A Study of [¹⁴C]-LY3202626 in Healthy Male Participants
Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects
The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it takes the body to get rid of it.
Information about any side effects that may occur will also be collected.
Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.
This study is for research purposes only and is not intended to treat any medical condition.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
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Wisconsin
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Madison, Wisconsin, 미국, 53704
- Covance Clinical Research Unit Inc.
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening
Exclusion Criteria:
- Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
- Have a history of constipation or have had acute constipation within 3 weeks prior to admission
- Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
- Exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: [¹⁴C]-LY3202626
Single oral dose of LY3202626 containing 100 micro curies of radioactivity
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Administered as solution by mouth
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
기간: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
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Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
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Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
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Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
기간: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
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Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered
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Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)
기간: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
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Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax).
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Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
|
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞])
기간: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
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Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]).
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Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
|
Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])
기간: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]).
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
|
Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma
기간: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
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Total number of metabolites were identified in at least 10% of the total radioactivity in plasma.
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Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
|
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Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity
기간: From Dosing Until Release Criteria Is Met
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The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity
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From Dosing Until Release Criteria Is Met
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 15566
- I7X-EW-LLCC (기타 식별자: Eli Lilly and Company)
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