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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603678
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Drug: BAY2253651 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : May 23, 2019
Actual Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part A single dose BAY2253651
Single dose BAY2253651
Drug: BAY2253651
100 µg (500 µg/ml * 200 µl) BAY2253651 intranasally

Placebo Comparator: Part A single dose Placebo
Single dose matching placebo
Drug: Placebo
Matching Placebo dosing

Experimental: Part B multiple dose BAY2253651
Multiple dose BAY2253651 on 5 consecutive nights
Drug: BAY2253651
100 µg (500 µg/ml * 200 µl) BAY2253651 intranasally




Primary Outcome Measures :
  1. Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50% [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 7 days ]
  2. Severity of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603678


Locations
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Switzerland
University Hospital Zürich
Zürich, Switzerland, 8091
United Kingdom
Oxford University Hospitals
Oxford, United Kingdom, OX9 3DU
Sponsors and Collaborators
Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03603678    
Other Study ID Numbers: 19038
2017-001851-29 ( EudraCT Number )
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Obstructive sleep apnea
Potassium channel blocker
Polysomnography
PSG
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases