Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.
Lead Sponsor:
Eisai Inc.
Conditions:
Idiopathic Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment ...
Eligibility Criteria
Inclusion
- Inclusion:
- Healthy adult men and women (age 18 to 55 years)
- Body mass index greater than or equal to 18kg/m2 and less than or equal to 32kg/m2 at the time of Screening and at each Baseline
- Platelet count between 120x109/L and 300x109/L at Baseline
- Women of childbearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the treatment phase of the study
- 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
- 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 event or illness in the subject's medical history, e.g., history of splenectomy
- History of arterial or venous thrombosis, including partial or complete thromboses (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
- Hemoglobin less than the lower limit of normal levels (women, 7.1 mmol/L; men, 8.1 mmol/L) In addition, other standard criteria for healthy volunteers will be used.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01437384
Start Date
September 1 2011
Last Update
May 21 2012
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283