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Trial record 1 of 3 for:    danavorexton
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A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT05814016
Recruitment Status : Recruiting
First Posted : April 14, 2023
Last Update Posted : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease Intervention/treatment Phase
Sleep Apnea Drug: Danavorexton Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : May 25, 2023
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : March 2, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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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 Name: 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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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.

  4. 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 ]
  5. Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs [ Time Frame: Up to 12 months ]
  6. Number of Participants with At Least One Occurrence of ≥1 MAV on Post-Study Drug ECGs [ Time Frame: Up to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05814016


Contacts
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Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com

Locations
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Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
More Information
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Additional Information:

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT05814016    
Other Study ID Numbers: TAK-925-1501
First Posted: April 14, 2023    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Obstructive Sleep Apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases