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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03885882




Registration number
NCT03885882
Ethics application status
Date submitted
6/03/2019
Date registered
22/03/2019

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
E0302-J064-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - E0302 SR1
Treatment: Drugs - E0302 SR3
Treatment: Drugs - E0302 SR2
Treatment: Drugs - E0302 IR

Experimental: Cohort 1: E0302 Sustained Release (SR1) 1500 mcg - Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.

Experimental: Cohort 2: E0302 Sustained Release (SR3) 1500 mcg - Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.

Experimental: Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg - 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.

Experimental: Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg - 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.


Treatment: Drugs: E0302 SR1
E0302 SR1, oral tablet.

Treatment: Drugs: E0302 SR3
E0302 SR3, oral tablet.

Treatment: Drugs: E0302 SR2
E0302 SR2, oral tablet.

Treatment: Drugs: E0302 IR
E0302 IR, oral tablet.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR
Timepoint [1] 0 0
Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose
Primary outcome [2] 0 0
AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration
Timepoint [2] 0 0
Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
Primary outcome [3] 0 0
AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time
Timepoint [3] 0 0
Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
Primary outcome [4] 0 0
Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
Timepoint [4] 0 0
Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days
Primary outcome [5] 0 0
Number of Participants With Abnormal Clinical Laboratory Values
Timepoint [5] 0 0
Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10
Primary outcome [6] 0 0
Number of Participants With Abnormal Vital Sign Values
Timepoint [6] 0 0
Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
Primary outcome [7] 0 0
Number of Participants With Abnormal 12-lead Electrocardiogram Values
Timepoint [7] 0 0
Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18

Eligibility
Key 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
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from this study:

1. 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
2. Subjects who contravene the restrictions on concomitant medications, food and beverages
3. Currently enrolled in another clinical study or used any investigational drug or device within 3 months preceding informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/06/2019
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03885882