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| Sponsor: | Daiichi Sankyo Inc. |
|---|---|
| Information provided by: | Daiichi Sankyo Inc. |
| ClinicalTrials.gov Identifier: | NCT00796575 |
Purpose
The main purposes of this study are to assess the safety and measure the pharmacokinetics and pharmacodynamics of CS-8080 in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: CS-8080 Drug: placebo tablets |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | A Randomized, Placebo-Controlled, Multiple Ascending Dose Study To Assess The Safety, Pharmacokinetics and Pharmacodynamics Of CS-8080 In Healthy Volunteers |
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CS-8080: Experimental
3 mg CS-8080, 10mg CS-8080, 20 mg CS-8080
|
Drug: CS-8080
CS-8080 1mg tablets, 3 tablets administered 1 times per day
Drug: CS-8080
CS-8080 5 mg tablets, 2 tablets administered 1 times per day
Drug: CS-8080
CS-8080 5 mg tablets, 4 tablets administered 1 times per day
|
|
placebo: Placebo Comparator
placebo
|
Drug: placebo tablets
placebo tablets matching active
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Daiichi Sankyo ( Director Experimental Medicine ) |
| Study ID Numbers: | CS8080-A-U102 |
| Study First Received: | November 21, 2008 |
| Last Updated: | December 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00796575 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
multiple ascending dose healthy volunteers pharmacokinetics pharmacodynamics |