Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Profile (area under the curve AUC)
研究概览
简要总结
WHAT IS THE PURPOSE OF THIS RESEARCH STUDY
This research study is designed to demonstrate that intramuscular (IM) Injection of FDA Approved Naloxone Hydrochloride (HCI) given in the forearm muscle is approximately the same as given the injection in the buttocks muscle. STAT Therapeutics Inc. is sponsoring this research study.
BACKGOUND AND PURPOSE FOR THIS STUDY
You are being asked to participate in this research study because you are between the ages of 18 and 55 and appear to be in stable health. Naloxone HCI is FDA approved and has been used to treat symptoms of opioid overdose for over 40 years. This research study is designed to demonstrate that intramuscular (IM) Injection of FDA Approved Naloxone Hydrochloride (HCI) given in the forearm is approximately the same as given the injection in the buttocks.
This is the first time Naloxone Hydrochloride (HCI) is given in the forearm muscle.
This is an open-label study. This means that you, the Doctor, study staff, and the Sponsor will know the study drug and the dose that you are given.
详细描述
WHAT IS THE PURPOSE OF THIS RESEARCH STUDY
This research study is designed to demonstrate that intramuscular (IM) Injection of FDA Approved Naloxone Hydrochloride (HCI) given in the forearm muscle is approximately the same as given the injection in the buttocks muscle. STAT Therapeutics Inc. is sponsoring this research study.
BACKGOUND AND PURPOSE FOR THIS STUDY
You are being asked to participate in this research study because you are between the ages of 18 and 55 and appear to be in stable health. Naloxone HCI is FDA approved and has been used to treat symptoms of opioid overdose for over 40 years. This research study is designed to demonstrate that intramuscular (IM) Injection of FDA Approved Naloxone Hydrochloride (HCI) given in the forearm is approximately the same as given the injection in the buttocks.
This is the first time Naloxone Hydrochloride (HCI) is given in the forearm muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 55 years of age
- •Body mass index (BMI) 18 to 30 kg/m2
- •Subjects who do not take prescribed or OTC medications on a regular basis. In the case of recent sporadic use for minor illness, the subject may be enrolled if the investigator deems the use insignificant to study.
- •Nonsmokers and subjects who smoked 10 or fewer cigarettes per day.
- •Be willing to spend at least 12 hours in the study facility.
排除标准
- •Subjects who do not fulfill criteria as described in Inclusion Criteria above
- •Abnormal wrist or forearm anatomy (or history of prior wrist/forearm surgery).
- •Difficult venous access for blood draws
- •Active infection in including respiratory tract infection
- •Used opioid analgesics for pain relief within the previous 14 days, or, in the judgment of the investigator, had significant acute or chronic medical conditions.
- •Known previous or concomitant serious illness or medical condition such as malignancy, HIV, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may interfere with participation in the study
- •Previous Substance Use Disorder (SUD) with injectable drugs.
- •Compromised cardiovascular system (history of myocardial infarction- MI, angina, etc., at discretion of principal investigator- PI).
研究组 & 干预措施
Naloxone intramuscular (IM)
intramuscular (IM) to extensor digitorum communis (EDC)/forearm muscle
干预措施: naloxone IM (Drug)
结局指标
主要结局
Pharmacokinetic Profile (area under the curve AUC)
时间窗: 1 day
Area under the Curve (AUC)
次要结局
- PK Profile (Cmax, Tmax, T/2- half-life)(1 day)