A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501
Study Details
Study Description
Brief Summary
This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 10-mg dose of E5501 2G tablet
|
Drug: 10-mg dose of E5501 2G tablet
Treatment A: Single 10-mg dose of E5501 2G tablet
|
| Experimental: 10-mg dose of E5501 cyclodextrin oral solution
|
Drug: 10-mg dose of E5501 cyclodextrin oral solution
Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution
|
| Experimental: 10-mg dose of E5501-P21% powder
|
Drug: 10-mg dose of E5501-P21% powder
Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension
|
| Experimental: 10-mg dose of E5501 lipid-based oral
|
Drug: 10-mg dose of E5501 lipid-based oral
Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension
|
Outcome Measures
Primary Outcome Measures
- Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax [133 days]
Secondary Outcome Measures
- Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food [133 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adult men and women (age ≥ 18 to ≤ 55 years)
-
Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
-
Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
-
Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.
In addition, other standard criteria for healthy subjects will be used.
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 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 event or illness in the subject's medical history, e.g., history of splenectomy.
-
History of arterial or venous thrombosis, including partial or complete thrombosis (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.
In addition, other standard criteria for healthy subjects will be used.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Quotient | Nottingham | United Kingdom |
Sponsors and Collaborators
- Eisai Inc.
Investigators
- Study Director: Bhaskar Rege, Eisai Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E5501-G000-012