Single dose escalation study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 2413555 after oral dosing in healthy male participants in a randomized, single-blind, placebo-controlled, group-comparison desig
- Conditions
- Heart Failure10019280
- Registration Number
- NL-OMON54965
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
- Healthy male participants
- Age: 18 to 50 years of age (inclusive), at the time of signing the informed
consent
- Race: White
- Body mass index (BMI) within the range of 18-29.9 kg/m2 (inclusive) at the
time of screening.
- The informed consent must be signed before any study specific tests or
procedures are done
1. Medical disorder, condition or history of such that would impair the
participant*s ability to take part in or complete this study in the opinion of
the investigator
2. A history of relevant or ongoing diseases such as:
- respiratory tract: e.g. asthma, any airway obstruction
- central nervous system: e.g. seizures, cerebrovascular malformations (e.g.
aneurysm), psychiatric or neurological disorders
- gastrointestinal tract: e.g. gallstones, any obstruction of the intestinum/
intestinal glands (e.g. pancreas), peptic ulcer
- urinary tract: e.g. nephrolithiasis, any obstruction of the urinary passage
3. Any condition for which it can be assumed that the absorption, distribution,
metabolism, elimination and effects of the study intervention(s) will not be
normal
4. Known hypersensitivity to any study intervention (active substances or
excipients of the preparations) to be used in the study - including e.g.
non-investigational medicinal products, challenge agents, or rescue medication
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.
For the complete overview, see the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Investigate the safety and tolerability of BAY 2413555 after single oral<br /><br>dosing in healthy participants (Number and percentage of participants with<br /><br>TEAEs)<br /><br>- Investigate the pharmacokinetics of BAY 2413555 (Cmax, AUC, Cmax/D, AUC/D of<br /><br>BAY 2413555 (if AUC cannot be determined reliably in all participants,<br /><br>AUC(0-tlast) will be used instead))</p><br>
- Secondary Outcome Measures
Name Time Method <p>Investigate the pharmacodynamics of BAY 2413555 (Heart rate over 1 min over<br /><br>time (0-6 hours, adjusted for pre-dosing day and placebo)</p><br>