VRS-317 in Adult Subjects With Growth Hormone Deficiency (NCT01359488) | Clinical Trial Compass
CompletedPhase 1
VRS-317 in Adult Subjects With Growth Hormone Deficiency
United States50 participantsStarted 2011-03
Plain-language summary
The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients.
* Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase)
* Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3) will be determined by standard model independent methods based on the plasma concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg, AUC0-inf, and t1/2.
* The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range (for appropriate age/gender) for IGF-I levels in adult patients for up to one month after administration of a single dose
Who can participate
Age range25 Years ā 65 Years
SexALL
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Inclusion criteria
ā. Age 25 to 65 years
ā. Negative serum pregnancy test for females of childbearing potential
ā. Documented confirmation (medical history) of GHD during adulthood by one or more GH stimulation test
ā. If taking hormone replacement therapy other than rhGH, patient must be on a stable course of treatment for 2 months prior to enrollment
ā. Pituitary disorder associated with GHD has been clinically stable for at least 6 months
ā. Currently receiving daily recombinant human growth hormone (rhGH) injections for treatment of GHD for a minimum of 28 days
ā. Willing and able to give informed consent
ā. Within one year from enrollment, normal result from screening including: mammogram (women), pap smear (women over 25), Men over 50 years old: digital rectal exam
Exclusion criteria
ā. Subjects who have received systemic treatment for any bacterial, viral or fungal infection within 30 days of the first study drug dosing (prophylactic acyclovir for HSV is permitted)
ā. Subjects with documented history of diabetes mellitus or inadequate glucose control as defined by fasting plasma glucose level of greater than 126 mg/dL (7 mM) or HbA1c of ā„ 6.5% at screening
ā. Subjects with untreated adrenal insufficiency.
ā. Free thyroxine below normal reference range or TSH above normal reference range
ā. Current use of oral or inhaled steroids except for physiological maintenance doses of oral glucocorticoids in patients with multiple pituitary hormone deficiencies
ā. Women using oral estrogens, including birth control pills, during study (transdermal estrogen patches are allowed)
ā. Current significant cardiovascular, cerebrovascular, pulmonary, neurological (not related to GHD), renal or hepatobillary disease