- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02586194
Pharmacokinetics Study in Patients With Impaired Hepatic Function
2019년 4월 5일 업데이트: Astellas Pharma Inc
Pharmacokinetic Study of ASP015K - Evaluation of Pharmacokinetics in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function
The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.
연구 개요
연구 유형
중재적
등록 (실제)
24
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Fukuoka, 일본
- Site JP00001
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Kanagawa, 일본
- Site JP00003
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Tokyo, 일본
- Site JP00006
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Tokyo, 일본
- Site JP00004
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Tokyo, 일본
- Site JP00005
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Tokyo, 일본
- Site JP00002
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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
20년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
A subject is eligible for the study if all of the following apply:
All subjects:
- Body weight: ≥40.0 kg and <90.0 kg
- Body mass index (BMI): ≥17.0 and <30.0 kg/m2
Female subject must either:
- Be post-menopausal or surgically sterile.
- Agree not to try to become pregnant starting at the time of informed consent throughout the study period and for 60 days after the final study drug administration if she is of childbearing potential.
- Agrees to use highly effective contraception
- Agrees not to donate sperm (for male)/ ova (for female) starting at the time of informed consent, and throughout the study period and for 90/60 days after the final study drug administration.
- Female subject agrees not to breastfeed starting at the time of informed consent, and throughout the study period and for 60 days after the final study drug administration.
- Agrees not to participate in a clinical trial, a post-marketing study, or a clinical study during the period from informed consent to post examination.
A patient with impaired hepatic function:
- Impaired hepatic function Child-Pugh Score Class A (mild, 5-6 points) or Class B (moderate, 7-9 points).
A subject with normal hepatic function:
- Healthy, as judged by the investigator/subinvestigator based on physical examinations and all tests obtained at screening and during the period from hospital admission to immediately before study drug administration.
Exclusion Criteria:
A subject will be excluded from participation in this study if any of the following apply:
All subjects:
- Received or is scheduled to receive any investigational drugs in other clinical trials, post-marketing studies or clinical research within 120 days before screening or during the period from screening to the hospital admission.
- Excessive alcohol or smoking habit.
Applies to any of following concerns of tuberculosis:
- A history of active tuberculosis
- Abnormalities detected on a chest X-ray test (at screening)
- Contact with infectious tuberculous patients
Applies to any of following concerns except for tuberculosis:
- Concurrent or previous severe herpes zoster or herpes zoster disseminated
- More than 1 recurrence of localized herpes zoster
- Inpatient hospital care for severe infectious disease within 90 days before the hospital admission
- Treatment with intravenous antibiotics within 90 days before the hospital admission (prophylactic antibiotics are not applicable)
- Other than above, a people who has a risk of developing infectious diseases (e.g. urethral catheterisation) in judgment of the investigator/subinvestigator
- Vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission (inactivated vaccines such as influenza vaccine and pneumococcal vaccine are not applicable).
- Concurrent or previous drug allergies.
- A history of clinically serious allergies (serious allergies: Generalised urticaria which requires hospital admission, allergy which causes anaphylactic shock, etc.).
- Concurrent or previous cardiac failure NYHA class 3 or 4, long QT syndrome and congenital short QT syndrome.
- Development of (an) upper gastrointestinal symptom(s) within 7 days before the hospital admission.
- Concurrent or previous lymphatic disease.
- A history of digestive tract excision, except for a history of appendectomy.
- Previous use of ASP015K.
A patient with impaired hepatic function:
- Unable to start washout of concomitant prohibited medications from at least 14 days prior to the study drug administration.
- Concurrent uncontrolled hypertension.
- Clinically significant abnormality detected on standard 12-lead electrocardiogram at screening or hospital admission.
- eGFR by the GFR estimating equation for Japanese <45 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
- Uncontrolled ascites or pleural effusion observed at screening.
- Concurrent hepatic encephalopathy Coma Scale II or more at screening.
- Underwent hepatic transplantation, or underwent hepatectomy within 1 year before screening.
- Concurrent or previous drug-induced hepatic disorder.
- Concurrent acute hepatic disease.
