VRS-317 in Adult Subjects With Growth Hormone Deficiency
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
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