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

• Status: Not yet recruiting
• Trial end date: 2024-07-04
• Target enrollment: 0
• Participant gender: All

Summary

The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

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).