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Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone

NCT00807963 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-08-15

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated concentration (MTC) of bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20 to bisphosphonate alone.

Conditions

  • Risk Factors for or a Diagnosis of Osteoporosis

Interventions

DRUG

rHuPH20

recombinant human hyaluronidase PH20 injection

DRUG

zoledronic acid

subcutaneous injection

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Emanuel P DeNoia, MD · Healthcare Discoveries, LLC/ICON

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-09-21
Completion
2009-09-21

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 NCT00807963 on ClinicalTrials.gov