?Recombinant hGH Biomarkers Discovery?

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Healthy male and females volunteers aged from 18 to 30 years, both ages included.
- Caucasian and non-Caucasian individuals (Europeans, Africans, Asians, Indians).
- Body mass index (BMI) between 19 and 26 Kg/m2, and weight between 50 and 90 kg.
- Subjects with high level of physical training including regular high-resistance strength training, training at least 5 hours a week or an expenditure of energy of about 5000 kcal a week.
- A health profile devoid of organic or physiological disorders.
- Pass the review based on medical history, physical examination and clinical laboratory tests.
- Understand and accept the trial procedures.
- Signature of the written informed consent to participate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Non compliance of the inclusion criteria.
- Prior or current history of consumption of addictive substances (except nicotine). Smokers of more than 10 cigarettes / day should be excluded.
Have some organic disease or major surgery in the 3 months prior to the start the study.
- Suffer any kind of disease, acute or chronic, at the moment of the study.
- Regular consumers of medications that contain any of the following substances: steroids, erythropoietin (EPO), growth hormone (hGH), insulin-like growth factor-1 (IGF-1), diuretics and plasma expanders. Intake of beta blockers and glucocorticoids in asthmatics is accepted. Other medication will be accepted depending on the Principal Investigator criteria, as flu containing ephedrines.
- A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with absorption, distribution, metabolism, or excretion of the drug administered in the study. If the subjects will be at risk as decided by the Investigator.
- Suffer any kind of bone or connective tissues injuries in the last 3 months.
- A significant psychiatric disorder, alcoholism, substance abuse or dependence (except for nicotine, criteria defined above), or consumption of psychoactive drugs.
- Alcohol consumption over 15 grams per day in men and 10 grams per day in women.
- Caffeine or another drinks specified like drinking > 3 cups of coffee and tea per day, drinking > 3 units of coke, stimulants or equivalent per day, in the 2 months prior to the study.
- Have used a medication regularly in the last month previous to the start of the study. Other type of medication may be allowed, depending on the Investigator.
- To be blood donor or have taken part in studies with blood donation in the last 4 weeks prior to the study.
- History of allergy or adverse reactions to any medication.
- Have been a volunteer in another study with drugs in the last 3 months prior to start this study.
- Subjects for whom the drug involved in the study is counter indicated.
- Subjects with positive serology for hepatitis B, C or HIV.
- Women with pregnancy or in the breast-feeding period or that are taking contraception treatment during the period of the study.
- Subjects that not have capacity to understand the nature, consequences of the study or the procedures requested to follow.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The collection of biological samples positive to somatropin in the context of a controlled clinical trial study for their further use for the evaluation of biomarkers of recombinant growth hormone misuse in humans.;Primary end point(s): Blood concentration of growth hormone biomarkers that reflect the activity of the growth hormone misuse in humans. Moreover, It will be assessed the pharmacokinetics and the bio-availability of the growth hormone.;Timepoint(s) of evaluation of this end point: 20 days during 15 weeks period of evaluation of the growth hormone biomarkers;Secondary Objective: Primary Objectives:<br>- To demonstrate that concentrations of biomarkers in blood change in a dose dependent manner with the exposure to rhGH.<br>- To explore the time window in which changes in biomarkers may be detected after hrGH exposure<br><br>Secondary Objectives:<br>- To evaluate potential gender differences<br>- To evaluate potential interethnic differences

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Drugs safety and tolerability;Timepoint(s) of evaluation of this end point: From day 1 to 21 (both included) of somatropin treatment.