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

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

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: E0302 SR1
* Drug: E0302 SR3
* Drug: E0302 SR2
* Drug: E0302 IR


Participation Criteria
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Eligibility Criteria
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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: 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 Subjects who contravene the restrictions on concomitant medications, food and beverages Currently enrolled in another clinical study or used any investigational drug or device within 3 months preceding informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: E0302 Sustained Release (SR1) 1500 mcg<br>Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1. | Drug: E0302 SR1<br>* E0302 SR1, oral tablet.<br>|
| Experimental: Cohort 2: E0302 Sustained Release (SR3) 1500 mcg<br>Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1. | Drug: E0302 SR3<br>* E0302 SR3, oral tablet.<br>|
| Experimental: Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg<br>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<br>* E0302 SR2, oral tablet.<br>Drug: E0302 IR<br>* E0302 IR, oral tablet.<br>|
| Experimental: Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg<br>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<br>* E0302 SR2, oral tablet.<br>Drug: E0302 IR<br>* E0302 IR, oral tablet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Clinical Laboratory Values |  | Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10 | 
| 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 12-lead Electrocardiogram Values |  | Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E0302, Healthy Subjects, E0302 SR Tablet, E0302 IR Tablet