NCT04236440: KOALA

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

Completed Phase 2 Last updated 8 August 2022

What this trial tests

Phase 2 trial testing BAY2586116 (A1) in Sleep Apnea, Obstructive in 14 participants. Completed in 24 June 2021.

Timeline

4 February 2020

Primary endpoint
6 May 2021

24 June 2021

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	14
Start date	4 February 2020
Primary completion	6 May 2021
Estimated completion	24 June 2021
Sites	1 location across Australia

Drugs / interventions tested

• BAY2586116 (A1) — full drug profile →
• Placebo (A2)
• BAY2586116 (B1) — full drug profile →
• BAY2586116 (B2) — full drug profile →
• BAY2586116 (B3) — full drug profile →
• BAY2586116 (C) — full drug profile →

Conditions studied

• Sleep Apnea, Obstructive — all drugs for Sleep Apnea, Obstructive →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Sleep Apnea, Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The researchers in this study want to learn how drug BAY2586116 works in patients with obstructive sleep apnea (OSA). OSA is a sleep disorder marked by breathing pauses during sleep due to repetitive obstructions of the upper airway. BAY2586116 is a new drug under development for the treatment of OSA. It blocks protein channels expressed on the surface of the upper airways in small mechanoreceptors (a type of molecule that sense and pass stimulus outside a cell on to the inside of the cell through mechanical gate on the surface of the cell). Thus, the negative pressure reflex alerting the brain of inspiration is triggered more easily leading to a stronger activation of throat muscles. This prevents narrowing or collapse of the upper airways during sleep which is one of the pathological key factors in OSA.

Researchers will study the effects of different routes of administration (drops into the nose, spray into the nose or throat or spray into the throat by endoscopy). Endoscopy allows the doctor to look at areas in the throat that cannot be seen with a mirror: a thin tube-like instrument is inserted through the nose to check and give the medication. Different doses of the test drug will be given.

They also want to find out if participants experience any medical problems during the study.

Patients participating in this study will undergo three study parts. After completing Part A and Part B, participants will be asked to join Part C. In Part A, participants will receive both the test drug and placebo (a placebo looks like the test drug but does not have any medicine in it); in Part B, participants will receive the test drug twice via different routes of administration (drops in nose and spray in nose or throat) and in Part C, the participants would receive the test drug once via spray in throat by endoscopy. The sleep of the participants will be monitored by medical equipment. Participants will be asked to visit the clinic 7 times in 14 weeks in total.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Topical Potassium Channel Blockage Improves Pharyngeal Collapsibility: A Translational, Placebo-Controlled Trial.
   Osman AM, Mukherjee S, Altree TJ, Delbeck M, et al · · 2023 · cited 15× · PMID 36435266 · DOI 10.1016/j.chest.2022.11.024
2. BAY 2253651 for the treatment of obstructive sleep apnoea: a multicentre, double-blind, randomised controlled trial (SANDMAN).
   Gaisl T, Turnbull CD, Weimann G, Unger S, et al · · 2021 · cited 12× · PMID 34531274 · DOI 10.1183/13993003.01937-2021
3. A novel TASK channel antagonist nasal spray reduces sleep apnea severity in physiological responders: a randomized, blinded, trial.
   Osman AM, Toson B, Naik GR, Mukherjee S, et al · · 2024 · cited 10× · PMID 38214905 · DOI 10.1152/ajpheart.00541.2023