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

NCT01975636 | Completed Phase 1

• 1 other identifier: E2609-A001-005
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Metabolism and Elimination

Keywords

Metabolism and Elimination

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration

  Predose andup to 648 hours postdose

Study Arms (1)

E2609

EXPERIMENTAL

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

Drug: E2609

Interventions

E2609 DRUG

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

E2609

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Covance Laboratories

Madison, Wisconsin, 53704, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: January 8, 2016

Record last verified: 2015-11

Locations

US (2)