NCT02217839
已完成
1 期
Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic Study of DG3173
Aspireo Pharmaceuticals Limited0 个研究点目标入组 42 人2012年4月
适应症Healthy
概览
- 阶段
- 1 期
- 干预措施
- DG3173
- 疾病 / 适应症
- Healthy
- 发起方
- Aspireo Pharmaceuticals Limited
- 入组人数
- 42
- 主要终点
- Number of serious adverse events or withdrawals due to adverse events. Laboratory investigations (including biochemistry, hematology, and urinalysis), vital signs (blood pressure, pulse rate), and 12-lead ECG.
- 状态
- 已完成
- 最后更新
- 11年前
概览
简要总结
This multi-ascending dose study is designed to investigate the safety, tolerability, pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48 healthy volunteers.
研究者
入排标准
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
研究组 & 干预措施
DG3173
干预措施: DG3173
DG3173
干预措施: Octreotide
DG3173
干预措施: DG3173 Placebo
DG3173+Octreotide
干预措施: DG3173+Octreotide
DG3173+Octreotide
干预措施: DG3173 Placebo+Octreotide Placebo
DG3173+Octreotide
干预措施: Octreotide+DG3173 Placebo
结局指标
主要结局
Number of serious adverse events or withdrawals due to adverse events. Laboratory investigations (including biochemistry, hematology, and urinalysis), vital signs (blood pressure, pulse rate), and 12-lead ECG.
时间窗: 10 days
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