GH Deficiency (GHD)Phase 1NCT01494779
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.
A Phase 1 study testing Somatropin in people with GH Deficiency (GHD) and Growth Retardation, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and… Read more about this study
- Who is it for?
- Ages 18 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- GH Deficiency (GHD), Growth Retardation
- What is being tested?
- Somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Aug 2013
- 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 18 to 32 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Research subjects who agree with all study procedures, sign and date, of their own free will, the IC;
- Research subjects were male, aged between 18 and 32 years;
- Research subjects with body mass index greater than or equal to 20 and less than or equal to 25;
- Considered healthy subjects, both clinical and laboratory.
Who cannot join
- Have donated or lost 450 mL or more blood in the 6 months preceding the study;
- Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
- Having made use of regular medication less than two weeks to interfere with the pharmacokinetics / pharmacodynamics of the drug under study, such as glucocorticoids, anabolic steroids, androgens, estrogens and thyroid hormones;
- Present history of alcohol abuse, drug or drugs;
- Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric;
- Have made previous use of somatropin;
- Make use of energy supplements and / or be frequent consumers of soy products (eg replacement of animal milk for soy milk).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo
Alexandre Frederico, phsycian, 55 19 3871-6399, alexandre@lalclinica.com.br
Alexandre Frederico, phsycian
About this study
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).
Read the detailed description
Secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between groups.
- Conditions
- GH Deficiency (GHD), Growth Retardation
- Being tested
- Somatropin
- Keywords
- children
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
single subcutaneous dose of 5mg
SomatropinDrug
single subcutaneous dose of 5mg
| Study group | Role | What they receive |
|---|---|---|
| Somatropin Test | Experimental | Somatropin of Blausiegel Indústria e Comércio Ltda. Receives: Drug: Somatropin |
| Saizen | Active comparator | Somatropin of Merck Serono Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug.
Pharmacokinetic evaluation will be based on data obtained from the average dosage of somatropin plasma. Thus, the time of collection facilities provide the pharmacokinetic parameters AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2, which will be compared between the two formulations.
The quantification of serum somatropin kit will be performed by ELISA validated using human serum as a biological matrix.
The evaluation of the pharmacodynamics will be performed by quantifying serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.
Measured: PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours.
Secondary outcomes (1)
After administration of the drug will be evaluated for safety and tolerability of the drug through the presence of hematoma, pain, itching and local redness, as well as the incidence of adverse events directly related to somatropin.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startMar 2013
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GH Deficiency (GHD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494779
- Sponsor's protocol ID
- SOMBLA0911
- Other IDs
- Version 1
- Status last verified
- Sep 2012
- First submitted
- 28 Nov 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Somatropin Produced by Laboratory Blausiegel Indústria e Comércio Ltda., Compared to Saizen® From Laboratory Merck Serono S.A.
- ClinicalTrials.gov ID
- NCT01494779
- Acronym / sponsor ID
- SOMBLA0911
- Conditions
- GH Deficiency (GHD), Growth Retardation
- Keywords
- children
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 19 Dec 2011 (estimated)
- 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.
The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect between two preparations of somatropin (T and C) after a single administration of 5 mg in healthy subjects by altering serum somatropin pharmacokinetic parameters (AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2) and pharmacodynamic (measurement of serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.).
Detailed description
Secondly, the investigators will observe the clinical safety and tolerability after single dose administration in subjects, by comparing clinical parameters and the incidence of adverse events between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatropin Test | Experimental | Drug: SomatropinSomatropin of Blausiegel Indústria e Comércio Ltda. |
| Saizen | Active comparator | Drug: SomatropinSomatropin of Merck Serono |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Research subjects who agree with all study procedures, sign and date, of their own free will, the IC;
- Research subjects were male, aged between 18 and 32 years;
- Research subjects with body mass index greater than or equal to 20 and less than or equal to 25;
- Considered healthy subjects, both clinical and laboratory.
Key exclusion criteria (7 listed)
- Have donated or lost 450 mL or more blood in the 6 months preceding the study;
- Having participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
- Having made use of regular medication less than two weeks to interfere with the pharmacokinetics / pharmacodynamics of the drug under study, such as glucocorticoids, anabolic steroids, androgens, estrogens and thyroid hormones;
- Present history of alcohol abuse, drug or drugs;
- Have a history of liver disease, renal, pulmonary, gastrointestinal, hematologic, or psychiatric;
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 |
|---|---|---|
| Somatropinsingle subcutaneous dose of 5mg | Drug | Somatropin Test |
| Somatropinsingle subcutaneous dose of 5mg | Drug | Saizen |
Primary outcome
The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug.
Time frame: PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours.
Pharmacokinetic evaluation will be based on data obtained from the average dosage of somatropin plasma. Thus, the time of collection facilities provide the pharmacokinetic parameters AUC0-24h, AUC0-inf, Cmax, Tmax and T1 / 2, which will be compared between the two formulations. The quantification of serum somatropin kit will be performed by ELISA validated using human serum as a biological matrix. The evaluation of the pharmacodynamics will be performed by quantifying serum levels of IGF-1 presented by the concentration-time profile, AUC 0-24h and AUC0-inf.
1 secondary outcome
After administration of the drug will be evaluated for safety and tolerability of the drug through the presence of hematoma, pain, itching and local redness, as well as the incidence of adverse events directly related to somatropin.
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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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.
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 in people with GH Deficiency (GHD) and Growth Retardation, run by Azidus Brasil at 1 site in Brazil.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Sep 2012. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Frederico, physian (55 19 3871-6399, alexandre@lalclinica.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint will be based in the investigation of pharmacokinetics and pharmacodynamics of somatropin in research subjects after administration of single dose, sc, of the drug. (time frame: PK: 0, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 9, 12, 15, 18, 24 hours. PD: 0, 6, 12, 24 hours.). 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 25 Sep 2012.