Healthy SubjectsPhase 1NCT03885882
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
A Phase 1 study testing E0302 SR1, E0302 SR3 and E0302 SR2 in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in New Zealand.
Trial summary
To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- E0302 SR1, E0302 SR3 and E0302 SR2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNew Zealand
- Study dates
- 13 Apr 2019to 26 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- E0302 SR1, E0302 SR3, E0302 SR2, E0302 IR
- Keywords
- E0302, Healthy Subjects, E0302 SR Tablet, E0302 IR Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E0302 SR1Drug
E0302 SR1, oral tablet.
E0302 SR3Drug
E0302 SR3, oral tablet.
E0302 SR2Drug
E0302 SR2, oral tablet.
E0302 IRDrug
E0302 IR, oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: E0302 SR2; Drug: E0302 IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for E0302 SR1, SR2, SR3 and IR
Measured: 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
Measured: 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
Measured: 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)
Measured: Cohort 1 and Cohort 2: Up to 12 days, Cohort 3: Up to 18 days
Number of Participants With Abnormal Clinical Laboratory Values
Measured: Cohort 1 and Cohort 2: Up to Day 4, Cohort 3: Up to Day 10
Number of Participants With Abnormal Vital Sign Values
Measured: Cohort 1 and Cohort 2: Up to Day 2, Cohort 3: Up to Day 8
Number of Participants With Abnormal 12-lead Electrocardiogram Values
Measured: Cohort 1 and Cohort 2: Up to Day 12, Cohort 3: Up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start13 Apr 2019
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885882
- Sponsor's protocol ID
- E0302-J064-003
- Status last verified
- Jan 2019
- First submitted
- 6 Mar 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03885882
- Acronym / sponsor ID
- E0302-J064-003
- Conditions
- Healthy Subjects
- Keywords
- E0302, Healthy Subjects, E0302 SR Tablet, E0302 IR Tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cohort 1 and Cohort 2 will receive treatment as parallel assignment. Cohort 3 will receive treatment in cross-over manner.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: E0302 Sustained Release (SR1) 1500 mcg | Experimental | Drug: E0302 SR1Participants will receive a single dose of E0302 SR1 1500 microgram (mcg), tablet, orally on Day 1. |
| Cohort 2: E0302 Sustained Release (SR3) 1500 mcg | Experimental | Drug: E0302 SR3Participants will receive a single dose of E0302 SR3 1500 mcg, tablet on Day 1. |
| Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg | Experimental | Drug: E0302 SR2, Drug: E0302 IRParticipants 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. |
| Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg | Experimental | Drug: E0302 SR2, Drug: E0302 IRParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Body mass index (BMI) of 18 to 30 kilogram per meter square [kg/m2], inclusive at Screening
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E0302 SR1E0302 SR1, oral tablet. | Drug | Cohort 1: E0302 Sustained Release (SR1) 1500 mcg |
| E0302 SR3E0302 SR3, oral tablet. | Drug | Cohort 2: E0302 Sustained Release (SR3) 1500 mcg |
| E0302 SR2E0302 SR2, oral tablet. | Drug | Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg, Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg |
| E0302 IRE0302 IR, oral tablet. | Drug | Cohort 3: E0302 IR 500 mcg + E0302 SR2 500 mcg, Cohort 3: E0302 SR2 1500 mcg + E0302 IR 500 mcg |
Primary outcome
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E0302 SR1, E0302 SR3 and E0302 SR2 in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.