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VRS-317 in Adult Subjects With Growth Hormone Deficiency

NCT01359488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-07-23

No results posted yet for this study

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

Conditions

  • Growth Hormone Deficiency

Interventions

DRUG

VRS-317

VRS-317 Single Dose

DRUG

VRS-317

VRS-317 Single Dose

DRUG

VRS-317

VRS-317 Single Dose

DRUG

VRS-317

VRS-317 Single dose

DRUG

VRS-317

VRS-317 Single dose

Sponsors & Collaborators

  • Versartis Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Kipnes, MD · Diabetes and Glandular Disease Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01359488 on ClinicalTrials.gov