A Study of Evacetrapib in Participants With Abnormal Cholesterol
A Phase 1b Study to Characterize the Pharmacokinetics of Evacetrapib and Potential for Accumulation After Dosing for 12, 24, and 52 Weeks
The main purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given once a day for 12, 24, and 52 weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream. Information about any side effects that may occur will also be collected.
This study will also evaluate how the study drug reacts in the body when given once a day for 12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is complete. The relationship between study drug and the results from the how the study drug reacts in the body may be explored, if needed.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Daytona Beach, Florida, 미국, 32117
- Covance Clinical Research Inc
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Texas
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Dallas, Texas, 미국, 75247
- Covance
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Wisconsin
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Madison, Wisconsin, 미국, 53704
- Covance Clinical Research Inc
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Generally healthy participants or have stable medical conditions that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data and meets one of the following criteria:
- Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams per deciliter (mg/dL), OR
- Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less than 50 mg/dL (women), OR
- Hypercholesterolemia on stable statin therapy for at least 3 month
- Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2), inclusive, at screening
Exclusion Criteria:
- Have known allergies or intolerance to evacetrapib, related compounds
- Have history of recurrent rashes or chronic skin conditions
- Have significant history of or current chronic, active inflammatory conditions
- Have history or current evidence of significant neurological disorder
- Have long-standing diabetes that is insulin requiring
- Have history of or current symptoms of malabsorption syndromes, history of gastric bypass surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Evacetrapib: Single Dose
Single oral dose of evacetrapib on Day 1
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구두로 관리
다른 이름들:
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실험적: Evacetrapib: Multiple Dose 12 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 12 consecutive weeks
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구두로 관리
다른 이름들:
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실험적: Evacetrapib: Multiple Dose 24 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 24 consecutive weeks
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구두로 관리
다른 이름들:
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실험적: Evacetrapib: Multiple Dose 52 Weeks
Evacetrapib administered orally once daily beginning on Day 8 for 52 consecutive weeks
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구두로 관리
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])
기간: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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PK Parameters of Evacetrapib: Maximum Concentration (Cmax)
기간: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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PK Parameters of Evacetrapib: Terminal Half-life
기간: Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose
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2차 결과 측정
결과 측정 |
기간 |
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PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level
기간: Day -1, Day 8
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Day -1, Day 8
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PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level
기간: Day -1, Day 8
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Day -1, Day 8
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PD Parameters of Evacetrapib: Total Cholesterol Level
기간: Day -1, Day 8
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Day -1, Day 8
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PD Parameters of Evacetrapib: Triglyceride Level
기간: Day -1, Day 8
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Day -1, Day 8
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 15340
- I1V-MC-EIBM (기타 식별자: Eli Lilly and Company)
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