Healthy VolunteersPhase 1GH5NCT04042428
Generation of Biological Samples Positive to Somatropin for Anti-doping Control
A Phase 1 study testing Somatropin injection in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Somatropin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2019to 8 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Somatropin injection
- Keywords
- Somatropin, Growth hormone, Anti-doping control, Athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin injectionDrug
Subjects receive a daily subcutaneous dose of 0.2 IU/kg (0.067 mg/kg) of recombinant somatropin (rhGH) during 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subjects receive a 14-day treatment. A 450 mL blood sample is extracted 6 hours after the last administration (day 14). Receives: Drug: Somatropin injection |
| Control group | No intervention | Subjects do not receive any treatment. A 450 mL blood sample is extracted at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seric concentration of rhGH
Concentration of the pool of molecular variants (isoforms) of somatropin in blood
Measured: 6 hours after last administration
Secondary outcomes (8)
Changes in the proportion of somatropin isoforms
Variation of the concentration in blood of each somatropin isoform after rhGH administration
Measured: 6 hours after last administration
Changes in seric concentration of ghrelin
Variation of seric concentration of ghrelin (biomarker) in blood after rhGH administration
Measured: 6 hours after last administration
Changes in seric concentration of leptin
Variation of seric concentration of leptin (biomarker) in blood after rhGH administration
Measured: 6 hours after last administration
Changes in seric concentration of adiponectin
Variation of seric concentration of adiponectin (biomarker) in blood after rhGH administration
Measured: 6 hours after last administration
Changes in seric concentration of type III procollagen (P-III-P)
Variation of seric concentration of type III procollagen (biomarker) in blood after rhGH administration
Measured: 6 hours after last administration
Changes in seric concentration of cross-linked C-terminal telopeptide of type I collagen (ICTP)
Variation of seric concentration of cross-linked C-terminal telopeptide of type I collagen (biomarker) in blood after rhGH administration
Measured: 6 hours after last administration
Changes in seric concentration of Insulin-like Growth Factor I (IGF-I)
Variation of seric concentration of Insulin-like Growth Factor I (biomarker) in blood after rhGH administration
Measured: 6 hours after last administration
Changes in seric concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
Variation of seric concentration of Insulin-like Growth Factor Binding Protein 3 (biomarker) in blood after rhGH administration
Measured: 6 hours after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start25 Oct 2019
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Samples from treatment group are compared to samples from control group (not receiving treatment). It is not possible to use a basal sample of the subjects receiving treatment as a comparator since a minimum period of 2 months' time is required between a 450 mL extraction and another.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana M Aldea Perona, Dr, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042428
- Sponsor's protocol ID
- IMIMFTCL/GH/5
- Acronym
- GH5
- Status last verified
- Jul 2019
- First submitted
- 31 Jul 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Biological Samples Positive to Somatropin for Anti-doping Control
- ClinicalTrials.gov ID
- NCT04042428
- Acronym / sponsor ID
- GH5 / IMIMFTCL/GH/5
- Conditions
- Healthy Volunteers
- Keywords
- Somatropin, Growth hormone, Anti-doping control, Athletic performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Samples from treatment group are compared to samples from control group (not receiving treatment). It is not possible to use a basal sample of the subjects receiving treatment as a comparator since a minimum period of 2 months' time is required between a 450 mL extraction and another.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Somatropin injectionSubjects receive a 14-day treatment. A 450 mL blood sample is extracted 6 hours after the last administration (day 14). |
| Control group | No intervention | –Subjects do not receive any treatment. A 450 mL blood sample is extracted at baseline. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin injectionSubjects receive a daily subcutaneous dose of 0.2 IU/kg (0.067 mg/kg) of recombinant somatropin (rhGH) during 14 days. | Drug | Treatment group |
Primary outcome
Seric concentration of rhGH
Time frame: 6 hours after last administration
Concentration of the pool of molecular variants (isoforms) of somatropin in blood
8 secondary outcomes
Changes in the proportion of somatropin isoforms
Time frame: 6 hours after last administration
Changes in seric concentration of ghrelin
Time frame: 6 hours after last administration
Changes in seric concentration of leptin
Time frame: 6 hours after last administration
Changes in seric concentration of adiponectin
Time frame: 6 hours after last administration
Changes in seric concentration of type III procollagen (P-III-P)
Time frame: 6 hours after last administration
Changes in seric concentration of cross-linked C-terminal telopeptide of type I collagen (ICTP)
Time frame: 6 hours after last administration
Changes in seric concentration of Insulin-like Growth Factor I (IGF-I)
Time frame: 6 hours after last administration
Changes in seric concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
Time frame: 6 hours after last administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M Aldea Perona, Dr principal investigator
IMIM (Hospital del Mar Medical Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Somatropin injection in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seric concentration of rhGH (time frame: 6 hours after last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.