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Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects

Primary Purpose

Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura, Chronic Thrombocytopenia

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

E5501 40 mg 2 x 20-mg tablets, orally, fasted

E5501 40 mg 2 x 20-mg tablets, orally, with food

E5501 40mg 2 x 20-mg tablets, orally, fasted

E5501 40 mg 2 x 20-mg tablets, orally, with food

About this trial

This is an interventional treatment trial for Purpura, Thrombocytopenic, Idiopathic focused on measuring Idiopathic Thrombocytopenia Purpura(ITP), Acute and Chronic Thrombocytopenia Associated with Chronic Liver Disease, TLD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

PRA Early Development Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Treatment A

Treatment B

Treatment C

Treatment D

Arm Description

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditions

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01327872

First Posted

March 30, 2011

Last Updated

March 8, 2012

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01327872

Brief Title

Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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%.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura, Chronic Thrombocytopenia

Keywords

Idiopathic Thrombocytopenia Purpura(ITP), Acute and Chronic Thrombocytopenia Associated with Chronic Liver Disease, TLD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Experimental

Arm Title

Treatment B

Arm Type

Experimental

Arm Title

Treatment C

Arm Type

Experimental

Arm Title

Treatment D

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

E5501 40 mg 2 x 20-mg tablets, orally, fasted

Intervention Description

single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fasted condition

Intervention Type

Drug

Intervention Name(s)

E5501 40 mg 2 x 20-mg tablets, orally, with food

Intervention Description

single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition

Intervention Type

Drug

Intervention Name(s)

E5501 40mg 2 x 20-mg tablets, orally, fasted

Intervention Description

single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fasted condition

Intervention Type

Drug

Intervention Name(s)

E5501 40 mg 2 x 20-mg tablets, orally, with food

Intervention Description

single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fed condition

Primary Outcome Measure Information:

Title

Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditions

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franklin Johnson

Organizational Affiliation

Eisai Inc.

Official's Role

Study Director

Facility Information:

Facility Name

PRA Early Development Services

City

Zuidlaren

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects

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