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

Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05814016
• Other study ID #: TAK-925-1501
• Status: Recruiting
• Phase: Phase 2
• Start date: May 25, 2023
• Est. completion date: March 2, 2025

Study information

• Verified date: April 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 2, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Danavorexton
Danavorexton IV infusion.
• Placebo
Placebo matching danavorexton IV infusion.

Locations

Country	Name	City	State
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Rush University	Chicago	Illinois
United States	Cleveland Clinic Hospital	Cleveland	Ohio
United States	Fairview Hospital	Cleveland	Ohio
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Mayo Clinic Jacksonville - PPDS	Jacksonville	Florida
United States	UCSD	La Jolla	California
United States	University of Louisville - Hospital	Louisville	Kentucky
United States	Medical Research Center - Clinic/Outpatient Facility	Miami	Florida
United States	University of Miami - Leonard M. Miller School of Medicine	Miami	Florida
United States	The Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin
United States	NYU Langone	Mineola	New York
United States	Inspira Health	Mullica Hill	New Jersey
United States	Mayo Clinic - PPDS - Hospital	Phoenix	Arizona
United States	Helen Keller Hospital	Sheffield	Alabama
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	University of South Florida	Tampa	Florida
United States	Cedars Sinai Medical Hospital	West Hollywood	California
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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.	Day 1
Secondary	Plasma Concentration of Danavorexton at the End of Infusion (Ceoi)		Pre-dose within 1 hour before surgery and 24 hours post start of the infusion up to Day 2
Secondary	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.	Up to 12 months
Secondary	Number of Participants with At Least One Occurrence of =1 Markedly Abnormal Value (MAV) in Post-Study Drug Laboratory Values		Up to 12 months
Secondary	Number of Participants with At Least One Occurrence of =1 MAV in Post-Study Drug Vital Signs		Up to 12 months
Secondary	Number of Participants with At Least One Occurrence of =1 MAV on Post-Study Drug ECGs		Up to 12 months

External Links

•   To obtain more information on the study, click here/on this link.