Obstructive sleep apnea
Conditions
Interventions
Prior to receiving the study drug on the day of dosing (Day 1), one should fast
for at least 10 hours overnight. BAY 2586116 or placebo is then given as an
intravenous infusion. The infusion lasts 3
Sponsors
Bayer AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate the pharmacokinetics (PK) of BAY 2586116 after ascending intravenous doses. Investigate the safety and tolerability of BAY 2586116 after ascending intravenous doses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed