Trial record 3 of 8 for:    E2609

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01975636
First received: October 29, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Metabolism and Elimination
Drug: E2609
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Pharmacokinetics: Elimination of E2609: urine/feces concentration [ Time Frame: Predose and every 24 hours postdose up to 28 days ] [ Designated as safety issue: No ]
    Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.

  • Pharmacokinetics: Plasma concentration of E2609/metabolite [ Time Frame: Predose andup to 648 hours postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Predose andup to 648 hours postdose ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: June 2013
Study Completion Date: March 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975636

Locations
United States, Wisconsin
Covance Laboratories
Madison, Wisconsin, United States, 53704
Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01975636     History of Changes
Other Study ID Numbers: E2609-A001-005
Study First Received: October 29, 2013
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Metabolism and Elimination

ClinicalTrials.gov processed this record on August 20, 2014