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

Last updated: February 7, 2025
Sponsor: Takeda
Overall Status: Terminated

Phase

2

Condition

Sleep Disorders

Sleep Apnea Syndromes

Treatment

Placebo

Danavorexton

Clinical Study ID

NCT05814016
TAK-925-1501
  • Ages 30-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key 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 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.

  3. The participant is scheduled for major abdominal surgery invading theintraperitoneal or retroperitoneal space (open or laparoscopic) that will require atleast 1 inpatient overnight stay.

  4. The participant is scheduled to undergo a surgery requiring general anesthesia andendotracheal intubation.

  5. The participant's surgery, as planned, is anticipated to require use of IV opioidsin the postanesthesia care unit (PACU).

  6. 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.

  7. The participant has an American Society of Anesthesiologists (ASA) Classification ofII to III.

Exclusion

Key Exclusion Criteria:

  1. The participant has an AHI or REI score <15 based on in-clinic PSG test or at-homesleep test within 2 years before screening.

  2. The participant is undergoing liver or kidney surgery.

  3. The participant has a planned transfer to the intensive care unit (ICU) from theoperating room.

  4. For the participant, immediate (continuous positive airway pressure [CPAP]/ bilevelpositive airway pressure [BiPAP]) use in the PACU is anticipated or planned.

  5. The participant has undergone major surgery or donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.

  6. The participant has received chemotherapy or radiation therapy within 4 weeks beforeadministration of the study drug.

  7. The participant has poorly controlled diabetes with an episode of ketoacidosiswithin 6 months of the screening visit.

  8. The participant has a positive test result for hepatitis B surface antigen,hepatitis C virus (HCV), human immunodeficiency virus antibody/antigen at screening.

  9. 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.

  10. 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

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 11, 2023
Estimated Completion Date:
September 25, 2024

Study Description

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.

Connect with a study center

  • Helen Keller Hospital

    Sheffield, Alabama 35660-6334
    United States

    Site Not Available

  • Mayo Clinic - PPDS - Hospital

    Phoenix, Arizona 85054-4502
    United States

    Site Not Available

  • UCSD

    La Jolla, California 92037-1300
    United States

    Site Not Available

  • Cedars Sinai Medical Hospital

    West Hollywood, California 90048
    United States

    Site Not Available

  • Mayo Clinic Jacksonville - PPDS

    Jacksonville, Florida 32224-1865
    United States

    Site Not Available

  • Medical Research Center - Clinic/Outpatient Facility

    Miami, Florida 33165
    United States

    Site Not Available

  • University of Miami - Leonard M. Miller School of Medicine

    Miami, Florida 33136-1005
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606-3601
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331-3609
    United States

    Site Not Available

  • Rush University

    Chicago, Illinois 60622
    United States

    Site Not Available

  • University of Louisville - Hospital

    Louisville, Kentucky 40202-3700
    United States

    Site Not Available

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115-6110
    United States

    Site Not Available

  • Barnes Jewish Hospital

    Saint Louis, Missouri 63108-1495
    United States

    Site Not Available

  • Inspira Health

    Mullica Hill, New Jersey 09061
    United States

    Site Not Available

  • NYU Langone

    Mineola, New York 11501-3893
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794-0001
    United States

    Site Not Available

  • Cleveland Clinic Hospital

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • Fairview Hospital

    Cleveland, Ohio 44111-5612
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin 53226-3522
    United States

    Site Not Available

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