- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02536911
A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
An Open-label Pharmacokinetic and Tolerability Study of Eliglustat Tartrate Given as a Single Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function
Primary Objective:
To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of eliglustat.
Secondary Objective:
To assess the tolerability of eliglustat tartrate given as a single dose in subjects with mild and moderate hepatic impairment in comparison with matched subjects with normal hepatic function.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Miami, Florida, 미국, 33014
- Investigational Site Number 840002
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Tennessee
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Knoxville, Tennessee, 미국, 37920
- Investigational Site Number 840001
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria :
For subjects with hepatic impairment:
- Male or female subjects, between 18 and 79 years of age, inclusive.
- Body weight between 50.0 and 125.0 kg, inclusive if male, and between 40.0 and 110.0 kg, inclusive if female, body mass index (BMI) between 18.0 and 37 kg/m^2, inclusive.
- Stable chronic liver disease assessed by medical history, physical examination, laboratory values.
- For moderate hepatic impairment cohort: Child-Pugh total score ranging from 7 to 9, inclusive.
- For mild hepatic impairment cohort: Child-Pugh total score ranging from 5 to 6, inclusive.
For matched subjects:
- Male or female subjects, between 18 and 79 years of age, inclusive.
- Body weight within 15% of the body weight of the subjects with hepatic impairment and BMI between 18.0 and 37 kg/m^2, inclusive.
- Matched by cytochrome P450 (CYP) 2D6 predicted phenotype based on genotype.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
Exclusion criteria:
For subjects with hepatic impairment:
- Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Hepatocarcinoma.
- Acute hepatitis.
- Hepatic encephalopathy grade 2, 3, and 4.
- Presence or history of drug hypersensitivity, or allergic disease, including active seasonal rhinitis, diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day) within 2 years before inclusion.
- If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β -HCG] blood test), breastfeeding.
- P-gp inhibitors and/or inducers, CYP2D6 and/or CYP3A inhibitors and/or inducers.
- Positive result on any of the following tests: anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
- Pre-existing cardiac disease (current congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia), long QT syndrome, or use of Class IA (eg, quinidine, procainamide) and Class III (eg, amiodarone, sotalol) anti-arrhythmic medications.
- Any subject with CYP2D6 indeterminate or ultra-rapid metabolizer (URM) phenotype.
For matched subjects:
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- If female, pregnancy (defined as positive β-HCG blood test), breastfeeding.
- For subjects 50 years of age and younger: any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that medication, whichever the longest, with the exception of hormonal contraception or menopausal hormone replacement therapy, any vaccination within the last 28 days, and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- For subjects older than 50 years of age: any significant change in chronic treatment medication within 14 days before inclusion.
- P-gp inhibitors and/or inducers, CYP2D6 and/or CYP3A inhibitors and/or inducers.
- Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis C virus (anti-HCV) antibodies, anti-HIV1 and anti-HIV2 Ab.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day) within 2 years before inclusion.
- Pre-existing cardiac disease (current congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia), long QT syndrome, or use of Class IA (eg, quinidine, procainamide) and Class III (eg, amiodarone, sotalol) anti-arrhythmic medications.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: GZ385660(건강한 과목)
엘리글루스타트 타르트레이트의 단일 용량은 음식을 섭취한 상태에서 제공됩니다.
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제약 형태: 캡슐 투여 경로: 경구
다른 이름들:
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실험적: GZ385660 (subjects with mild hepatic impairment)
Single dose of eliglustat tartrate will be given under fed conditions
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제약 형태: 캡슐 투여 경로: 경구
다른 이름들:
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실험적: GZ385660 (subjects with moderate hepatic impairment)
Single dose of eliglustat tartrate will be given under fed conditions
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제약 형태: 캡슐 투여 경로: 경구
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Assessment of PK parameter: Maximum plasma concentration observed (Cmax)
기간: 3 days
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3 days
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Assessment of PK parameter: Area under the plasma concentration (AUC)
기간: 3 days
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3 days
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2차 결과 측정
결과 측정 |
기간 |
---|---|
PK 매개변수의 평가: 혈장 농도 대 시간 곡선 아래 면적(AUClast)
기간: 3 일
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3 일
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PK 매개변수의 평가: 겉보기 전신 청소율(CL/F)
기간: 3 일
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3 일
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PK 매개변수의 평가: 말기 동안 분포의 겉보기 용적(Vz/F)
기간: 3 일
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3 일
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PK 매개변수의 평가: 예상 축적 비율(Rac,pred)
기간: 3 일
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3 일
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PK 매개변수의 평가: 말기 반감기(t1/2z)
기간: 3 일
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3 일
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부작용의 수
기간: 최대 10일
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최대 10일
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Change from baseline in ECG parameter
기간: Baseline, Up to 10 days
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Baseline, Up to 10 days
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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
추가 관련 MeSH 약관
기타 연구 ID 번호
- POP13777
- U1111-1170-3678 (기타 식별자: UTN)
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엘리글루스타트에 대한 임상 시험
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