13C7,15N]-labeled BAY 2433334 microdose in healthy male participants

Completed

• Conditions: 10014523; coronary artery disease

• Registration Number: NL-OMON49790
• 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: 16

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

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>To investigate the absolute bioavailability and pharmacokinetics of BAY 2433334<br /><br>using a simultaneous oral unlabeled and i.v. [13C7,15N]-labeled microdose.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate safety and tolerability of BAY 2433334.</p><br>