An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Metabolism and Elimination

In brief

This is an open-label, single dose study in healthy male subjects.

Key facts

Study ID

NCT01975636

Run by

Eisai Inc.

People needed

113

Starts

2013-06-01

Expected to finish

2014-03-01

Last updated by the study team

2016-01-08

Who can join

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

You may qualify if…

• Subjects must meet criteria to be included in this study, including but not limited to the following:
• Healthy male 18 - 55 years, inclusive, at the time of informed consent
• Body mass index (BMI) of 18 to 32 kg/m2 at Screening
• Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 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…

• Subjects who meet any of the following criteria will be excluded from this study:
• Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.
• Exposure to clinically significant radiation within 12 months prior to Day -2.
• Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
• Clinically significant illness which required medical treatment within 8 weeks 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 drugs or any of their excipients
• Known to be human immunodeficiency virus (HIV) positive
• Restrictions will apply on prior and concomitant medications, food and beverages

Where it is running

• Covance Clinical Research Unit Inc. — Madison, Wisconsin, United States
• Covance Laboratories — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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