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

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

Study Overview

• Status: Completed
• Conditions: Metabolism and Elimination
• Intervention / Treatment: Drug: E2609

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

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit Inc.
    • Madison, Wisconsin, United States, 53704
      • Covance Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E2609; Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance	Drug: E2609; Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Elimination of E2609: urine/feces concentration	Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.	Predose and every 24 hours postdose up to 28 days
Pharmacokinetics: Plasma concentration of E2609/metabolite	Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.	Predose andup to 648 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration	Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography [HPLC]) methods. A scintillation counter and/or AMS will be used to detect radioactivity. If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses.	Predose andup to 648 hours postdose

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: October 29, 2013
• First Posted (Estimate): November 5, 2013

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 6, 2016
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Metabolism and Elimination
• Other Study ID Numbers: E2609-A001-005