Generation of Biological Samples Positive to Somatropin for Anti-doping Control
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Seric concentration of rhGH
研究概览
简要总结
Background:
Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990, as it is known to improve physical performance.
Hypothesis:
The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows obtaining positive doping samples.
The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum.
Objectives:
Primary objective: To generate enough serum samples positive to recombinant somatropin in order to be analyzed as control samples by anti-doping laboratories.
Secondary objective: To determine the analytical parameters necessary to detect the administration of recombinant somatropin in healthy volunteers by direct and/or indirect methods.
Methods:
Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study correspond to basal samples of 2 subjects who do not receive any treatment.
详细描述
A blood sample volume of 450 mL is obtained from each subject receiving the treatment condition to perform the proposed tests.
In order to validate the determination methodology of hGH variants and biomarkers, blood samples from treatment group subjects are compared to reference blood samples of 450 mL from a control group (not receiving treatment) as it is not possible to obtain a basal sample of such volume from the subjects receiving treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers between 20 and 30 years old.
- •History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- •ECG, blood and urine tests performed before the trial within normal limits. Minor or punctual variations of these limits will be allowed if, in the opinion of the principal investigator, they have no clinical significance, do not pose a risk to the subject and do not interfere in the evaluation of the product. These variations and their non-relevance will be justified in writing.
- •Body mass index [BMI: weight/height^2] between 19 and 26, and weight between 50 and 90 kg.
- •Able to understand and accept the trial procedures and sign an informed consent.
排除标准
- •Failure to meet the inclusion criteria.
- •Having suffered some organic disease or major surgery during the three months prior to the trial.
- •Suffering any type of illness, acute or chronic at the time of the study.
- •Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, dermatological, or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by it, may pose a risk for the subjects, may interfere with the objectives of the study, or may suggest an alteration in the absorption, distribution, metabolism or excretion of the drug.
- •Having suffered some kind of bone or ligament injury in the last three years.
- •History or clinical evidence of psychiatric disorders, alcoholism, drug abuse or addiction to other substances (except for nicotine) or regular consumption of psychoactive drugs. With regard to nicotine, consumers of more than 10 cigarettes/day will be excluded.
- •Alcohol consumption over 15 g/day in men and 10 g/day in women.
- •Consumers of more than 3 cups of coffee and/or tea per day, consumers of more than 3 units of cola, other stimulant drinks or equivalent per day, in the 2 months prior to the start of the study.
- •Regular intake of medication in the month preceding the study. Other kinds of medication may be admitted at the discretion of the Investigator.
- •Having donated blood or participated in studies in which there were blood draws in the previous 4 weeks.
- •History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or any of the excipients. Serious adverse drug reactions.
- •Having participated in another clinical trial with medication in the three months prior to the start of the study.
- •Subjects with contraindications to treatment with the study drug (according to the summary of product characteristics).
- •Positive serology to hepatitis B, C or HIV.
- •Being unable to understand the nature, consequences of the trial and the procedures that are asked to follow.
研究组 & 干预措施
Treatment group
Subjects receive a 14-day treatment. A 450 mL blood sample is extracted 6 hours after the last administration (day 14).
干预措施: Somatropin injection (Drug)
结局指标
主要结局
Seric concentration of rhGH
时间窗: 6 hours after last administration
Concentration of the pool of molecular variants (isoforms) of somatropin in blood
次要结局
- Changes in seric concentration of ghrelin(6 hours after last administration)
- Changes in seric concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)(6 hours after last administration)
- Changes in the proportion of somatropin isoforms(6 hours after last administration)
- Changes in seric concentration of type III procollagen (P-III-P)(6 hours after last administration)
- Changes in seric concentration of cross-linked C-terminal telopeptide of type I collagen (ICTP)(6 hours after last administration)
- Changes in seric concentration of leptin(6 hours after last administration)
- Changes in seric concentration of adiponectin(6 hours after last administration)
- Changes in seric concentration of Insulin-like Growth Factor I (IGF-I)(6 hours after last administration)