Clinical trial NCT03885882: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: E0302
Healthy Subjects
E0302 SR Tablet
E0302 IR Tablet
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort 1 and Cohort 2 will receive treatment as parallel assignment. Cohort 3 will receive treatment in cross-over manner.
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR
timeFrame: Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose
measure: AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration
timeFrame: Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
measure: AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time
timeFrame: Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose
measure: Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
timeFrame: Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days
measure: Number of Participants With Abnormal Clinical Laboratory Values
timeFrame: Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10
measure: Number of Participants With Abnormal Vital Sign Values
timeFrame: Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
measure: Number of Participants With Abnormal 12-lead Electrocardiogram Values
timeFrame: Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
Study officials:
References: