Back to resultsA Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants
Primary Purpose
Healthy Subjects
Status
Completed
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
E0302 SR1
E0302 SR3
E0302 SR2
E0302 IR
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Subjects focused on measuring E0302, Healthy Subjects, E0302 SR Tablet, E0302 IR Tablet
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
1. Body mass index (BMI) of 18 to 30 kilogram per meter square [kg/m2], inclusive at Screening
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline
- Subjects who contravene the restrictions on concomitant medications, food and beverages
- Currently enrolled in another clinical study or used any investigational drug or device within 3 months preceding informed consent
Sites / Locations
- Auckland Clinical Studies
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1: E0302 Sustained Release (SR1) 1500 mcg
Cohort 2: E0302 Sustained Release (SR3) 1500 mcg
Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg
Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg
Arm Description
Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.
Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.
Participants will receive a single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 1 in Treatment Period 1 followed by single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
Participants will receive a single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 1 in Treatment Period 1 followed by single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
Outcomes
Primary Outcome Measures
Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR
AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration
AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time
Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
Number of Participants With Abnormal Clinical Laboratory Values
Number of Participants With Abnormal Vital Sign Values
Number of Participants With Abnormal 12-lead Electrocardiogram Values
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03885882
Brief Title
A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants
Official Title
An Open-Label, Randomized, Single Dose Study to Evaluate the Pharmacokinetics of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 13, 2019 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
Keywords
E0302, Healthy Subjects, E0302 SR Tablet, E0302 IR Tablet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Cohort 1 and Cohort 2 will receive treatment as parallel assignment. Cohort 3 will receive treatment in cross-over manner.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: E0302 Sustained Release (SR1) 1500 mcg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.
Arm Title
Cohort 2: E0302 Sustained Release (SR3) 1500 mcg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.
Arm Title
Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 1 in Treatment Period 1 followed by single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
Arm Title
Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of E0302 IR 500 mcg tablet (Treatment B) on Day 1 in Treatment Period 1 followed by single dose of E0302 SR2 1500 mcg tablet (Treatment A) on Day 7 in Treatment Period 2. A wash-out phase of at least 5 days will be maintained between the treatment periods.
Intervention Type
Drug
Intervention Name(s)
E0302 SR1
Intervention Description
E0302 SR1, oral tablet.
Intervention Type
Drug
Intervention Name(s)
E0302 SR3
Intervention Description
E0302 SR3, oral tablet.
Intervention Type
Drug
Intervention Name(s)
E0302 SR2
Intervention Description
E0302 SR2, oral tablet.
Intervention Type
Drug
Intervention Name(s)
E0302 IR
Intervention Description
E0302 IR, oral tablet.
Primary Outcome Measure Information:
Title
Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR
Time Frame
Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose
Title
AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration
Time Frame
Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
Title
AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time
Time Frame
Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
Title
Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
Time Frame
Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days
Title
Number of Participants With Abnormal Clinical Laboratory Values
Time Frame
Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10
Title
Number of Participants With Abnormal Vital Sign Values
Time Frame
Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
Title
Number of Participants With Abnormal 12-lead Electrocardiogram Values
Time Frame
Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study:
1. Body mass index (BMI) of 18 to 30 kilogram per meter square [kg/m2], inclusive at Screening
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline
Subjects who contravene the restrictions on concomitant medications, food and beverages
Currently enrolled in another clinical study or used any investigational drug or device within 3 months preceding informed consent
Facility Information:
Facility Name
Auckland Clinical Studies
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Learn more about this trial
A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants
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