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Sponsored by: |
Targacept Inc. |
Information provided by: | Targacept Inc. |
ClinicalTrials.gov Identifier: | NCT00583544 |
Targacept, Inc. is studying TC-2216 for a potential role in the treatment of central nervous system (CNS) neurobiological disorders in anticipation of seeking an indication in depression and/or anxiety.
Condition | Intervention | Phase |
Healthy |
Drug: TC-2216 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind, Sequential, Ascending Single Dose, Placebo-Controlled Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Study of TC-2216 in Healthy Young Male Volunteers. |
Estimated Enrollment: | 72 |
Study Start Date: | January 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
Drug: TC-2216
Multiple ascending dose groups will be explored.
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2: Experimental |
Drug: TC-2216
Multiple ascending dose groups will be explored.
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Related Info 
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Responsible Party: | Targacept, Inc ( Geoffrey Dunbar, Vice President, CDRA ) |
Study ID Numbers: | TC-2216-232-CLP-001 |
First Received: | December 20, 2007 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00583544 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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