A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery

Ki vehet részt

• 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 sleep apnea (OSA) based on one of the criteria below:; 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 or severe OSA based on an in-clinic polysomnography (PSG) or home sleep test with an apnea-hypopnea index (AHI) or respiratory event index (REI) score of ≥15 and they have not had significant weight loss since their diagnostic test, in the judgment of the investigator
• The participant is scheduled for major abdominal surgery invading the intraperitoneal or retroperitoneal space (open or laparoscopic) that will require at least 1 inpatient overnight stay
• The participant is scheduled to undergo a surgery requiring general anesthesia and endotracheal intubation
• The participant's surgery, as planned, is anticipated to require use of IV opioids in the postanesthesia care unit (PACU)
• The duration of the participant's surgery (i.e., incision to last stitch) is expected to be at least 2 hours and up to approximately 8 hours
• The participant has an American Society of Anesthesiologists (ASA) Classification of II to III

Ki nem vehet részt

• The participant is undergoing liver or kidney surgery
• 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 before administration of the study drug
• The participant has poorly controlled diabetes with an episode of ketoacidosis within 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 <3 months, severe valvular disease, or severe structural heart disease), severe heart failure, or any condition requiring a pacemaker or defibrillator
• The participant has a screening electrocardiogram (ECG) with a QT interval with Fridericia correction method (QTcF) >450 milliseconds [ms] (for men) or >470 ms (for women)
• The participant has an AHI or REI score <15 based on in-clinic PSG test or at-home sleep test within 2 years before screening
• The participant has a planned transfer to the intensive care unit (ICU) from the operating room
• For the participant, immediate (continuous positive airway pressure [CPAP]/ bilevel positive airway pressure [BiPAP]) use in the PACU is anticipated or planned