NCT00489294已完成1 期
An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- pharmacokinetics
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
详细描述
Syntropin will be administered by subcutaneous injection. Eligible patients will receive a subcutaneous injection of octreodite (to suppress endogenous growth hormone secretion) 12 hours before, immediately prior to, and 12 hours after the scheduled injection of growth hormone.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects between the ages of 18 and 45 years (inclusive).
- •Written informed consent to participate in the study.
- •Body mass index between 19 and 31 kg/m².
- •Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from 3 months prior through 7 days following the last dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum). Subjects must have used the same method for at least 3 months prior to starting the study.
- •No clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results during screening.
- •Screening growth hormone and insulin-like growth factor I (IGF-I) within normal limits.
- •Exclusion Criteria
- •A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principle Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •A history of allergic or adverse responses to growth hormone, glycerin, or metacresol, or any comparable or similar product.
- •Subjects who (for whatever reason) have been on an abnormal diet during the four weeks preceding the study.
- •Subjects who donated blood within 30 days or plasma within 14 days of the first study dosing.
- •Participation in a clinical trial within 30 days prior to study initiation.
- •Use of any over-the-counter (OTC) medication, including vitamins, within 7 days prior to or during the study.
- •Use of any prescription medication within 14 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential.
- •Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to or during the study.
- •Smoking or use of tobacco products within 6 months prior to or during the study.
- •Female subjects who are trying to conceive, are pregnant, or are lactating.
- •Positive serum pregnancy test at screening or urine pregnancy test prior to each drug administration for all women regardless of childbearing potential.
- •Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol or drugs of abuse.
排除标准
- 未提供
结局指标
主要结局
pharmacokinetics
次要结局
- serum concentrations of insulin-like growth factor-1 (IGF-1)
研究者
研究点 (2)
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