A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501
This study has been completed.
Sponsor:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01549054
First received: January 31, 2012
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Idiopathic Thrombocytopenic Purpura |
Drug: 10-mg dose of E5501 2G tablet Drug: 10-mg dose of E5501 cyclodextrin oral solution Drug: 10-mg dose of E5501-P21% powder Drug: 10-mg dose of E5501 lipid-based oral |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax [ Time Frame: 133 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food [ Time Frame: 133 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 More Information
No publications provided
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01549054 History of Changes |
| Other Study ID Numbers: | E5501-G000-012 |
| Study First Received: | January 31, 2012 |
| Last Updated: | August 13, 2012 |
| Health Authority: | European Union: European Medicines Agency |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations |
Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases |
ClinicalTrials.gov processed this record on May 22, 2013