Status:
COMPLETED
Single and Multiple Dose Asian Bridging Study
Lead Sponsor:
Eisai Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key
- Normal healthy adult males and females (age 20-45 years)
- Body Mass Index greater than or equal to 18 and less than or equal to 29 at the time of screening
- Japanese and Chinese subjects must be born in their respective countries of origin and have parents and grandparents of Japanese or Chinese descent, respectively
- Japanese subjects must have lived outside of Japan for no more than 5 years; Chinese subjects must have lived outside of China for no more than 10 years
- In addition to mainland China, Chinese subjects may be from Taiwan, Hong Kong, or Mongolia
- Japanese and Chinese subjects must not have significantly changes their lifestyle with regard to diet; i.e., their diet must not have significantly changed since leaving China or Japan
- Platelet count between 150,000 and 300,000/mm3
- Key
Exclusion
- Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of the study drug
- Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history, e.g., history of splenectomy
- History of venous or arterial thrombotic disease or other hypercoagulable state
- Hemoglobin level less than 12.0 g/dL
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01251731
Start Date
July 1 2010
Last Update
April 6 2012
Active Locations (1)
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1
Parexel International, Early Phase Clinical Unit
Los Angeles, California, United States