SANDMAN
Research type
Research Study
Full title
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.
IRAS ID
244575
Contact name
Sophie West
Contact email
Sponsor organisation
Bayer AG
Eudract number
2017-001851-29
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a phase 2, randomised, multi-centre, double blind, placebo-controlled study to investigate the safety, tolerability and pharmacodynamics (what the medication does to the body) of a nasal spray to treat Obstructive Sleep Apnoea (OSA), called BAY2253651.
OSA is a common disorder where the walls of the throat relax and narrow during sleep, interrupting normal breathing. Approximately, 4% of middle-aged men and 2% of middle-aged women in the UK suffer from OSA; it can reduce life-expectancy by up-to 20 years. However, there is currently no pharmacological treatment for OSA.
A reflex central to controlling the stability of the airway is the genioglossus negative pressure reflex (NPR). BAY2253651, acts to increase the activity of the NPR and therefore aid maintenance of airway stability.
This study has 2 Parts; A (single dose) and B (single dose on 5-consecutive nights). Part B will only commence once favourable safety and tolerability data from the multi-dose study in healthy volunteers and ongoing DSMB monitoring of Part A is obtained. Approximately, 60 participants will participate in Part A, 30 receiving BAY2253651, and 30 placebo (no active medication). Part B will enrol participants from Part A and will form an open label (no placebo) part of the study.
Part A will consist of; 2 screening visits, a pre-dose visit, a dosing day visit- where the participant will receive BAY2253651 and sleep at the study site for monitoring, a discharge visit- the morning after sleep monitoring, and an End of study visit. In Part B dosing and sleeping will be conducted at home. Visit assessments will consist of; Physical examination, 12- lead ECG, vital signs (blood pressure and heart rate), blood sampling and recording of adverse events and contaminant medications. In part B participants will also complete a diary and perform home oximeter measurements (blood oxygen saturation).
REC name
Wales REC 1
REC reference
18/WA/0201
Date of REC Opinion
25 Jul 2018
REC opinion
Further Information Favourable Opinion