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

NCT03885882 | Completed Phase 1

• 1 other identifier: E0302-J064-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (4)

Cohort 1: E0302 Sustained Release (SR1) 1500 mcg

EXPERIMENTAL

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

Drug: E0302 SR1

Cohort 2: E0302 Sustained Release (SR3) 1500 mcg

EXPERIMENTAL

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

Drug: E0302 SR3

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

EXPERIMENTAL

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; Drug: E0302 IR

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

EXPERIMENTAL

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; Drug: E0302 IR

Interventions

E0302 SR1 DRUG

E0302 SR1, oral tablet.

Cohort 1: E0302 Sustained Release (SR1) 1500 mcg

E0302 SR3 DRUG

E0302 SR3, oral tablet.

Cohort 2: E0302 Sustained Release (SR3) 1500 mcg

E0302 SR2 DRUG

E0302 SR2, oral tablet.

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

E0302 IR DRUG

E0302 IR, oral tablet.

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

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria to be included in this study:
• \. Body mass index (BMI) of 18 to 30 kilogram per meter square \[kg/m2\], inclusive at Screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Auckland Clinical Studies

Auckland, New Zealand

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort 1 and Cohort 2 will receive treatment as parallel assignment. Cohort 3 will receive treatment in cross-over manner.

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 22, 2019
• Study Start: April 13, 2019
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

NZ (1)