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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: E0302 SR1; Drug: E0302 SR3; Drug: E0302 SR2; Drug: E0302 IR

• Registration Number: NCT03885882
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Study Start: 2019-04-13
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: E0302 Sustained Release (SR1) 1500 mcg	E0302 SR1	Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.
Cohort 2: E0302 Sustained Release (SR3) 1500 mcg	E0302 SR3	Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.
Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg	E0302 SR2	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.
Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg	E0302 IR	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.
Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg	E0302 SR2	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.
Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg	E0302 IR	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.

Primary Outcome Measures

Name	Time	Method
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
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
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
Number of Participants With Abnormal 12-lead Electrocardiogram Values	Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18
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
Number of Participants With Abnormal Vital Sign Values	Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
Number of Participants With Abnormal Clinical Laboratory Values	Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10

Trial Locations

Locations (1)

Auckland Clinical Studies; 🇳🇿 Auckland, New Zealand