VRS-317 in Adult Subjects With Growth Hormone Deficiency

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Versartis Inc.
• Treatments: Growth Hormone-Releasing Hormone; Hormones

Criteria

Inclusion Criteria:

1. Age 25 to 65 years

2. Negative serum pregnancy test for females of childbearing potential

3. Documented confirmation (medical history) of GHD during adulthood by one or more GH stimulation test

4. If taking hormone replacement therapy other than rhGH, patient must be on a stable course of treatment for 2 months prior to enrollment

5. Pituitary disorder associated with GHD has been clinically stable for at least 6 months

6. Currently receiving daily recombinant human growth hormone (rhGH) injections for treatment of GHD for a minimum of 28 days

7. Willing and able to give informed consent

8. 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:

1. 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)

2. 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

3. Subjects with untreated adrenal insufficiency.

4. Free thyroxine below normal reference range or TSH above normal reference range

5. Current use of oral or inhaled steroids except for physiological maintenance doses of oral glucocorticoids in patients with multiple pituitary hormone deficiencies

6. Women using oral estrogens, including birth control pills, during study (transdermal estrogen patches are allowed)

7. Current significant cardiovascular, cerebrovascular, pulmonary, neurological (not related to GHD), renal or hepatobillary disease

8. Presence of retinopathy or papillaedema

9. Documented history of persistent (unresolved without medical intervention) or recurring migraines, edema, arthralgia (not related to osteoarthritis), or nausea

10. History of drug or alcohol abuse.

11. Must not have documented prior history of HIV, HBV or HCV infection(testing not required)

12. Prior history of cancer excluding adequately treated non-melanoma skin cancers or adequately treated in situ carcinoma of the cervix

13. Women who are pregnant or breastfeeding

14. Unwilling to use two effective birth control methods until Day 60 of Treatment Phase

15. 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)

16. Treatment with an investigational drug within past 30 days prior to screening

17. Unable to comply with requirements of this study.