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临床试验/NCT02217839
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

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.

注册库
clinicaltrials.gov
开始日期
2012年4月
结束日期
2013年1月
最后更新
11年前
研究类型
Interventional
研究设计
Single Group
性别
Male

研究者

发起方
Aspireo Pharmaceuticals Limited
责任方
Sponsor

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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