Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phage Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00489294
First received: June 19, 2007
Last updated: March 9, 2012
Last verified: March 2012
  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 1

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

Resource links provided by NLM:


Further study details as provided by Phage Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • pharmacokinetics

Secondary Outcome Measures:
  • serum concentrations of insulin-like growth factor-1 (IGF-1)

Enrollment: 20
Study Start Date: August 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489294

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77402
Sponsors and Collaborators
Phage Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: 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: March 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Phage Pharmaceuticals, Inc.:
Human growth hormone
idiopathic short stature
short stature

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014