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Tracking Information | |||||
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First Received Date † | January 21, 2009 | ||||
Last Updated Date | April 24, 2009 | ||||
Start Date † | January 2009 | ||||
Current Primary Outcome Measures † |
Safety as measured by the number of adverse events and serious adverse events. Tolerability as measured by occurrence of dose limiting toxicities. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00827489 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Pharmacokinetic and pharmacodynamic parameters. [ Time Frame: 5 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Study Evaluating HTC-867 in Healthy Young and Elderly Subjects | ||||
Official Title † | Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTC-867 Administered Orally to Healthy Subjects | ||||
Brief Summary | The purpose of this study is to assess the safety and tolerability of ascending single oral doses of HTC-867 in healthy young and elderly subjects. This study will also evaluate the way the drug enters and leaves the blood and tissues over time and how the drug acts on and in the body in a fasted and fed state. |
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Detailed Description | |||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study | ||||
Condition † | Healthy Subjects | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 72 | ||||
Estimated Completion Date | June 2009 | ||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion:
Exclusion:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00827489 | ||||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||
Secondary IDs †† | |||||
Study Sponsor † | Wyeth | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Wyeth | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |