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

December 23, 2019 updated by: Eisai Co., Ltd.

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

To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • New Zealand
      • Auckland, New Zealand
        • Auckland Clinical Studies

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 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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 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: 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.
Drug: E0302 SR1
E0302 SR1, oral tablet.
Experimental: Cohort 2: E0302 Sustained Release (SR3) 1500 mcg
Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.
Drug: E0302 SR3
E0302 SR3, oral tablet.
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.
Drug: E0302 SR2
E0302 SR2, oral tablet.
Drug: E0302 IR
E0302 IR, oral tablet.
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.
Drug: E0302 SR2
E0302 SR2, oral tablet.
Drug: E0302 IR
E0302 IR, oral tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose
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
Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
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
Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
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
Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days
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
Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10
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
Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
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
Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

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 (Actual)

April 13, 2019

Primary Completion (Actual)

June 26, 2019

Study Completion (Actual)

June 26, 2019

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E0302-J064-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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