VRS-317 in Adult Subjects With Growth Hormone Deficiency

Completed · Phase 1

Conditions studied: Growth Hormone Deficiency

In brief

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

Key facts

Study ID

NCT01359488

Run by

Versartis Inc.

People needed

50

Starts

2011-03-01

Expected to finish

2012-07-01

Last updated by the study team

2012-07-23

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 25 to 65 years
• Negative serum pregnancy test for females of childbearing potential
• Documented confirmation (medical history) of GHD during adulthood by one or more GH stimulation test
• If taking hormone replacement therapy other than rhGH, patient must be on a stable course of treatment for 2 months prior to enrollment
• Pituitary disorder associated with GHD has been clinically stable for at least 6 months
• Currently receiving daily recombinant human growth hormone (rhGH) injections for treatment of GHD for a minimum of 28 days
• Willing and able to give informed consent
• 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

You may not qualify if…

• 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)
• 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 ≥ 6.5% at screening
• Subjects with untreated adrenal insufficiency.
• Free thyroxine below normal reference range or TSH above normal reference range
• Current use of oral or inhaled steroids except for physiological maintenance doses of oral glucocorticoids in patients with multiple pituitary hormone deficiencies
• Women using oral estrogens, including birth control pills, during study (transdermal estrogen patches are allowed)
• Current significant cardiovascular, cerebrovascular, pulmonary, neurological (not related to GHD), renal or hepatobillary disease
• Presence of retinopathy or papillaedema
• Documented history of persistent (unresolved without medical intervention) or recurring migraines, edema, arthralgia (not related to osteoarthritis), or nausea
• History of drug or alcohol abuse.
• Must not have documented prior history of HIV, HBV or HCV infection(testing not required)
• Prior history of cancer excluding adequately treated non-melanoma skin cancers or adequately treated in situ carcinoma of the cervix
• Women who are pregnant or breastfeeding
• Unwilling to use two effective birth control methods until Day 60 of Treatment Phase
• Pre-existing antibodies to human growth hormone at time of screening (screening samples must be below pre-specified cut-off for positive anti-hGH antibody titer)
• Treatment with an investigational drug within past 30 days prior to screening
• Unable to comply with requirements of this study.

Where it is running

• Diabetes and Glandular Disease Clinic — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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