Phase
Condition
Sleep Disorders
Sleep Apnea Syndromes
Treatment
Placebo
Danavorexton
Clinical Study ID
Ages 30-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m^2,inclusive.
The participant has diagnosed or suspected moderate or severe obstructive sleepapnea (OSA) based on one of the criteria below: a. The participant has a snoring, tiredness, observed apnea, high blood pressure,body mass index, age, neck circumference, and gender questionnaire (STOP-Bang) score ≥5 at the screening visit. OR b. The participant has a diagnosis of moderate orsevere OSA based on an in-clinic polysomnography (PSG) or home sleep test with anapnea-hypopnea index (AHI) or respiratory event index (REI) score of ≥15 and theyhave not had significant weight loss since their diagnostic test, in the judgment ofthe investigator.
The participant is scheduled for major abdominal surgery invading theintraperitoneal or retroperitoneal space (open or laparoscopic) that will require atleast 1 inpatient overnight stay.
The participant is scheduled to undergo a surgery requiring general anesthesia andendotracheal intubation.
The participant's surgery, as planned, is anticipated to require use of IV opioidsin the postanesthesia care unit (PACU).
The duration of the participant's surgery (i.e., incision to last stitch) isexpected to be at least 2 hours and up to approximately 8 hours.
The participant has an American Society of Anesthesiologists (ASA) Classification ofII to III.
Exclusion
Key Exclusion Criteria:
The participant has an AHI or REI score <15 based on in-clinic PSG test or at-homesleep test within 2 years before screening.
The participant is undergoing liver or kidney surgery.
The participant has a planned transfer to the intensive care unit (ICU) from theoperating room.
For the participant, immediate (continuous positive airway pressure [CPAP]/ bilevelpositive airway pressure [BiPAP]) use in the PACU is anticipated or planned.
The participant has undergone major surgery or donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
The participant has received chemotherapy or radiation therapy within 4 weeks beforeadministration of the study drug.
The participant has poorly controlled diabetes with an episode of ketoacidosiswithin 6 months of the screening visit.
The participant has a positive test result for hepatitis B surface antigen,hepatitis C virus (HCV), human immunodeficiency virus antibody/antigen at screening.
The participant has uncontrolled hypertension or unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, myocardial infarction <3months, severe valvular disease, or severe structural heart disease), severe heartfailure, or any condition requiring a pacemaker or defibrillator.
The participant has a screening electrocardiogram (ECG) with a QT interval withFridericia correction method (QTcF) >450 milliseconds [ms] (for men) or >470 ms (forwomen).
Study Design
Study Description
Connect with a study center
Helen Keller Hospital
Sheffield, Alabama 35660-6334
United StatesSite Not Available
Mayo Clinic - PPDS - Hospital
Phoenix, Arizona 85054-4502
United StatesSite Not Available
UCSD
La Jolla, California 92037-1300
United StatesSite Not Available
Cedars Sinai Medical Hospital
West Hollywood, California 90048
United StatesSite Not Available
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida 32224-1865
United StatesSite Not Available
Medical Research Center - Clinic/Outpatient Facility
Miami, Florida 33165
United StatesSite Not Available
University of Miami - Leonard M. Miller School of Medicine
Miami, Florida 33136-1005
United StatesSite Not Available
University of South Florida
Tampa, Florida 33606-3601
United StatesSite Not Available
Cleveland Clinic Florida
Weston, Florida 33331-3609
United StatesSite Not Available
Rush University
Chicago, Illinois 60622
United StatesSite Not Available
University of Louisville - Hospital
Louisville, Kentucky 40202-3700
United StatesSite Not Available
Brigham and Womens Hospital
Boston, Massachusetts 02115-6110
United StatesSite Not Available
Barnes Jewish Hospital
Saint Louis, Missouri 63108-1495
United StatesSite Not Available
Inspira Health
Mullica Hill, New Jersey 09061
United StatesSite Not Available
NYU Langone
Mineola, New York 11501-3893
United StatesSite Not Available
Stony Brook University Medical Center
Stony Brook, New York 11794-0001
United StatesSite Not Available
Cleveland Clinic Hospital
Cleveland, Ohio 44195-0001
United StatesSite Not Available
Fairview Hospital
Cleveland, Ohio 44111-5612
United StatesSite Not Available
Ohio State University Wexner Medical Center
Columbus, Ohio 43210-1240
United StatesSite Not Available
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin 53226-3522
United StatesSite Not Available
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