Single and Multiple Dose Asian Bridging Study
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2010 |
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Single-Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of 10, 40, and 80 mg E5501 Followed by a Selected Dose for Multiple Dosing Administered to Healthy Japanese, Chinese, and Caucasian Subjects
The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK),
pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a
selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.
This study will evaluate the single-dose (SD) pharmacokinetics (PK), pharmacodynamics (PD),
safety, and tolerability of oral doses of 10, 40, and 80 mg E5501 administered to 36 healthy
male and female Japanese, Chinese, and Caucasian subjects. For the SD Treatment Period, 12
subjects from each ethnic group will be randomized to receive single doses of 10, 40, or 80
mg E5501 or matching placebo each treatment period. Each subject will be allocated to a
treatment sequence to be dosed with either placebo for the three periods or dosed with each
of the three different doses in the three periods. For the Multiple-Dose (MD) Treatment
Period the 12 subjects in each ethnic group will be further randomized as active (dose level
to be determined from the SD Treatment Period or placebo in a 3:1 ratio.
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