Not currently recruiting at UCSD

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

a study on Sleep Apnea Sleep Disorders Anesthesia

Summary

Eligibility
for people ages 30-75 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Gabriel

Description

Summary

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Infusion of Danavorexton in Participants With Moderate to Severe Obstructive Sleep Apnea Undergoing General Anesthesia for Abdominal Surgery

Details

The drug being tested in this study is called danavorexton. Danavorexton is being tested in people who have moderate to severe obstructive sleep apnea undergoing general anesthesia for abdominal surgery.

The study will enroll approximately 180 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three groups-which will remain undisclosed/unknown to the participant and study doctor during the study (unless there is an urgent medical need):

  • Danavorexton high dose
  • Danavorexton low dose
  • Placebo All participants will receive an intravenous (IV) infusion on Day 1 of the treatment period.

This multi-center study will be conducted in approximately 20 sites in the United States. The overall time for participants to participate in the study will be up to approximately 12 months.

Keywords

Sleep Apnea, Drug Therapy, Obstructive Sleep Apnea, Apnea, Sleep Apnea Syndromes, Danavorexton

Eligibility

You can join if…

Open to people ages 30-75

  1. The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m2, 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.

You CAN'T join if...

  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).

Locations

  • UCSD not yet accepting patients
    La Jolla California 92037-1300 United States
  • Cedars Sinai Medical Hospital not yet accepting patients
    West Hollywood California 90048 United States

Lead Scientist at UCSD

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT05814016
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 180 study participants
Last Updated