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

March 9, 2012 updated by: Phage Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77402
        • Novum Pharmaceutical Research Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pharmacokinetics

Secondary Outcome Measures

Outcome Measure
serum concentrations of insulin-like growth factor-1 (IGF-1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phage Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYN-05-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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