Growth Hormone DeficiencyPhase 1NCT00489294
Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
A Phase 1 study testing Syntropin in people with Growth Hormone Deficiency, run by Phage Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Syntropin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jun 2005
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects between the ages of 18 and 45 years (inclusive).
- Written informed consent to participate in the study.
- Body mass index between 19 and 31 kg/m².
- Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from 3 months prior through 7 days following the last dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum). Subjects must have used the same method for at least 3 months prior to starting the study.
- No clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results during screening.
- Screening growth hormone and insulin-like growth factor I (IGF-I) within normal limits.
Who cannot join
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principle Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- A history of allergic or adverse responses to growth hormone, glycerin, or metacresol, or any comparable or similar product.
- Subjects who (for whatever reason) have been on an abnormal diet during the four weeks preceding the study.
- Subjects who donated blood within 30 days or plasma within 14 days of the first study dosing.
- Participation in a clinical trial within 30 days prior to study initiation.
- Use of any over-the-counter (OTC) medication, including vitamins, within 7 days prior to or during the study.
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- Use of any prescription medication within 14 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential.
- Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to or during the study.
- Smoking or use of tobacco products within 6 months prior to or during the study.
- Female subjects who are trying to conceive, are pregnant, or are lactating.
- Positive serum pregnancy test at screening or urine pregnancy test prior to each drug administration for all women regardless of childbearing potential.
- Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol or drugs of abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services
Houston, Texas, 77402
About this study
Official title: An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
Read the detailed description
Syntropin will be administered by subcutaneous injection. Eligible patients will receive a subcutaneous injection of octreodite (to suppress endogenous growth hormone secretion) 12 hours before, immediately prior to, and 12 hours after the scheduled injection of growth hormone.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Syntropin
- Keywords
- Human growth hormone, idiopathic short stature, short stature
- Medical subject headings
- Dwarfism, Pituitary, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntropinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics
Secondary outcomes (1)
serum concentrations of insulin-like growth factor-1 (IGF-1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startAug 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phage Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489294
- Sponsor's protocol ID
- SYN-05-001
- Status last verified
- Mar 2012
- First submitted
- 19 Jun 2007
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00489294
- Acronym / sponsor ID
- SYN-05-001
- Conditions
- Growth Hormone Deficiency
- Keywords
- Human growth hormone, idiopathic short stature, short stature
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Phage Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 21 Jun 2007 (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 purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
Detailed description
Syntropin will be administered by subcutaneous injection. Eligible patients will receive a subcutaneous injection of octreodite (to suppress endogenous growth hormone secretion) 12 hours before, immediately prior to, and 12 hours after the scheduled injection of growth hormone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects between the ages of 18 and 45 years (inclusive).
- Written informed consent to participate in the study.
- Body mass index between 19 and 31 kg/m².
- Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from 3 months prior through 7 days following the last dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum). Subjects must have used the same method for at least 3 months prior to starting the study.
- No clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results during screening.
Key exclusion criteria (12 listed)
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principle Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- A history of allergic or adverse responses to growth hormone, glycerin, or metacresol, or any comparable or similar product.
- Subjects who (for whatever reason) have been on an abnormal diet during the four weeks preceding the study.
- Subjects who donated blood within 30 days or plasma within 14 days of the first study dosing.
- Participation in a clinical trial within 30 days prior to study initiation.
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 |
|---|---|---|
| Syntropin | Drug | – |
Primary outcome
pharmacokinetics
1 secondary outcome
serum concentrations of insulin-like growth factor-1 (IGF-1)
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 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syntropin in people with Growth Hormone Deficiency, run by Phage Pharmaceuticals, Inc. at 1 site in United States.
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 6 inclusion and 12 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 Mar 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 United States. 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?
pharmacokinetics. 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 Mar 2012.