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

NCT ID: NCT01975636

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-03-31

Brief Summary

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

Detailed Description

A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.

On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:

• greater than 90% of the administered radioactivity has been recovered, and
• less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces

Conditions

Metabolism and Elimination

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

E2609

Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance

Group Type: EXPERIMENTAL

E2609

Intervention Type: DRUG

Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance

Interventions

E2609

Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects must meet criteria to be included in this study, including but not limited to the following:

1. Healthy male 18 - 55 years, inclusive, at the time of informed consent

2. Body mass index (BMI) of 18 to 32 kg/m2 at Screening

3. 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.

4. Provide written informed consent

5. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

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

1. 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.

2. Exposure to clinically significant radiation within 12 months prior to Day -2.

3. Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment

4. Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing

5. Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs

6. Hypersensitivity to the study drugs or any of their excipients

7. Known to be human immunodeficiency virus (HIV) positive

Restrictions will apply on prior and concomitant medications, food and beverages

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit Inc.

Madison, Wisconsin, United States

Covance Laboratories

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

E2609-A001-005

Identifier Type: -

Identifier Source: org_study_id