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| Descriptive Information Fields | |||||
| Brief Title † | A Study of the Safety of PAZ-417 in Healthy Elderly Adults | ||||
| Official Title † | An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Elderly Subjects | ||||
| Brief Summary | This is study to determine the safety of PAZ-417 in healthy adults over 65. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | safety as determined by adverse events, ECGs, vitals signs, and laboratory test results [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | Drug distribution in the blood [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Condition † | Healthy | ||||
| Intervention † | Drug: PAZ-417 | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | April 2008 | ||||
| Completion Date | September 2008 | ||||
| Eligibility Criteria † | Inclusion:
Exclusion
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00663065 | ||||
| Organization ID | 3186A1-1102 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Wyeth | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Wyeth | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 17, 2008 | ||||
| Last Updated Date | April 19, 2008 | ||||