Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor

Sleep Apnea, Obstructive Clinical Trial

— SANDMAN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603678
• Other study ID #: 19038
• Secondary ID: 2017-001851-29
• Status: Completed
• Phase: Phase 2
• Start date: August 13, 2018
• Est. completion date: September 2, 2019

Study information

• Verified date: December 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2, 2019
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects need to be diagnosed with OSA (obstructive sleep apnea) but should be otherwise healthy at the discretion of the investigator.

• Patients must be pretreated with CPAP (continuous positive airway pressure) for OSA for at least 3 months before randomization.

• AHI of 15-50 per hour after 48 hours of CPAP withdrawal documented by baseline PSG (polysomnography, evaluated by the site staff) and at least 4 hours of total sleep time. (One retesting allowed).

• Female subjects must be of non-childbearing potential, i.e. post-menopausal (no menses for at least 1 year prior to randomization) or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy)

• Men of reproductive potential together with their female partner(s) must agree to use at least two adequate contraception methods when sexually active. This applies for the time period between signing of the informed consent form and 3 months after the last administration of study drug.

Acceptable methods of contraception include, but are not limited to, (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception

• Only Part B: Patients having completed Part A and had valid PSG after dosing in Part A.

Exclusion Criteria:

• Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection and attending required follow up study visits.

• Neck circumference above/equal 44 cm.

• Not predominantly obstructive sleep apnea evidenced by baseline PSG.

• Severely impaired breathing within two days prior to randomization (e.g. acute nasal congestion during upper airway infection).

• Subject with known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations). Known severe respiratory tract allergies e.g. allergic asthma.

• Intake of a nasal decongestant during the intervention time (48 hours before visit 1 until end of visit 2).

• Use of any topical medication containing local anesthetics for nose and throat within 7 days before first investigational medicinal product (IMP) administration.

• Participation in another trial with an investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer before first application of study drug or concomitant participation in another clinical study with investigational medicinal product(s).

• Any other condition, which would make the subject unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months)

• Known history of severe heart failure (NYHA 3-4) or severe COPD (GOLD 3-4).

• Heavy smoking, i.e. more than 20 cigarettes per day and/or unable to stop smoking during the stay in the sleep laboratory.

• Suspicion of drug or alcohol abuse.

• Regular daily consumption of more than 1 L of xanthine-containing beverages.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• BAY2253651
100 µg (500 µg/ml * 200 µl) BAY2253651 intranasally
• Placebo
Matching Placebo dosing

Locations

Country	Name	City	State
Switzerland	University Hospital Zürich	Zürich
United Kingdom	Oxford University Hospitals	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by = 50%		2 days
Secondary	Incidence of treatment emergent adverse events (TEAEs)		Up to 7 days
Secondary	Severity of treatment emergent adverse events (TEAEs)		Up to 7 days