NCT04042428

Generation of Biological Samples Positive to Somatropin for Anti-doping Control

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 20 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Somatropin injection	Subjects receive a daily subcutaneous dose of 0.2 IU/kg (0.067 mg/kg) of recombinant somatropin (rhGH) during 14 days.

Timeline

• Start date: 2019-10-25
• Primary completion: 2020-01-08
• Completion: 2020-01-08
• First posted: 2019-08-02
• Last updated: 2020-02-12

Locations

1 site across 1 country: Spain