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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885882
• Other study ID #: E0302-J064-003
• Status: Completed
• Phase: Phase 1
• Start date: April 13, 2019
• Est. completion date: June 26, 2019

Study information

• Verified date: January 2019
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects
• Malnutrition

Intervention

Drug:
• E0302 SR1
E0302 SR1, oral tablet.
• E0302 SR3
E0302 SR3, oral tablet.
• E0302 SR2
E0302 SR2, oral tablet.
• E0302 IR
E0302 IR, oral tablet.

Locations

Country	Name	City	State
New Zealand	Auckland Clinical Studies	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

New Zealand, 

Outcome

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