Overview

Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a reduction in either the within or between subject variability (coefficient of variation [CV]%) of approximately 35%.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eisai Inc.
Criteria
Inclusion criteria:

- Normal healthy male or female subjects age greater than or equal to 18 years and less
than or equal to 55 years

- Body mass index greater than or equal to 18 and less than or equal to 32kg/m2 at
Screening

- Platelet count greater than or equal to 120x109/L and less than or equal to 250x109/L

- Women of childbearing potential must agree to use a highly effective method of
contraception, other than estrogen-based hormonal contraceptives, during the
Randomization Phase of the study

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 PK
of the study drug

- Agents associated with thrombotic events (including oral contraceptives) must be
discontinued within 30 days of first study drug administration

- 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 hypercoaguable state

- Hemoglobin less than lower limit of normal (LLN) levels (females 7.1 mmol/L, males 8.1
mmol/L