- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01327872
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
March 8, 2012 updated by: Eisai Inc.
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
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%.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study.
The PK and PK/PD relationship of AKR-501 will also be studied.
Approximately 65 eligible patients will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either AKR-501 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively.
Each AKR-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients.
All study patients will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) AKR-501 pharmacokinetics while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (Day 42).
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zuidlaren, Netherlands
- PRA Early Development Services
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment B
|
single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition
single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fed condition
|
Experimental: Treatment C
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single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fasted condition
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Experimental: Treatment A
|
single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fasted condition
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Experimental: Treatment D
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single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition
single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fed condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditions
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Franklin Johnson, Eisai Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
March 30, 2011
First Submitted That Met QC Criteria
March 31, 2011
First Posted (Estimate)
April 4, 2011
Study Record Updates
Last Update Posted (Estimate)
March 9, 2012
Last Update Submitted That Met QC Criteria
March 8, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
Other Study ID Numbers
- E5501-G000-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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