Trials / Completed
CompletedNCT03603678
Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAY2253651 | 100 µg (500 µg/ml \* 200 µl) BAY2253651 intranasally |
| DRUG | Placebo | Matching Placebo dosing |
Timeline
- Start date
- 2018-08-13
- Primary completion
- 2019-05-23
- Completion
- 2019-09-02
- First posted
- 2018-07-27
- Last updated
- 2020-12-11
Locations
2 sites across 2 countries: Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT03603678. Inclusion in this directory is not an endorsement.