The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
41
Danavorexton IV infusion.
Placebo matching danavorexton IV infusion.
Helen Keller Hospital
Sheffield, Alabama, United States
Mayo Clinic - PPDS - Hospital
Phoenix, Arizona, United States
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.
Time frame: Day 1
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.
Time frame: 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
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.
Time frame: 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
Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs
Time frame: 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
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UCSD
La Jolla, California, United States
Cedars Sinai Medical Hospital
West Hollywood, California, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, United States
University of Miami - Leonard M. Miller School of Medicine
Miami, Florida, United States
Medical Research Center - Clinic/Outpatient Facility
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Rush University
Chicago, Illinois, United States
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