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Sponsored by: |
Halozyme Therapeutics |
---|---|
Information provided by: | Halozyme Therapeutics |
ClinicalTrials.gov Identifier: | NCT00807963 |
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.
Condition | Intervention | Phase |
---|---|---|
Risk Factors for or a Diagnosis of Osteoporosis |
Drug: rHuPH20 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Subject), Single Group Assignment, Pharmacokinetics Study |
Official Title: | Phase I, Open-Label, Pharmacokinetic, Safety and Tolerability Study of Subcutaneously Administered Bisphosphonate With Recombinant Human Hyaluronidase (rHuPH20) vs Bisphosphonate |
Estimated Enrollment: | 72 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Healthcare Discoveries, LLC/ICON Development Solutions | Recruiting |
San Antonio, Texas, United States, 78209 | |
Contact: Cassandra Cheatham, BS 210-798-5117 Cassandra.Cheatham@iconplc.com | |
Principal Investigator: Emanuel P DeNoia, MD |
Principal Investigator: | Emanuel P DeNoia, MD | Healthcare Discoveries, LLC/ICON |
Responsible Party: | Halozyme Therapeutics ( Samuel S. Dychter, M.D. ) |
Study ID Numbers: | HZ2-08-02 |
Study First Received: | December 11, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00807963 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetics rHuPH20 |
Diphosphonates Musculoskeletal Diseases Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases |
Diphosphonates Musculoskeletal Diseases Physiological Effects of Drugs Osteoporosis |
Bone Density Conservation Agents Bone Diseases, Metabolic Bone Diseases Pharmacologic Actions |