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Healthy SubjectsPhase 1NCT02207790

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects

A Phase 1 study testing E2609 in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK characteristics, the proposed study includes a cohort of white subjects treated for comparison with the cohort of Japanese subjects treated… Read more about this study

Who is it for?
Ages 30 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
E2609
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
Jul 2014to Oct 2014
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 30 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject must meet all of the following criteria in order to be included in the study.
  • Japanese Subjects Only:
  • Birth in Japan to Japanese parents and grandparents of Japanese descent
  • Have been living outside Japan for less than 5 years
  • Lifestyle, including diet, has not changed significantly since leaving Japan
  • White Subjects Only:
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  • A person having origins in any of the original peoples of Europe, the Middle East, or North Africa based on documented subject self-report
  • All Subjects:
  • Healthy male, 30 to 60 years inclusive, at the time of informed consent
  • BMI of 18 to 32 kg/m2 inclusive at Screening
  • Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception (i.e. condom plus spermicide, condom plus diaphragm with spermicide, intrauterine device starting for at least one menstrual cycle before starting study drug[s]) and throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from this study:
  • Any history of seizures or epilepsy
  • Any medical condition which, in the opinion of the investigator has high risk of seizures
  • Any history of cerebrovascular disease
  • A history of prolonged QTc interval
  • Any other clinically significant ECG abnormalities
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  • History of risk factors for torsade de pointes or the use of medications that prolonged the QT/QTc interval
  • Heart rate less than 50 or greater than 100 beats/min
  • History of ischemic heart disease
  • Persistent systolic blood pressure (BP) greater than 140 mmHg or less than 90 mmHg and diastolic BP greater than 90 mmHg or less than 60 mmHg
  • Left bundle branch block
  • Evidence of clinically significant disease
  • Any laboratory abnormalities considered clinically significant
  • Clinically significant illness which requires medical treatment
  • Any history of abdominal surgery that may affect study drugs
  • Hypersensitivity to the study drug
  • Known to be HIV positive
  • Active viral hepatitis
  • History of drug or alcohol dependency or abuse within approximately the last 2 years
  • Scheduled for surgery during the study
  • Engagement in strenuous exercise within 2 weeks before dosing (eg, marathon runners, weight lifters)
  • Currently enrolled in another clinical trial or used any investigational drug or device within 30 days before informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Glendale, California

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects

This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK characteristics, the proposed study includes a cohort of white subjects treated for comparison with the cohort of Japanese subjects treated at the same dose. This comparison serves as a key PK bridge in assessing ethnic factors that may contribute to differences in plasma concentrations. Pharmacokinetic assessments in the proposed study will include confirmation of dose proportionality in Japanese subjects. This study will also evaluate safety and tolerability in Japanese subjects.

Being tested
E2609, Placebo
Keywords
Clinical Trial, Phase I, Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E2609Drug

  • PlaceboDrug

    E2609 low-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy Japanese subjects, E2609 high-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy White subjects

Study groups in NCT02207790
Study groupRoleWhat they receive
E2609 low-dose and placebo in healthy Japanese subjectsExperimentalCohort 1 will consist of Japanese subjects randomized to a low-dose of E2609 as an orally administered tablet along with subjects receiving matching placebo tablets (matched in number and appearance).
Receives: Drug: E2609; Drug: Placebo
E2609 mid-dose and placebo in healthy Japanese subjectsExperimentalCohort 2 will consist of Japanese subjects randomized to a mid-dose of E2609 as an orally administered tablet along with subjects receiving matching placebo tablets (matched in number and appearance).
Receives: Drug: E2609; Drug: Placebo
E2609 high-dose and placebo in healthy Japanese subjectsExperimentalCohort 3 will consist of Japanese subjects randomized to a high-dose of E2609 as an orally administered tablet along with subjects receiving matching placebo tablets (matched in number and appearance).
Receives: Drug: E2609; Drug: Placebo
E2609 mid-dose and placebo in healthy White subjectsExperimentalCohort 4 will consist of White subjects randomized to a mid-dose of E2609 as an orally administered tablet along with subjects receiving matching placebo tablets (matched in number and appearance).
Receives: Drug: E2609; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics of E2609: Cmax

    Measured: Up to Day 10 (216 hours postdose)

  2. Pharmacokinetics of E2609: tmax

    Measured: Up to Day 10 (216 hours postdose)

  3. Pharmacokinetics of E2609: AUC(0-24h)+D90

    Measured: Up to Day 10 (216 hours postdose)

  4. Pharmacokinetics of E2609: AUC(0-72h)

    Measured: Up to Day 10 (216 hours postdose)

  5. Pharmacokinetics of E2609: AUC(0-t)

    Measured: Up to Day 10 (216 hours postdose)

  6. Pharmacokinetics of E2609: AUC(0-inf)

    Measured: Up to Day 10 (216 hours postdose)

  7. Pharmacokinetics of E2609: AUC Metabolite Ratio

    Measured: Up to Day 10 (216 hours postdose)

  8. Pharmacokinetics of E2609: t1/2

    Measured: Up to Day 10 (216 hours postdose)

  9. Pharmacokinetics of E2609: CL/F

    Measured: Up to Day 10 (216 hours postdose)

  10. Pharmacokinetics of E2609: V/F

    Measured: Up to Day 10 (216 hours postdose)

  11. To evaluate the safety and tolerability of E2609

    Safety will be assessed by monitoring and recording all adverse events (AEs), serious adverse events (SAEs), regular monitoring of hematology, blood chemistry, urine values, regular measurement of vital signs, ECGs and performance of physical examinations

    Measured: Baseline and up to 30 days from last dosing of subject

Secondary outcomes (6)

  1. Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): Amax

    Measured: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10

  2. Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): T(Amax)

    Measured: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10

  3. Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): AUAC(-24h-0h)

    Measured: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10

  4. Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): AUAC(0-144h)

    Measured: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10

  5. Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): Change in AUAC

    Measured: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10

  6. Change from baseline in QTcF obtained from ECGs extracted from Holter recordings

    Holter ECG measurements will start on Day -1, at a time equivalent to 24 hours predose, and will continue for 24 hours postdose of Day 1, with interruptions allowed to adjust equipment. ECGs will be extracted from Holter monitors.

    Measured: Baseline, Day 1, and Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionAug 2014
  4. Study completionOct 2014

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02207790
Sponsor's protocol ID
E2609-A001-006
Status last verified
Nov 2015
First submitted
31 Jul 2014
Last updated
3 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E2609 in people with Healthy Subjects, run by Eisai Inc. at 1 site in United States.

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 11 inclusion and 22 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 3 Nov 2015. 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 United States. 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?

Pharmacokinetics of E2609: Cmax (time frame: Up to Day 10 (216 hours postdose)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02207790.

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 3 Nov 2015.

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