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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00788294 |
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
Condition | Intervention | Phase |
---|---|---|
Healthy Volunteers |
Biological: tanezumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Bio-availability Study |
Official Title: | Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study |
Estimated Enrollment: | 72 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
10 mg IV: Active Comparator |
Biological: tanezumab
Drug solution given intravenously only once at dose of 10 mg
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5 mg SC: Active Comparator |
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 5 mg.
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10 mg SC: Active Comparator |
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 10 mg.
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19 mg SC: Active Comparator |
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 19 mg.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, California | |
Pfizer Investigational Site | Recruiting |
Cypress, California, United States, 90630 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4091013 |
Study First Received: | November 7, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00788294 |
Health Authority: | United States: Food and Drug Administration |
Pharmacokinetics, tanezumab, subcutaneous, bioavailability, intravenous, healthy volunteers, Japanese subjects. |
Healthy |