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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885882
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: E0302 SR1 Drug: E0302 SR3 Drug: E0302 SR2 Drug: E0302 IR Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2019
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Cohort 1: E0302 Sustained Release (SR1) 1500 mcg
Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1.
Drug: E0302 SR1
E0302 SR1, oral tablet.

Experimental: Cohort 2: E0302 Sustained Release (SR3) 1500 mcg
Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1.
Drug: E0302 SR3
E0302 SR3, oral tablet.

Experimental: Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg
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
E0302 SR2, oral tablet.

Drug: E0302 IR
E0302 IR, oral tablet.

Experimental: Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg
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
E0302 SR2, oral tablet.

Drug: E0302 IR
E0302 IR, oral tablet.




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885882


Locations
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New Zealand
Auckland Clinical Studies
Auckland, New Zealand
Sponsors and Collaborators
Eisai Co., Ltd.
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03885882    
Other Study ID Numbers: E0302-J064-003
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
E0302
Healthy Subjects
E0302 SR Tablet
E0302 IR Tablet
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders