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| Sponsor: | Phage Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Phage Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00489294 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Hormone Deficiency |
Drug: Syntropin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers |
| Enrollment: | 20 |
| Study Start Date: | March 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria
Contacts and Locations
More Information
| Responsible Party: | Allan Goldberg, Ph.D, Phage Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00489294 History of Changes |
| Other Study ID Numbers: | SYN-05-001 |
| Study First Received: | June 19, 2007 |
| Last Updated: | December 13, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Human growth hormone idiopathic short stature short stature |
|
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |