Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
This study has been completed.
Information provided by (Responsible Party):
Phage Pharmaceuticals, Inc.
First received: June 19, 2007
Last updated: March 9, 2012
Last verified: March 2012
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.
Growth Hormone Deficiency
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers
Primary Outcome Measures:
Secondary Outcome Measures:
- serum concentrations of insulin-like growth factor-1 (IGF-1)
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2005 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489294
|Novum Pharmaceutical Research Services
|Houston, Texas, United States, 77402 |
Phage Pharmaceuticals, Inc.
No publications provided
||Phage Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 19, 2007
||March 9, 2012
||United States: Food and Drug Administration
Keywords provided by Phage Pharmaceuticals, Inc.:
Human growth hormone
idiopathic short stature
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs