Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

February 4, 2020

Primary Completion Date

May 6, 2021

Study Completion Date

June 24, 2021

Conditions
Sleep Apnea, Obstructive
Interventions
DRUG

BAY2586116 (A1)

160 μg BAY2586116 (nasal spray administration)

DRUG

Placebo (A2)

Placebo matching BAY2586116 (nasal spray administration)

DRUG

BAY2586116 (B1)

160 μg BAY2586116 (nasal drops)

DRUG

BAY2586116 (B2)

80 μg BAY2586116 (nasal spray)

DRUG

BAY2586116 (B3)

160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril)

DRUG

BAY2586116 (C)

160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril). It is the same procedure as described under part B3.

Trial Locations (1)

5042

Adelaide Institute for Sleep Health, Bedford Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY