Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Glucagon for Injection (Eli Lilly) and GlucaGen® (Novo Nordisk) Administered by Subcutaneous and Intramuscular Injection in Normal, Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Glucagon maximal concentration and area under curve
研究概览
简要总结
BIOD-961 is a dry powder formulation of glucagon intended for use in a device that mixes (reconstitutes) the powder with liquid to make it easier for users to treat patients with severe hypoglycemia. The purpose of this study is to evaluate how much BIOD-961 absorbs into the bloodstream, how much it raises glucose concentrations (the intended effect) and compare to two glucagon products already on the market.
详细描述
Subjects receive on separate days, in random order one of the following: 1 mg BIOD-961 intramuscularly (IM), 1 mg Lilly (IM), 1 mg Novo (IM), 1 mg BIOD-961 subcutaneously (SC), 1 mg Lilly (SC), and 1 mg Novo (SC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index: 18.5-25.0 kg/m2 inclusive.
- •Subject has provided informed consent and has signed and dated an informed consent form before any trial-related activities.
排除标准
- •Type 1 or type 2 diabetes mellitus.
- •History of pheochromocytoma, insulinoma, glucagonoma, or glycogen storage disease.
- •History of regular alcohol consumption as defined by alcohol intake exceeding 7 drinks per week for females or 14 drinks per week for males, where 1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor.
- •Significant cardiovascular (to include New York Heart Association (NYHA) Class III or- IV functional capacity or uncontrolled hypertension), respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease.
- •Any significant cardiovascular event history, including angina, myocardial infarction, therapeutic coronary procedure (e.g, percutaneous transluminal coronary angioplasty, coronary bypass surgery), stroke, or transient ischemic attack.
- •Females who are breast feeding, pregnant, or intending to become pregnant during the study.
研究组 & 干预措施
BIOD-961, 1 mg IM
Intramuscular delivery of BIOD-961.
干预措施: BIOD-961 (Drug)
Lilly Glucagon, 1 mg IM
Intramuscular delivery of Lilly glucagon.
干预措施: Lilly Glucagon (Drug)
Novo Glucagon, 1 mg IM
Intramuscular delivery of Novo glucagon.
干预措施: Novo Glucagon (Drug)
BIOD-961, 1 mg SC
Subcutaneous delivery of BIOD-961,
干预措施: BIOD-961 (Drug)
Lilly Glucagon, 1 mg SC
Subcutaneous delivery of Lilly glucagon.
干预措施: Lilly Glucagon (Drug)
Novo Glucagon, 1 mg SC
Subcutaneous delivery of Novo glucagon.
干预措施: Novo Glucagon (Drug)
结局指标
主要结局
Glucagon maximal concentration and area under curve
时间窗: 240 minutes post dose
Glucose maximal concentration and area under curve
时间窗: 240 minutes after dose
次要结局
- Maximal glucose excursion(240 minutes after dose)
- Time to maximal glucagon concentration(240 minutes after dose)
- Time to maximal glucose concentration(240 minutes after dose)
- Area under the glucose time curve from 0 to return to baseline after blood glucose peaked(240 minutes after dose)