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

2015년 11월 2일 업데이트: Eisai Inc.
The purpose of this study is to determine the metabolism and excretion of [14C]E2006 in healthy male subjects.

연구 개요

상태

완전한

개입 / 치료

상세 설명

This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's eligibility will be determined and assessments will be conducted.

연구 유형

중재적

등록 (실제)

16

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Wisconsin
      • Madison, Wisconsin, 미국
        • Covance Clinical Research Unit

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

남성

설명

Inclusion Criteria

  1. Healthy male 18 to 55 years, inclusive, at the time of informed consent
  2. Body mass index (BMI) of 18 to 32 kg/m2 at Screening
  3. 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.
  4. Provide written informed consent
  5. Willing and able to comply with all aspects of the protocol

Exclusion Criteria

  1. 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)
  2. Exposure to clinically significant radiation (greater than 100 milliseiverts) within 12 months prior to Day -2
  3. Any history of cerebrovascular disease (stroke or transient ischemic attack)
  4. A prolonged QT/QTc interval (QTc greater than 450 msec) as demonstrated upon confirmatory ECG if first ECG indicates prolonged QT/QTc interval
  5. History of prolonged QT/QTc interval
  6. 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
  7. Heart rate less than 40 or greater than 100 beats/min at Screening or Baseline
  8. History of ischemic heart disease (e.g., acute coronary syndromes, stable angina), syncope or cardiac arrhythmias
  9. 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
  10. Hemoglobin less than 12.5 g/dL or hemotocrit less than or equal to 38% at Baseline check-in
  11. 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
  12. Any laboratory abnormalities considered clinically significant by the investigator
  13. Clinically significant illness which required medical treatment within 8 weeks of dosing or a clinically significant infection within 4 weeks of dosing
  14. Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
  15. Hypersensitivity to the study drug or any of its excipients
  16. Known to be human immunodeficiency virus (HIV) positive or positive on viral screen for HIV or viral hepatitis B or hepatitis C
  17. History of drug or alcohol dependency or abuse within approximately the last 2 years or who have a positive urine drug test or breath alcohol test at Screening or Baseline
  18. Do not meet the restrictions on concomitant medications, food and beverages (see below)
  19. Use of illegal (or legalized) recreational drugs in the past year
  20. Engagement in strenuous exercise within 2 weeks prior to dosing (e.g., marathon runners, weight lifters)
  21. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent

    Restrictions on prior and concomitant medications, food and beverages

  22. Prescription drugs are prohibited within 4 weeks of dosing and over-the-counter drugs within 2 weeks prior to dosing or throughout the Treatment Period
  23. Smoking or use of tobacco or nicotine-containing products is prohibited within 4 weeks prior to dosing and throughout the Treatment Period
  24. Intake of caffeinated beverages or food is prohibited within 72 hours prior to dosing and until 72 hours postdose
  25. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect CYP3A4 enzyme or transporters (e.g., alcohol, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or orange juice, vegetables from the mustard green family [e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard] and charbroiled meats) is prohibited within 2 weeks prior to dosing and throughout the Treatment Period
  26. Intake of herbal preparations containing St. John's Wort is prohibited within 4 weeks prior to dosing and throughout the Treatment Period
  27. Any subject that has a known history of malaria or has traveled to a country with known malarial risk (ie, designated as a 'high' or 'moderate' risk country according to the list available athttp://www.cdc.gov/malaria) within the last year

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: E2006
Single oral 10mg dose of 100 uCi [14C]E2006
Single oral 10mg dose of 100 uCi [14C]E2006

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pharmacokinetics: Excretion of E2006: urine/feces concentration
기간: Up to 35 days
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
기간: Up to 816 hours postdose
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

2차 결과 측정

결과 측정
측정값 설명
기간
Pharmacokinetics: Metabolic profile of E2006: plasma/urine/feces concentration
기간: Urine/Feces: Up to 35 days; Plasma: Up to 816 hours postdose
Metabolite profiling in plasma, urine, and feces will be performed by radio-high performance liquid chromatography (radio-HPLC) methods. Metabolites will be identified on the radiochromatograms, and the amount of the each metabolite will be quantified based on the peak areas on the chromatograms. For metabolites detected on the radiochromatograms, LC/MS/MS analysis will be performed to estimate and identify their chemical structures.
Urine/Feces: Up to 35 days; Plasma: Up to 816 hours postdose

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 2월 1일

기본 완료 (실제)

2014년 4월 1일

연구 완료 (실제)

2014년 5월 1일

연구 등록 날짜

최초 제출

2014년 1월 23일

QC 기준을 충족하는 최초 제출

2014년 1월 24일

처음 게시됨 (추정)

2014년 1월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 11월 2일

마지막으로 확인됨

2015년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • E2006-A001-007

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