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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 19
- 主要终点
- Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)
研究概览
简要总结
The main aim is to see if danavorexton can help improve people's breathing in the recovery room after abdominal surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a body mass index (BMI) within the range of 18.5 to 50 kg/m^2, inclusive.
- •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.
- •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.
- •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 (i.e., incision to last stitch) is expected to be at least 2 hours and up to approximately 8 hours.
- •The participant has an American Society of Anesthesiologists (ASA) Classification of II to III.
排除标准
- •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.
- •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 [CPAP]/ bilevel positive airway pressure [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 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).
研究组 & 干预措施
High Dose Danavorexton
Participants will receive danavorexton intravenous (IV) infusion as high dose on Day 1 of the treatment period.
干预措施: Danavorexton (Drug)
Low Dose Danavorexton
Participants will receive danavorexton IV infusion as low dose on Day 1 of the treatment period.
干预措施: Danavorexton (Drug)
Placebo
Participants will receive a placebo-matching danavorexton IV infusion on Day 1 of the treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants who Maintain Respiratory Stability for 120 Minutes in the Postanesthesia Care Unit (PACU)
时间窗: 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.
次要结局
- Number of Participants with At Least One Occurrence of ≥1 MAV in Post-Study Drug Vital Signs(Up to 12 months)
- Number of Participants with At Least One Occurrence of ≥1 Markedly Abnormal Value (MAV) in Post-Study Drug Laboratory Values(Up to 12 months)
- Number of Participants with At Least One Occurrence of ≥1 MAV on Post-Study Drug ECGs(Up to 12 months)
- Number of Episodes of Respiratory Instability per Participant Within 120 Minutes in the PACU(Day 1)
- 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)
- Number of Participants with At Least One Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to 12 months)