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NCT00807963 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone
A Phase 1 study of Risk Factors for or a Diagnosis of Osteoporosis, sponsored by Halozyme Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00807963 is a Phase 1 study of Risk Factors for or a Diagnosis of Osteoporosis that has completed, run by Halozyme Therapeutics. The registered enrollment target is 31 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00807963, a Phase 1 study of Risk Factors for or a Diagnosis of Osteoporosis, has completed, sponsored by Halozyme Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG rHuPH20
- DRUG zoledronic acid
Study Locations (1)
Texas
- Healthcare Discoveries, LLC/ICON Development Solutions - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-09-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00807963
The ClinicalTrials.gov registry entry for NCT00807963 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Risk Factors for or a Diagnosis of Osteoporosis appearing as the primary indexed condition, and to 2 interventions - of which rHuPH20 is the first listed.
NCT00807963 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00807963 about?
NCT00807963 is a clinical study titled "Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone". 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 ...
What is the current status of trial NCT00807963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2008-12. Estimated completion is 2009-09-21.
What conditions does trial NCT00807963 study?
This clinical trial studies the following conditions: Risk Factors for or a Diagnosis of Osteoporosis.
What interventions are being tested in trial NCT00807963?
The interventions under investigation include: rHuPH20 (DRUG), zoledronic acid (DRUG).
Who is sponsoring clinical trial NCT00807963?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00807963 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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