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

• ClinicalTrials.gov Identifier: NCT03885882
• Recruitment Status: Completed
• First Posted: March 22, 2019
• Last Update Posted: December 24, 2019
• Sponsor: Eisai Co., Ltd.
• Information provided by (Responsible Party): Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease	Intervention/treatment	Phase
Healthy Subjects	Drug: E0302 SR1; Drug: E0302 SR3; Drug: E0302 SR2; Drug: E0302 IR	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 13, 2019
• Actual Primary Completion Date: June 26, 2019
• Actual Study Completion Date: June 26, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
5. 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 ]
6. 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 ]
7. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

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

Contacts and Locations

Locations

New Zealand

Auckland Clinical Studies

Auckland, New Zealand

Sponsors and Collaborators

Eisai Co., Ltd.

More Information

• Responsible Party: Eisai Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03885882
• Other Study ID Numbers: E0302-J064-003
• First Posted: March 22, 2019
• Last Update Posted: December 24, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):

E0302; Healthy Subjects; E0302 SR Tablet; E0302 IR Tablet

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders