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OpenTrials
Completed

NCT Number: 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

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Auckland Clinical Studies

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

E0302 SR1

Drug

E0302 SR1, oral tablet.

E0302 SR3

Drug

E0302 SR3, oral tablet.

E0302 SR2

Drug

E0302 SR2, oral tablet.

E0302 IR

Drug

E0302 IR, oral tablet.

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR

    Time frame: Cohort 1 and 2 Day 1: 0-72 hours post dose; Cohort 3 Day 1 or 7: 0-72 hours post dose

  2. AUC (0-t): Area Under the Concentration-Time Curve From Zero Time to Time of Last Quantifiable Concentration

    Time frame: Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose

  3. AUC (0 - infinity): Area Under the Concentration-Time Curve From Zero Time Extrapolated to Infinite Time

    Time frame: Cohort 1 and 2 Day 1: 0-72 hours post dose, Cohort 3 Day 1 or 7: 0-72 hours post dose

  4. Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)

    Time frame: Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days

  5. Number of Participants With Abnormal Clinical Laboratory Values

    Time frame: Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10

  6. Number of Participants With Abnormal Vital Sign Values

    Time frame: Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8

  7. Number of Participants With Abnormal 12-lead Electrocardiogram Values

    Time frame: Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2019
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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