Back to resultsA Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery
Primary Purpose
Sleep Apnea
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Danavorexton
Placebo
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea focused on measuring Drug Therapy, Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria: The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m^2, inclusive. 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. The participant is scheduled for abdominal surgery that will include at least 1 inpatient overnight stay. The participant is scheduled to undergo a surgery requiring general anesthesia and endotracheal intubation. The participant's surgery, as planned, is anticipated to require use of IV opioids in the postanesthesia care unit (PACU). The duration of the participant's surgery (ie, procedural time) is expected to be approximately 1.5 to 4 hours. The participant has an American Society of Anesthesiologists (ASA) Classification of II to III. Exclusion Criteria: The participant is undergoing liver or kidney surgery. The participant has a planned transfer to the intensive care unit (ICU) from the operating room. For the participant, immediate continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) use in the PACU is anticipated or planned. The participant has undergone major surgery or donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit. The participant has received chemotherapy or radiation therapy within 4 weeks before administration of the study drug. The participant has poorly controlled diabetes with an episode of ketoacidosis within 6 months of the screening visit. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), human immunodeficiency virus (HIV) antibody/antigen at screening. 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. 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).
Sites / Locations
- Helen Keller HospitalRecruiting
- Mayo Clinic - PPDS - Hospital
- UCSD
- Cedars Sinai Medical Hospital
- Mayo Clinic Jacksonville - PPDS
- University of Miami - Leonard M. Miller School of Medicine
- Medical Research Center - Clinic/Outpatient FacilityRecruiting
- University of South Florida
- Cleveland Clinic Florida
- Rush University
- University of Louisville - Hospital
- Brigham and Womens Hospital
- Inspira Health
- NYU Langone
- Stony Brook University Medical Center
- Fairview Hospital
- Cleveland Clinic Hospital
- Ohio State University Wexner Medical CenterRecruiting
- The Medical College of Wisconsin, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High Dose Danavorexton
Low Dose Danavorexton
Placebo
Arm Description
Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.
Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.
Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.
Outcomes
Primary Outcome Measures
Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)
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
Number of Episodes of Respiratory Instability per Participant Within 120 Minutes in the PACU
The number of episodes of respiratory instability during 120 minutes in the PACU will be assessed.
Plasma Concentration of Danavorexton at the End of Infusion (Ceoi)
Number of Participants with At Least One Occurrence of Treatment-Emergent Adverse Events (TEAEs)
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.
Number of Participants with At Least One Occurrence of ≥1 Markedly Abnormal Value (MAV) in Post-Study Drug Laboratory Values
Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs
Number of Participants with At Least One Occurrence of ≥1 MAV on Post-Study Drug ECGs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05814016
Brief Title
A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 4, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
Drug Therapy, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Dose Danavorexton
Arm Type
Experimental
Arm Description
Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.
Arm Title
Low Dose Danavorexton
Arm Type
Experimental
Arm Description
Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.
Intervention Type
Drug
Intervention Name(s)
Danavorexton
Other Intervention Name(s)
TAK-925
Intervention Description
Danavorexton IV infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching danavorexton IV infusion.
Primary Outcome Measure Information:
Title
Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of Episodes of Respiratory Instability per Participant Within 120 Minutes in the PACU
Description
The number of episodes of respiratory instability during 120 minutes in the PACU will be assessed.
Time Frame
Day 1
Title
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
Title
Number of Participants with At Least One Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 12 months
Title
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
Title
Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs
Time Frame
Up to 12 months
Title
Number of Participants with At Least One Occurrence of ≥1 MAV on Post-Study Drug ECGs
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m^2, inclusive.
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.
The participant is scheduled for abdominal surgery that will include at least 1 inpatient overnight stay.
The participant is scheduled to undergo a surgery requiring general anesthesia and endotracheal intubation.
The participant's surgery, as planned, is anticipated to require use of IV opioids in the postanesthesia care unit (PACU).
The duration of the participant's surgery (ie, procedural time) is expected to be approximately 1.5 to 4 hours.
