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

Overview

About this study

The purpose of this study is to assess the safety and tolerability of danavorexton, and the effect of danavorexton on respiratory stability in the postanesthesia care unit (PACU) in patients with moderate to severe obstructive sleep apnea (OSA) who have undergone general anesthesia for abdominal surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m\^2, inclusive.
2. The participant has an apnea-hypopnea index (AHI) or respiratory event index (REI) of 15 to 40 (inclusive) based on an in-clinic polysomnography (PSG) test or an at-home sleep test within the last 5 years. Those with suspected obstructive sleep apnea (OSA) but without a PSG-based or home sleep test-based OSA diagnosis will be included based on a STOP-Bang questionnaire ≥5 and the at-home sleep test.
3. The participant is scheduled for abdominal surgery that will include at least 1 inpatient overnight stay.
4. The participant is scheduled to undergo a surgery requiring general anesthesia and endotracheal intubation.
5. The participant's surgery, as planned, is anticipated to require use of IV opioids in the postanesthesia care unit (PACU).
6. The duration of the participant's surgery (ie, procedural time) is expected to be approximately 1.5 to 4 hours.
7. The participant has an American Society of Anesthesiologists (ASA) Classification of II to III.

Exclusion Criteria:

1. The participant is undergoing liver or kidney surgery.
2. The participant has a planned transfer to the intensive care unit (ICU) from the operating room.
3. For the participant, immediate continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) use in the PACU is anticipated or planned.
4. The participant has undergone major surgery or donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
5. The participant has received chemotherapy or radiation therapy within 4 weeks before administration of the study drug.
6. The participant has poorly controlled diabetes with an episode of ketoacidosis within 6 months of the screening visit.
7. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), human immunodeficiency virus (HIV) antibody/antigen at screening.
8. 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.
9. 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).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/16/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Alberto Ardon, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ricardo Verdiner, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
.
CLS-20559106

Mayo Clinic Footer