- With surgically-placed portosystemic shunts including transjugular intrahepatic portosystemic shunts.
- Concurrent biliary obstruction.
- A history of oesophageal haemorrhage or gastric varices haemorrhage within 180 days before screening.
- Irregular or acute, and clinically significant LFT values or changes in clinical symptoms from 30 days before screening to immediately before study drug administration.
- Platelet count <4 × 104/μL, or haemoglobin <9 g/dL at screening.
- Alcohol dependence or unable to remain abstinent during the specified period.
- Concurrent esophagus or gastric varices which have a high risk of clinically significant haemorrhage.
- Concurrent cerebrovascular disorder, serious heart disease, malignant tumour or a history within 5 years before screening, gastrointestinal disease, urinary disease, renal disease, endocrine disease, and respiratory disease.
A subject with normal hepatic function:
- Received or is scheduled to receive medications (including over-the-counter drugs) within 7 days before the hospital admission.
- Deviates from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or the hospital admission.
- Meets any of the criteria for laboratory tests at screening or the hospital admission.
- eGFR by the GFR estimating equation for Japanese <60 mL/min/1.73 m2 (the first decimal place rounded off) at screening.
- Concurrent or previous hepatic disease, cerebrovascular disorder, malignant tumor, heart disease, gastrointestinal disease, except for a history of appendicitis, renal disease, endocrine disease, respiratory disease, urological disease.
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: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Control (Subjects with normal hepatic function)
Oral
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Oral
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실험적: Mild hepatic impairment
Oral
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Oral
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실험적: Moderate hepatic impairment
Oral
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Oral
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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활력징후로 안전성 평가
기간: 연구 약물 투여 후 최대 7일
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앙와위 혈압, 앙와위 맥박수 및 겨드랑이 체온
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연구 약물 투여 후 최대 7일
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실험실 테스트에 의해 평가된 안전성
기간: 연구 약물 투여 후 최대 7일
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혈액학, 혈액 생화학 및 소변 검사
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연구 약물 투여 후 최대 7일
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Pharmacokinetics (PK) parameter of ASP015K: AUCinf
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72 hr after dosing
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AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72 hr after dosing
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PK parameter of ASP015K: Cmax
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Cmax: Maximum concentration
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameter of metabolites: AUCinf
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameter of metabolites: Cmax
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Safety assessed by AEs
기간: Up to 7 days after the study drug dosing
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Up to 7 days after the study drug dosing
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Safety assessed by 12-lead ECGs
기간: Up to 7 days after the study drug dosing
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Up to 7 days after the study drug dosing
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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PK parameters of ASP015K: AUClast
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameters of ASP015K: t1/2
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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t1/2: Terminal elimination half-life
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameters of ASP015K: tmax
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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tmax: Time of Cmax
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameters of ASP015K: CL/F
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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CL/F: Apparent total systemic clearance
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameters of ASP015K: Vz/F
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Vz/F: Apparent volume of distribution during the terminal elimination phase
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameters of metabolites: AUClast
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameters of metabolites: t1/2
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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PK parameters of metabolites: tmax
기간: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (실제)
2015년 12월 28일
기본 완료 (실제)
2016년 9월 27일
연구 완료 (실제)
2016년 9월 27일
연구 등록 날짜
최초 제출
2015년 10월 23일
QC 기준을 충족하는 최초 제출
2015년 10월 23일
처음 게시됨 (추정)
2015년 10월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 4월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 5일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 015K-CL-PK10
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
ASP015K에 대한 임상 시험
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Astellas Pharma Global Development, Inc.완전한
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Astellas Pharma Inc완전한건강한 과목 | ASP015K의 생체이용률 | ASP015K의 약동학미국
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Astellas Pharma Inc완전한건강한 과목 | 약력학 | ASP015K의 약동학미국
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Astellas Pharma Inc완전한
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Astellas Pharma Inc완전한
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Astellas Pharma Inc완전한건강한 과목 | ASP015K의 생체이용률 | ASP015K의 약동학미국
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Astellas Pharma Inc완전한건강한 자원봉사자 | ASP015K의 약동학일본