Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02207790
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief 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 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 or disease Intervention/treatment Phase
Healthy Subjects Drug: E2609 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
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
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

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
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

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
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

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
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




Primary Outcome Measures :
  1. Pharmacokinetics of E2609: Cmax [ Time Frame: Up to Day 10 (216 hours postdose) ]
  2. Pharmacokinetics of E2609: tmax [ Time Frame: Up to Day 10 (216 hours postdose) ]
  3. Pharmacokinetics of E2609: AUC(0-24h)+D90 [ Time Frame: Up to Day 10 (216 hours postdose) ]
  4. Pharmacokinetics of E2609: AUC(0-72h) [ Time Frame: Up to Day 10 (216 hours postdose) ]
  5. Pharmacokinetics of E2609: AUC(0-t) [ Time Frame: Up to Day 10 (216 hours postdose) ]
  6. Pharmacokinetics of E2609: AUC(0-inf) [ Time Frame: Up to Day 10 (216 hours postdose) ]
  7. Pharmacokinetics of E2609: AUC Metabolite Ratio [ Time Frame: Up to Day 10 (216 hours postdose) ]
  8. Pharmacokinetics of E2609: t1/2 [ Time Frame: Up to Day 10 (216 hours postdose) ]
  9. Pharmacokinetics of E2609: CL/F [ Time Frame: Up to Day 10 (216 hours postdose) ]
  10. Pharmacokinetics of E2609: V/F [ Time Frame: Up to Day 10 (216 hours postdose) ]
  11. To evaluate the safety and tolerability of E2609 [ Time Frame: Baseline and up to 30 days from last dosing of subject ]
    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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Change from baseline in QTcF obtained from ECGs extracted from Holter recordings [ Time Frame: Baseline, Day 1, and Day 2 ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes 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

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): NCT02207790


Locations
Layout table for location information
United States, California
Glendale, California, United States
Sponsors and Collaborators
Eisai Inc.

Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02207790     History of Changes
Other Study ID Numbers: E2609-A001-006
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015

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