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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: E0302 IR; Drug: E0302 SR1; Drug: E0302 SR3; Drug: E0302 SR2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03885882

E0302-J064-003

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Cohort 1: E0302 Sustained Release (SR1) 1500 mcg

Experimental group

Description:

Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.

Treatment:

Drug: E0302 SR1

Cohort 2: E0302 Sustained Release (SR3) 1500 mcg

Experimental group

Description:

Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.

Treatment:

Drug: E0302 SR3

Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg

Experimental group

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.

Treatment:

Drug: E0302 IR

Drug: E0302 SR2

Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg

Experimental group

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.

Treatment:

Drug: E0302 IR

Drug: E0302 SR2