Healthy Subjects Clinical Trial
Official title:
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
NCT number | NCT01251731 |
Other study ID # | E5501-A001-006 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | November 30, 2010 |
Last updated | April 4, 2012 |
Start date | July 2010 |
Verified date | April 2012 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 45 Years |
Eligibility |
Key Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Parexel International, Early Phase Clinical Unit | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • To compare the single-dose pharmacokinetics (PK), as measured by AUCinf of three doses of E5501 (10, 40, and 80 mg) in healthy Japanese and Chinese subjects relative to healthy Caucasian subjects | up to 96 hours post-dose | No | |
Primary | • To compare the multiple-dose steady-state PK, as measured by AUCss, of E5501 in healthy Japanese and Chinese subjects relative to Caucasian subjects | up to 96 hours after dosing on Day 7 or up to 240 hours after the first drug dosing | No | |
Primary | • To compare the multiple-dose pharmacodynamic (PD) response as measured by platelet counts for E5501 in healthy Japanese and Chinese subjects relative to Caucasian subjects | through Day 21 for each SD Treatment Period and through Day 30 for the MD Treatment Period | No | |
Primary | • To compare the single-dose pharmacokinetics (PK), as measured by Cmax of three doses of E5501 (10, 40, and 80 mg) in healthy Japanese and Chinese subjects relative to healthy Caucasian subjects | up to 96 hours post-dose | No | |
Secondary | To evaluate single-dose linearity of 10, 40 and 80mg E5501 in healthy Japanese, Chinese, and Caucasian subjects | from Day 1 SD Treatment Period 1 through Day 30 MD Treatment Period 4 | No | |
Secondary | To characterize PK/PD relationships between E5501 exposure and platelet count response in healthy Japanese, Chinese, and Caucasian subjects | from Day 1 SD Treatment Period 1through Day 30 MD Treatment Period 4 | No |
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