An Open-label, Single-dose Study to Determine the Metabolism and Excretion of [14C]E2006 in Healthy Male Subjects

NCT02046213 | Completed Phase 1

• 1 other identifier: E2006-A001-007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the metabolism and excretion of \[14C\]E2006 in healthy male subjects.

Conditions

Metabolism and Excretion

Keywords

Metabolism and Excretion

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Excretion of E2006: urine/feces concentration

  Total radioactivity derived from \[14C\]E2006-related material and E2006 will be analyzed in urine and feces. \[14C\]E2006 radiolabeled material will be quantified in urine and feces for total radioactivity using a scintillation counting method and/or an accelerator mass spectrometry.

  Up to 35 days

• Pharmacokinetics: Plasma concentration of E2006/metabolite

  Total radioactivity derived from \[14C\]E2006-related material, E2006, and metabolites will be analyzed in whole blood, plasma, and red blood cells. \[14C\]E2006 radiolabeled material will be quantified in whole blood, plasma, red blood cells for total radioactivity using a scintillation counting method and/or accelerator mass spectrometry.

  Up to 816 hours postdose

Secondary Outcomes (1)

• Pharmacokinetics: Metabolic profile of E2006: plasma/urine/feces concentration

  Urine/Feces: Up to 35 days; Plasma: Up to 816 hours postdose

Study Arms (1)

E2006

EXPERIMENTAL

Single oral 10mg dose of 100 uCi \[14C\]E2006

Drug: E2006

Interventions

E2006 DRUG

Single oral 10mg dose of 100 uCi \[14C\]E2006

E2006

Eligibility Criteria

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

You may qualify if:

• Healthy male 18 to 55 years, inclusive, at the time of informed consent
• Body mass index (BMI) of 18 to 32 kg/m2 at Screening
• Must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 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:

• Participated in a 14C research study within the 6 months prior to Day -2. The total radiation exposure to radiolabelled compounds from this study and any previous studies must be within the recommended levels considered safe (per US 21 CFR 361.1)
• Exposure to clinically significant radiation (greater than 100 milliseiverts) within 12 months prior to Day -2
• Any history of cerebrovascular disease (stroke or transient ischemic attack)
• A prolonged QT/QTc interval (QTc greater than 450 msec) as demonstrated upon confirmatory ECG if first ECG indicates prolonged QT/QTc interval
• History of prolonged QT/QTc interval
• History of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or the use of concomitant medications that prolonged the QT/QTc interval
• Heart rate less than 40 or greater than 100 beats/min at Screening or Baseline
• History of ischemic heart disease (e.g., acute coronary syndromes, stable angina), syncope or cardiac arrhythmias
• Systolic blood pressure greater than 140 mmHg or less than 90 mmHg or diastolic blood pressure greater than 90 mmHg or less than 60 mmHg at Screening or Baseline
• Hemoglobin less than 12.5 g/dL or hemotocrit less than or equal to 38% at Baseline check-in
• Evidence of clinically significant disease (e.g., psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments
• Any laboratory abnormalities considered clinically significant by the investigator
• Clinically significant illness which required medical treatment within 8 weeks of dosing 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 drug or any of its excipients

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, United States

Location

Study Design

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

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)