NCT02217826已完成1 期
Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173
Aspireo Pharmaceuticals Limited0 个研究点目标入组 8 人开始时间: 2014年8月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 主要终点
- Concentration of glucose, insulin and glucagon in plasma.
研究概览
简要总结
In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and placebo control. The main purpose of the study was to investigate the effects of each treatment on the control of plasma glucose as well as the secretion of insulin and glucagon following a standard meal.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ethnic origin: Caucasian
- •Body Mass Index (BMI): 19-27 kg/m2 inclusive
- •Medical history without clinically relevant pathologies
- •Physical examination parameters without signs of clinically relevant pathologies
- •Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) <450 ms
- •Values for hematology and for biochemistry tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator (in particular for alanine transaminase, aspartate transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, bilirubin, and α-amylase)
- •Subjects with partner of child bearing potential must be willing to practice a medically approved method of contraception (e.g., condom in combination with hormonal contraception or intrauterine device or a diaphragm with spermicide after the first drug administration and for one month after participation in the study or are vasectomized since > 6 months or has a partner being sterilized since > 6 months
- •Having given written informed consent before any study-related activities are carried out
排除标准
- •Evidence of clinically relevant pathology or disease
- •Any history of moderate or severe hypertension, hypotension or orthostatic hypotension
- •Mental handicap
- •Legal incapacity
- •Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy
- •Chronic diarrhea or other acute or chronic gastrointestinal disorders
- •Presence or history of endocrine disorders
- •Presence or history of gallstone disease
- •Known hypersensitivity to the study drug or constituent of the study drug
- •History of any relevant allergy, especially drug and/or food allergies
- •Strict vegetarian
- •Regular treatment with medications during three months prior to randomization
- •Receipt of any prescription or non-prescription medication, including multi vitamin preparations within 14 days prior randomization and for the duration of the study
- •Use of St. John's Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization
- •Participation in a clinical study within 30 days prior to randomization
- •Donation of blood (450 ml) within 60 days prior to randomization
- •Receipt of blood, blood products or plasma derivates one year prior to randomization
- •Regular smoking of >5 cigarettes per day within the past three months
- •Any history of alcohol abuse or drug addiction
- •Known consumer of drugs of abuse
- •Known to be infected with HBsAg, anti-HCV, or anti-HIV1 and HIV2
- •Consumption of abnormal quantities of coffee or tea (i.e., more than 5 cups per day [1 cup = 150 ml])
- •Any disease which in the Investigator's opinion would exclude the subject from the study.
研究组 & 干预措施
DG3173
Experimental
干预措施: DG3173 (Drug)
DG3173
Experimental
干预措施: Saline (Drug)
DG3173
Experimental
干预措施: Octreotide (Drug)
Saline
Placebo Comparator
干预措施: DG3173 (Drug)
Saline
Placebo Comparator
干预措施: Saline (Drug)
Saline
Placebo Comparator
干预措施: Octreotide (Drug)
Octreotide
Active Comparator
干预措施: DG3173 (Drug)
Octreotide
Active Comparator
干预措施: Saline (Drug)
Octreotide
Active Comparator
干预措施: Octreotide (Drug)
结局指标
主要结局
Concentration of glucose, insulin and glucagon in plasma.
时间窗: Before and 0.5h, 0.75h, 1h, 1.25 h, 1.5h, 1.75h, 2.25h, 2.75, 3.25h, 3.75h and 4.25h after drug adaministration until 4.25 hours after administration
次要结局
未报告次要终点
研究者
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