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Sponsored by: |
Daiichi Sankyo Inc. |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00613431 |
The main purposes of this study are to assess the safety and measure the pharmacokinetics of CS-8080 in healthy volunteers.
Condition | Intervention | Phase |
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Healthy |
Drug: CS8080 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Placebo-Controlled, Single Ascending Dose Study To Assess The Safety, Tolerability and Pharmacokinetics Of CS-8080 In Healthy Volunteers |
Estimated Enrollment: | 72 |
Study Start Date: | January 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
6 dose groups, 9 subjects on active, 3 subjects on placebo in each group
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Drug: CS8080
CS-8080 tablets will be administered once daily at doses of 1, 3, 10, 20, 50 and 100 mg.
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2: Placebo Comparator
3 subjects on placebo in each group
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Drug: Placebo
Some subjects will receive matching placebo instead of CS-8080.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria Healthy men and/or women, aged 18 to 45 years inclusive.
Exclusion Criteria
Responsible Party: | Daiichi Sankyo Pharma Development ( Karen Brown Ph.D. Associate Director, Experimental Medicine ) |
Study ID Numbers: | CS8080-A-U101, CS8080-A-U101 |
Study First Received: | January 31, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00613431 |
Health Authority: | United States: Food and Drug Administration |
pharmacodynamics |
Healthy |