ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 13 for:    E2609
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01975636
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

October 29, 2013
November 5, 2013
January 8, 2016
June 2013
November 2013   (Final data collection date for primary outcome measure)
  • Pharmacokinetics: Elimination of E2609: urine/feces concentration [ Time Frame: 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 [ Time Frame: Predose andup to 648 hours postdose ]
    Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.
Same as current
Complete list of historical versions of study NCT01975636 on ClinicalTrials.gov Archive Site
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
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.

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
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metabolism and Elimination
Drug: E2609
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
Experimental: E2609
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
Intervention: Drug: E2609
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
8
March 2014
November 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01975636
E2609-A001-005
No
Not Provided
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Not Provided
Eisai Inc.
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP