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.
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.
