Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01437384
• Date of registration: 19/09/2011
• Prospective Registration: No
• Primary sponsor: Eisai Inc.
• Public title: Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine.
• Scientific title: An Open-label, Single-sequence, Four-treatment Period Study to Evaluate Pharmacokinetic and Pharmacodynamic Interactions Between E5501 and Verapamil, and E5501 and Cyclosporine, Known P-glycoprotein Inhibitors in Healthy Subjects
• Date of first enrolment: September 2011
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01437384
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Gina Pastino
• Affiliation: Eisai Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura (ITP)

Intervention(s)

Drug: E5501

Primary Outcome(s)

Plasma concentrations of E5501 [Time Frame: Periodically over the course of Days 1-11]

Secondary Outcome(s)

Platelet counts [Time Frame: Periodically over the course of Days 1-34]

Secondary ID(s)

E5501-A001-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors