Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control

NCT02920359 | Completed Phase 1

• 2 other identifiers: IMIMFTCL/LEUPRO2016-002719-16
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters that reveal the administration of Leuprorelin acetate in healthy volunteers with these methods.

Conditions

There Are no Conditions Under Study. Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Urine concentrations of leuprorelin acetate

  Urine samples will be collected in two intervals after the administration of leuprorelin acetate (0-3h; 3-6h) in all experimental study sessions (3 consecutive days).

  From the administration to 6 hours post-administration

Study Arms (1)

LEUPRORELIN ACETATE

EXPERIMENTAL

Drug: LEUPRORELIN ACETATE

Interventions

LEUPRORELIN ACETATE DRUG

LEUPRORELIN ACETATE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers aged from 18 to 45 years.
• Understanding and accepting the study procedures and signing the informed consent form.
• A health profile devoid of organic or physiological disorders.
• The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
• Body mass index (BMI=weigh/height2) will range between 19 and 25 Kg/m2 and weight between 50 and 100 kg. BMI between 25 and 27 kg/m2 can be included by principal investigator criteria.

You may not qualify if:

• History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance, similar nonapeptides or any excipients.
• History of allergy or adverse reactions to any medication.
• Subjects for which the drug involved in the study is counter indicated.
• History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
• History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
• Have been volunteer in another study with drugs in the last 3 months prior to start this study.
• Have taken part in studies with blood donation in the last 2 months prior to start this study.
• Having suffered any organic disease or major surgery in the six months prior to start this study.
• A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease that, in the investigator's opinion, considering the current state of the art, they are clinically significant, are life-threatening for the subjects and could interfere with the product assessment. Especially seizures or a history of epilepsy.
• Smokers of more than 20 cigarettes per day in the last 3 months prior to start this study.
• Taking more than 40 g of alcohol per day.
• Drinking more than 5 cups per day of coffee, tea, coke, stimulants or equivalent, or drinks containing xanthines, in the 3 months prior to start this study.
• Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
• Subjects with positive serology for hepatitis B, C or HIV.
• Subjects with anormal values of testosterone or prostate-specific antigen according to age normal values.

Sponsors & Collaborators

• Parc de Salut Mar: lead

MeSH Terms

Interventions

Leuprolide

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: November 17, 2016
• Primary Completion: December 13, 2016
• Study Completion: September 30, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10