NCT02735629Unknown2 期
Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
RespireRx1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Respiratory depression
研究概览
简要总结
The study is an investigation to assess the capacity of ascending doses of CX1739 to antagonize the respiratory depressive effect of remifentanil. The study will also investigate whether ascending doses of CX1739 reduce the analgesic effect of remifentanil or alter the BIS measure of sedation and will evaluate the safety of CX1739 when used in conjunction with remifentanil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •To be eligible for this trial, subjects must meet all of the following criteria:
- •Males 18 to 50 years of age, inclusive
- •Body mass index of 18.0 to 30.0 kg/m2, inclusive, using the formula: weight (kg)/height (m)2
- •Healthy, as determined by medical history, physical examination including vital signs, and clinical laboratory test results
- •American Society of Anesthesiologists Physical Status Classification 1
- •Willing and able to provide voluntary, written informed consent
排除标准
- •If a subject meets any of the following criteria, he cannot be enrolled in the study:
- •History of any chronic illness or evidence of clinically significant organic or psychiatric disease on medical history or physical examination which, in the opinion of the principal investigator (PI), would confound the study results or present a risk to the subject
- •Acute illness within 2 weeks before dosing
- •History of any clinically significant pulmonary condition (eg, asthma) within the last 2 years requiring admission to the hospital
- •Previous diagnosis of obstructive sleep apnea based on polysomnography
- •Currently using any prescription medication or use within the last 30 days
- •Laboratory values (clinical chemistry, hematology, urinalysis) outside the laboratory reference range considered clinically significant (NOTE: in the event of any parameter lying outside of the normal range, the sample may be repeated once; this value will be accepted if it lies within the normal range)
- •Presence of QT interval corrected > 440 msec on ECG
- •Resting HR while awake < 45 or > 90 beats/minute
- •History of daily use of tobacco or other nicotine-containing products within 1 year of study entry or positive cotinine test at screening and subsequent study visits
- •History of allergic hypersensitivity to ampakines (CX717, CX1739), remifentanil, naloxone, or any component of these formulations; history of multiple drug allergies
- •History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; positive urine drug screen (UDS) for drugs of abuse at screening
- •Inability to understand the protocol requirements; instructions; study-related restrictions; or nature, scope, and possible consequences of the study
- •Unlikely to complete the study, eg, because of inability to return for follow-up visits
- •Participation in another study with any investigational drug in the 3 months preceding this study
- •Blood or plasma donation of more than 500 mL during the month before randomization and more than 50 mL in the 2 weeks before randomization
研究组 & 干预措施
CX1739 - 300 mg
Experimental
Study Drug - low dose
干预措施: CX1739 - 300 mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
CX1739 - 600 mg
Experimental
Study drug - mid Dose
干预措施: CX1739 - 600 mg (Drug)
CX1739 - 900 mg
Experimental
Study drug - high dose
干预措施: CX1739 - 900 mg (Drug)
结局指标
主要结局
Respiratory depression
时间窗: Sequence #1 - 30 minutes
Respiratory rate, tidal volume, minute volume as determined by plethysmography
次要结局
- The number of patients that experience an adverse drug reaction upon ingestion of CX1739 when used alone or in conjunction with remifentanil(up to 5 weeks)
- Change in pupil size(Sequence #2 - 20 minutes)
- Maintenance of sedation(Sequence #1 - 30 minutes)
- Pain tolerance threshold(Sequence #2 - 20 minutes)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)Patients monitored by capnoGraphYJPRN-UMIN000026993Covidien Japan Inc.1,650
已完成
不适用
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphYopoid induced RDrespiratory depression10038716NL-OMON42863Medtronic B.V.330
终止
1 期
Reversal of Opioid-induced Respiratory Depression With Opioid AntagonistsOpioid Induced Respiratory DepressionChronic Opioid UseNCT05338632Leiden University Medical Center58
已完成
不适用
Respiratory Control and Narcotic EffectsVentilatory DepressionOpioid IntoxicationOpioid ToxicityNCT04047550Duke University10
终止
3 期
ARrest RESpiraTory Failure From PNEUMONIACOVID-19 PneumoniaAcute Respiratory FailurePneumoniaHypoxemiaNCT04193878Stanford University465