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

Phase 1

Completed

• Conditions: Metabolism and Elimination
• Interventions: Drug: E2609

• Registration Number: NCT01975636
• Lead Sponsor: Eisai Inc.

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

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Primary Completion: 2013-11
• Study First Posted: 2013-11-05
• Study Completion: 2014-03
• Status Verified: 2015-11
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 113

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration	Predose andup to 648 hours postdose	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.

Trial Locations

Locations (2)

Covance Clinical Research Unit Inc.; 🇺🇸 Madison, Wisconsin, United States

Covance Laboratories; 🇺🇸 Madison, Wisconsin, United States