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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT02207790

Run by

Eisai Inc.

People needed

32

Starts

2014-07-01

Expected to finish

2014-10-01

Last updated by the study team

2015-11-03

Who can join

Age: 30 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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
• 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

Where it is running

• Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

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