NCT01359488

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

1.3 years

First QC Date

May 13, 2011

Last Update Submit

July 19, 2012

Conditions

Growth Hormone Deficiency

Keywords

Growth Hormone DeficiencyrhGHhGHVersartisAGHDHormonesHormone substituteEndocrin System diseaseBone diseaseBone disease, developmentalBone diseasesMusculoskeletal diseasesBone diseases, endocrineMetabolism diseasesHypopituitarismPituitary diseaseHypothalmic diseaseBrain diseaseGrowth Hormone Releasing HormoneHormone replacement therapyIGF-IIGFBP-3

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of single dose of VRS-317

    This study will evaluate the differences between VRS-317 dose levels and placebo for adverse events. Summaries will be provided for each dose cohort and for the combined dose cohorts including the number of patients with adverse events. All subjects who receive at least one dose of VRS-317 or placebo will be included in the safety analysis. Summaries of all adverse events (AEs)and serious adverse events (SAEs)will be classified according to severity and relationship to study drug.

    30 days

Secondary Outcomes (1)

  • Determine the pharmacokinetic (PK) profile of VRS-317 administered SC

    30 days

Study Arms (5)

VRS-317 Safety Arm 1

EXPERIMENTAL

VRS-317 Single injection SC of dose level 1 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume

Drug: VRS-317

VRS-317 Safety Arm 2

EXPERIMENTAL

VRS-317 Single injection SC of dose level 2 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume

Drug: VRS-317

VRS-317 Safety Arm 3

EXPERIMENTAL

VRS-317 Single injection SC of dose level 3 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume

Drug: VRS-317

VRS-317 Safety Arm 4

EXPERIMENTAL

VRS-317 Two injections SC of dose level 4 (based on 90 kg patient) Placebo Two SC injection Dose matched to treatment volume

Drug: VRS-317

VRS-317 Safety Arm 5

EXPERIMENTAL

VRS-317 Two injections SC of dose level 5 (based on 90 kg patient) Placebo Two SC injections Dose Volume matched to active treatment volume

Drug: VRS-317

Interventions

VRS-317DRUG

VRS-317 Single Dose

Also known as: Growth Hormone Deficiency, rhGH, hGH, AGHD, IGF-I, IGFBP-3, Hormones, Hormone Substitutes, Endocrine System Disease, Bone Diseases, Bone Diseases, Developmental, Musculoskeletal Diseases, Bone Disease, Endocrine, Metabolic Diseases, Hypopituitarism, Pituitary Disease, Hypothalmic Disease, Growth Hormone Replacement Therapy, Hormone Replacement Therapy, Growth Hormone Releasing Hormone, Versartis, VRS317
VRS-317 Safety Arm 1

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Yuen KC, Conway GS, Popovic V, Merriam GR, Bailey T, Hamrahian AH, Biller BM, Kipnes M, Moore JA, Humphriss E, Bright GM, Cleland JL. A long-acting human growth hormone with delayed clearance (VRS-317): results of a double-blind, placebo-controlled, single ascending dose study in growth hormone-deficient adults. J Clin Endocrinol Metab. 2013 Jun;98(6):2595-603. doi: 10.1210/jc.2013-1437. Epub 2013 Apr 12.

    PMID: 23585663DERIVED

MeSH Terms

Conditions

Dwarfism, PituitaryBone DiseasesBone Diseases, DevelopmentalMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesBrain Diseases

Interventions

Insulin-Like Growth Factor IInsulin-Like Growth Factor Binding Protein 3HormonesHormones, Hormone Substitutes, and Hormone AntagonistsGrowth and DevelopmentNational Institute of Arthritis and Musculoskeletal and Skin Diseases (U.S.)Hormone Replacement TherapyGrowth Hormone-Releasing Hormone

Condition Hierarchy (Ancestors)

DwarfismHypothalamic DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological FactorsInsulin-Like Growth Factor Binding ProteinsCarrier ProteinsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPhysiological PhenomenaNational Institutes of Health (U.S.)Academies and InstitutesOrganizationsHealth Care Economics and OrganizationsUnited States Public Health ServiceUnited States Dept. of Health and Human ServicesUnited States Government AgenciesFederal GovernmentGovernmentDrug TherapyTherapeuticsPituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesNeuropeptidesNerve Tissue Proteins

Study Officials

  • Mark Kipnes, MD

    Diabetes and Glandular Disease Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 24, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

US(1)