NL-OMON54965
Completed
Not Applicable
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 design - A safety, absorption, elimination & activity study of BAY2413555
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bayer AG
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Healthy male participants
- •\- Age: 18 to 50 years of age (inclusive), at the time of signing the informed
- •\- 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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