Single dose escalation study in a single-center, randomized, single-blind, placebo-controlled, group-comparison design to investigate pharmacokinetics, safety and tolerability of BAY 2586116 after intravenous administration in healthy male participants.
- Conditions
- Obstructive sleep apnea10046304
- Registration Number
- NL-OMON49427
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Participant must be 18 to 45 years of age inclusive, at the time of signing the
informed consent.
Participants who are overtly healthy as determined by medical evaluation
(including medical and surgical history, physical examination,laboratory tests,
ECG, vital signs, and pulse oximetry). Re-screening may be allowed.
Race: White (Note: Clinical Data Interchange Standards Consortium definition of
White: Denotes a person with European, Middle Eastern, or North African
ancestral origin who identifies, or is identified, as White (Food and Drug
Administration).
Male participant.
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
A history of relevant diseases of vital organs, of the central nervous system
or other organs
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.
Regular use of medicines.
Positive SARS-CoV-2 viral RNA test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Investigate the pharmacokinetics (PK) of BAY 2586116 after ascending<br /><br>intravenous doses.<br /><br>Investigate the safety and tolerability of BAY 2586116 after ascending<br /><br>intravenous doses.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>