The participant has an American Society of Anesthesiologists (ASA) Classification of II to III.
Exclusion Criteria:
The participant is undergoing liver or kidney surgery.
The participant has a planned transfer to the intensive care unit (ICU) from the operating room.
For the participant, immediate continuous positive airway pressure/bilevel positive airway pressure (CPAP/BiPAP) use in the PACU is anticipated or planned.
The participant has undergone major surgery or donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
The participant has received chemotherapy or radiation therapy within 4 weeks before administration of the study drug.
The participant has poorly controlled diabetes with an episode of ketoacidosis within 6 months of the screening visit.
The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), human immunodeficiency virus (HIV) antibody/antigen at screening.
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.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Helen Keller Hospital
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660-6334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
256-386-4001
Email
tmelson672@aol.com
First Name & Middle Initial & Last Name & Degree
Melson
Facility Name
Mayo Clinic - PPDS - Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054-4502
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
480-342-6453
Email
verdiner.ricardo@mayo.cdu
First Name & Middle Initial & Last Name & Degree
Verdinier
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-1300
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
858-246-2569
Email
Ragabriel@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Gabriel
Facility Name
Cedars Sinai Medical Hospital
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
310-289-0224
Email
phillip.flleshner@cshs.org
First Name & Middle Initial & Last Name & Degree
Fleshner
Facility Name
Mayo Clinic Jacksonville - PPDS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-1865
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
904-280-4241
Email
ardon.alberto@mayo.edu
First Name & Middle Initial & Last Name & Degree
Ardon
Facility Name
University of Miami - Leonard M. Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1005
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
305-585-1142
Email
yrodriguez4@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Rodriguez
Facility Name
Medical Research Center - Clinic/Outpatient Facility
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
208-346-8900
Email
jarrontemresearchcenter@gmail.com
First Name & Middle Initial & Last Name & Degree
Arronte
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-3601
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
813-844-8544
Email
rbennet1@usf.edu
First Name & Middle Initial & Last Name & Degree
Bennett
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331-3609
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
954-659-5000
Email
minears@ccf.org
First Name & Middle Initial & Last Name & Degree
Minear
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
858-442-6166
Email
graham_Lubinsky@rush.edu
First Name & Middle Initial & Last Name & Degree
Lubinsky
Facility Name
University of Louisville - Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3700
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
502-629-3355
Email
robert.martin@louisville.edu
First Name & Middle Initial & Last Name & Degree
Martin
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-732-8480
Email
laglio@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Aglio
Facility Name
Inspira Health
City
Mullica Hill
State/Province
New Jersey
ZIP/Postal Code
09061
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
856-641-8000
Email
BashianC@ihn.org
First Name & Middle Initial & Last Name & Degree
Bashian
Facility Name
NYU Langone
City
Mineola
State/Province
New York
ZIP/Postal Code
11501-3893
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
516-663-9571
Email
patrizio.petrone@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Petrone
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-0001
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
631-624-7027
Email
Syed.Azim@stonybrookmedicine.edu
First Name & Middle Initial & Last Name & Degree
Azim
Facility Name
Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111-5612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
216-476-7000
Email
Saayad@ccf.org
First Name & Middle Initial & Last Name & Degree
Ayad
Facility Name
Cleveland Clinic Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
216-444-2200
Email
TURANA@ccf.org
First Name & Middle Initial & Last Name & Degree
Turan
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
614-593-3559
Email
michael.essandoh@osumc.edu
First Name & Middle Initial & Last Name & Degree
Essandoh
Facility Name
The Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
414-805-3000
Email
klauer@mcw.edu
First Name & Middle Initial & Last Name & Degree
Lauer
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/3861381ef14b4cde?idFilter=%5B%22TAK-925-1501%22%5D
Description
To obtain more information on the study, click here/on this link.
Learn more about this trial
A Study of Danavorexton in People With Obstructive Sleep Apnea After General Anesthesia for Abdominal Surgery
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