Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
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Purpose
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%.
| Condition | Intervention | Phase |
|---|---|---|
|
Purpura, Thrombocytopenic, Idiopathic Acute Idiopathic Thrombocytopenic Purpura Chronic Thrombocytopenia |
Drug: E5501 40 mg 2 x 20-mg tablets, orally, fasted Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food Drug: E5501 40mg 2 x 20-mg tablets, orally, fasted Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 84 |
| Study Start Date: | February 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment A |
Drug: E5501 40 mg 2 x 20-mg tablets, orally, fasted
single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fasted condition
|
| Experimental: Treatment B |
Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food
single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition
|
| Experimental: Treatment C |
Drug: E5501 40mg 2 x 20-mg tablets, orally, fasted
single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fasted condition
|
| Experimental: Treatment D |
Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food
single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fed condition
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01327872 History of Changes |
| Other Study ID Numbers: | E5501-G000-010 |
| Study First Received: | March 30, 2011 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Netherlands: Medicines Evaluation Board (MEB) |
Keywords provided by Eisai Inc.:
|
Idiopathic Thrombocytopenia Purpura(ITP) Acute and Chronic Thrombocytopenia Associated with Chronic Liver Disease TLD |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes |
Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases |
ClinicalTrials.gov processed this record on June 18, 2013