An Open-label, Single-dose Study to Determine the Metabolism and Excretion of [14C]E2006 in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Metabolism and Excretion

In brief

The purpose of this study is to determine the metabolism and excretion of \[14C\]E2006 in healthy male subjects.

Key facts

Study ID

NCT02046213

Run by

Eisai Inc.

People needed

16

Starts

2014-02-01

Expected to finish

2014-05-01

Last updated by the study team

2015-11-03

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male 18 to 55 years, inclusive, at the time of informed consent
• Body mass index (BMI) of 18 to 32 kg/m2 at Screening
• 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 throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
• Provide written informed consent
• Willing and able to comply with all aspects of the protocol

You may not qualify if…

• Participated in a 14C research study within the 6 months prior to Day -2. The total radiation exposure to radiolabelled compounds from this study and any previous studies must be within the recommended levels considered safe (per US 21 CFR 361.1)
• Exposure to clinically significant radiation (greater than 100 milliseiverts) within 12 months prior to Day -2
• Any history of cerebrovascular disease (stroke or transient ischemic attack)
• A prolonged QT/QTc interval (QTc greater than 450 msec) as demonstrated upon confirmatory ECG if first ECG indicates prolonged QT/QTc interval
• History of prolonged QT/QTc interval
• History of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or the use of concomitant medications that prolonged the QT/QTc interval
• Heart rate less than 40 or greater than 100 beats/min at Screening or Baseline
• History of ischemic heart disease (e.g., acute coronary syndromes, stable angina), syncope or cardiac arrhythmias
• Systolic blood pressure greater than 140 mmHg or less than 90 mmHg or diastolic blood pressure greater than 90 mmHg or less than 60 mmHg at Screening or Baseline
• Hemoglobin less than 12.5 g/dL or hemotocrit less than or equal to 38% at Baseline check-in
• Evidence of clinically significant disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments
• Any laboratory abnormalities considered clinically significant by the investigator
• Clinically significant illness which required medical treatment within 8 weeks of dosing or a clinically significant infection within 4 weeks of dosing
• Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
• Hypersensitivity to the study drug or any of its excipients
• Known to be human immunodeficiency virus (HIV) positive or positive on viral screen for HIV or viral hepatitis B or hepatitis C
• History of drug or alcohol dependency or abuse within approximately the last 2 years or who have a positive urine drug test or breath alcohol test at Screening or Baseline
• Do not meet the restrictions on concomitant medications, food and beverages (see below)
• Use of illegal (or legalized) recreational drugs in the past year
• Engagement in strenuous exercise within 2 weeks prior to dosing (e.g., marathon runners, weight lifters)
• Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent
• Restrictions on prior and concomitant medications, food and beverages
• Prescription drugs are prohibited within 4 weeks of dosing and over-the-counter drugs within 2 weeks prior to dosing or throughout the Treatment Period
• Smoking or use of tobacco or nicotine-containing products is prohibited within 4 weeks prior to dosing and throughout the Treatment Period
• Intake of caffeinated beverages or food is prohibited within 72 hours prior to dosing and until 72 hours postdose

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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