Trial record 1 of 30 for:    E2609
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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT02207790
First received: July 31, 2014
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: E2609
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Pharmacokinetics of E2609: Cmax [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: tmax [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: AUC(0-24h)+D90 [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: AUC(0-72h) [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: AUC(0-t) [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: AUC(0-inf) [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: AUC Metabolite Ratio [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: t1/2 [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: CL/F [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • Pharmacokinetics of E2609: V/F [ Time Frame: Up to Day 10 (216 hours postdose) ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of E2609 [ Time Frame: Baseline and up to 30 days from last dosing of subject ] [ Designated as safety issue: Yes ]
    Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs, ECGs, and the performance of physical e


Secondary Outcome Measures:
  • Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): Amax [ Time Frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10 ] [ Designated as safety issue: No ]
  • Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): T(Amax) [ Time Frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10 ] [ Designated as safety issue: No ]
  • Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): AUAC(-24h-0h) [ Time Frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10 ] [ Designated as safety issue: No ]
  • Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): AUAC(0-144h) [ Time Frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10 ] [ Designated as safety issue: No ]
  • Pharmacodynamic effect of E2609: percent change from baseline of plasma (AB[1-x]): Change in AUAC [ Time Frame: Baseline, Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10 ] [ Designated as safety issue: No ]
  • Change from baseline in QTcF obtained from ECGs extracted from Holter recordings [ Time Frame: Baseline, Day 1, and Day 2 ] [ Designated as safety issue: No ]
    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 at the following times :


Estimated Enrollment: 32
Study Start Date: August 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E2609 low-dose and placebo in healthy Japanese subjects
Cohort 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).
Drug: E2609 Drug: Placebo
Experimental: E2609 mid-dose and placebo in healthy Japanese subjects
Cohort 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).
Drug: E2609 Drug: Placebo
Experimental: E2609 high-dose and placebo in healthy Japanese subjects
Cohort 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).
Drug: E2609 Drug: Placebo
Experimental: E2609 mid-dose and placebo in healthy White subjects
Cohort 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).
Drug: E2609 Drug: Placebo

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The subject must meet all of the following criteria in order to be included in the study.

Japanese Subjects Only:

  1. Birth in Japan to Japanese parents and grandparents of Japanese descent
  2. Have been living outside Japan for less than 5 years
  3. Lifestyle, including diet, has not changed significantly since leaving Japan

    White Subjects Only:

  4. 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:

  5. Healthy male, 30 to 60 years inclusive, at the time of informed consent
  6. BMI of 18 to 32 kg/m2 inclusive at Screening
  7. 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.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

  1. Any history of seizures or epilepsy
  2. Any medical condition which, in the opinion of the investigator has high risk of seizures
  3. Any history of cerebrovascular disease
  4. A history of prolonged QTc interval
  5. Any other clinically significant ECG abnormalities
  6. History of risk factors for torsade de pointes or the use of medications that prolonged the QT/QTc interval
  7. Heart rate less than 50 or greater than 100 beats/min
  8. History of ischemic heart disease
  9. 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
  10. Left bundle branch block
  11. Evidence of clinically significant disease
  12. Any laboratory abnormalities considered clinically significant
  13. Clinically significant illness which requires medical treatment
  14. Any history of abdominal surgery that may affect study drugs
  15. Hypersensitivity to the study drug
  16. Known to be HIV positive
  17. Active viral hepatitis
  18. History of drug or alcohol dependency or abuse within approximately the last 2 years
  19. Scheduled for surgery during the study
  20. Engagement in strenuous exercise within 2 weeks before dosing (eg, marathon runners, weight lifters)
  21. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days before informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02207790

Contacts
Contact: Eisai Medical Services 1-888-422-4743

Locations
United States, California
Recruiting
Glendale, California, United States
Sponsors and Collaborators
Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02207790     History of Changes
Other Study ID Numbers: E2609-A001-006
Study First Received: July 31, 2014
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Clinical Trial, Phase I
Healthy Volunteers

ClinicalTrials.gov processed this record on September 18, 2014