check_circleStudy Completed

Sleep Apnea, Obstructive

Obstructive Sleep Apnea (OSA) treated with a Potassium Channel Inhibitor

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
34
Trial Dates
August 2018 - September 2019
Phase
Phase 2
Could I Receive a placebo
Yes
Products
BAY2253651
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Oxford University HospitalsOxford, OX9 3DU, United Kingdom
Withdrawn
Freeman HospitalNewcastle Upon Tyne, NE7 7DN, United Kingdom
Completed
University Hospital ZürichZürich, 8091, Switzerland

Primary Outcome

  • Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50%
    date_rangeTime Frame:
    2 days

Secondary Outcome

  • Incidence of treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 7 days
  • Severity of treatment emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 7 days

Trial design

Randomized, multi-center, double-blind, placebo-controlled, group-comparison study to investigate safety, tolerability and pharmacodynamics of BAY2253651 after administration of a single nasal dose in 60 subjects with obstructive sleep apnea and open exploratory evaluation of safety and local tolerability of repeated doses in patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3