Purpura, Thrombocytopenic, Idiopathic Clinical Trial
Official title:
A Randomized, Open-Label, 4-Group, 2-Period Replicate Design Study to Evaluate Within- and Between-Subject Variability in Exposure of Two Lots of E5501 20 mg Tablets, Administered as Single Doses of 40 mg, in the Fasted and Fed Conditions to Healthy Subjects
Verified date | March 2012 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medicines Evaluation Board (MEB) |
Study type | Interventional |
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%.
Status | Completed |
Enrollment | 84 |
Est. completion date | June 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | PRA Early Development Services | Zuidlaren |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditions | 8 weeks | No | |
Secondary | To evaluate the comparison of the overall effect of food on the bioavailability of E5501 relative to the fasted condition as measured by AUC(0-inf) and Cmax | 8 weeks | No |
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