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

April 30, 2024 updated by: Takeda

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660-6334
        • Recruiting
        • Helen Keller Hospital
        • Contact:
        • Principal Investigator:
          • Melson
    • Arizona
      • Phoenix, Arizona, United States, 85054-4502
        • Not yet recruiting
        • Mayo Clinic - PPDS - Hospital
        • Contact:
        • Principal Investigator:
          • Verdinier
    • California
      • La Jolla, California, United States, 92037-1300
        • Not yet recruiting
        • UCSD
        • Contact:
        • Principal Investigator:
          • Gabriel
      • West Hollywood, California, United States, 90048
        • Not yet recruiting
        • Cedars Sinai Medical Hospital
        • Contact:
        • Principal Investigator:
          • Fleshner
    • Florida
      • Jacksonville, Florida, United States, 32224-1865
        • Not yet recruiting
        • Mayo Clinic Jacksonville - PPDS
        • Contact:
        • Principal Investigator:
          • Ardon
      • Miami, Florida, United States, 33136-1005
        • Not yet recruiting
        • University of Miami - Leonard M. Miller School of Medicine
        • Principal Investigator:
          • Rodriguez
        • Contact:
      • Miami, Florida, United States, 33165
        • Recruiting
        • Medical Research Center - Clinic/Outpatient Facility
        • Contact:
        • Principal Investigator:
          • Arronte
      • Tampa, Florida, United States, 33606-3601
        • Not yet recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Bennett
      • Weston, Florida, United States, 33331-3609
        • Not yet recruiting
        • Cleveland Clinic Florida
        • Contact:
        • Principal Investigator:
          • Minear
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Not yet recruiting
        • RUSH University
        • Contact:
        • Principal Investigator:
          • Lubinsky
    • Kentucky
      • Louisville, Kentucky, United States, 40202-3700
        • Not yet recruiting
        • University of Louisville - Hospital
        • Contact:
        • Principal Investigator:
          • Martin
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-6110
        • Not yet recruiting
        • Brigham and Womens Hospital
        • Contact:
        • Principal Investigator:
          • Aglio
    • New Jersey
      • Mullica Hill, New Jersey, United States, 09061
        • Not yet recruiting
        • Inspira Health
        • Contact:
        • Principal Investigator:
          • Bashian
    • New York
      • Mineola, New York, United States, 11501-3893
      • Stony Brook, New York, United States, 11794-0001
        • Not yet recruiting
        • Stony Brook University Medical Center
        • Contact:
        • Principal Investigator:
          • Azim
    • Ohio
      • Cleveland, Ohio, United States, 44195-0001
        • Not yet recruiting
        • Cleveland Clinic Hospital
        • Contact:
        • Principal Investigator:
          • Turan
      • Cleveland, Ohio, United States, 44111-5612
        • Not yet recruiting
        • Fairview Hospital
        • Contact:
        • Principal Investigator:
          • Ayad
      • Columbus, Ohio, United States, 43210-1240
        • Recruiting
        • Ohio State University Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Essandoh
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Not yet recruiting
        • The Medical College of Wisconsin, Inc.
        • Contact:
        • Principal Investigator:
          • Lauer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 sleep apnea (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 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.

  3. 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.
  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 (i.e., incision to last stitch) is expected to be at least 2 hours and up to approximately 8 hours.
  7. The participant has an American Society of Anesthesiologists (ASA) Classification of II to III.

Key Exclusion Criteria:

  1. 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.
  2. The participant is undergoing liver or kidney surgery.
  3. The participant has a planned transfer to the intensive care unit (ICU) from the operating room.
  4. For the participant, immediate (continuous positive airway pressure [CPAP]/ bilevel positive 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 before administration of the study drug.
  7. The participant has poorly controlled diabetes with an episode of ketoacidosis within 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 <3 months, severe valvular disease, or severe structural heart disease), severe heart failure, or any condition requiring a pacemaker or defibrillator.
  10. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose Danavorexton
Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.
Drug: Danavorexton
Danavorexton IV infusion.
Other Names:
  • TAK-925
Experimental: Low Dose Danavorexton
Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.
Drug: Danavorexton
Danavorexton IV infusion.
Other Names:
  • TAK-925
Placebo Comparator: Placebo
Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.
Drug: Placebo
Placebo matching danavorexton IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)
Time Frame: Day 1
Respiratory stability in the PACU will be considered as having been achieved if the participant can breathe without problems for 120 minutes in the PACU.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Episodes of Respiratory Instability per Participant Within 120 Minutes in the PACU
Time Frame: Day 1
The number of episodes of respiratory instability during 120 minutes in the PACU will be assessed.
Day 1
Plasma Concentration of Danavorexton at the End of Infusion (Ceoi)
Time Frame: Pre-dose within 1 hour before surgery and 24 hours post start of the infusion up to Day 2
Pre-dose within 1 hour before surgery and 24 hours post start of the infusion up to Day 2
Number of Participants with At Least One Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 12 months
TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Up to 12 months
Number of Participants with At Least One Occurrence of ≥1 Markedly Abnormal Value (MAV) in Post-Study Drug Laboratory Values
Time Frame: Up to 12 months
Up to 12 months
Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs
Time Frame: Up to 12 months
Up to 12 months
Number of Participants with At Least One Occurrence of ≥1 MAV on Post-Study Drug ECGs
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

March 2, 2025

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-925-1501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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