The aim of this study in subjects with obstructive sleep apnea is to investigate pharmacodynamics, safety and tolerability after a single nasal administration of BAY2253651 and to evaluate first safety and tolerability of multiple dosing over 5 consecutive nights in OSA patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
100 µg (500 µg/ml \* 200 µl) BAY2253651 intranasally
Matching Placebo dosing
University Hospital Zürich
Zurich, Switzerland
Oxford University Hospitals
Oxford, United Kingdom
Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50%
Time frame: 2 days
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to 7 days
Severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 7 days
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