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

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01975636

Collaborator

(none)

113

Enrollment

Locations

Arm

Duration (Months)

56.5

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolism and Elimination	Drug: E2609	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit Inc.	Madison	Wisconsin	United States	53704
2	Covance Laboratories	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Eisai Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT01975636

Other Study ID Numbers:

E2609-A001-005

First Posted:

Nov 5, 2013

Last Update Posted:

Jan 8, 2016

Last Verified:

Nov 1, 2015

Keywords provided by Eisai Inc.

Metabolism and Elimination

Study Results

No Results Posted as of Jan 8, 2016