- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02878096
Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study
2016년 10월 12일 업데이트: Sanwa Kagaku Kenkyusho Co., Ltd.
An Open-Label, 2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-SK-1404 Administered to Healthy Male Subjects
The primary objectives of the study are:
- To determine the absolute bioavailability of SK-1404
- To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404
- To provide plasma, urine and faecal samples for metabolite profiling and structural identification
The secondary objectives of the study are:
- To determine the routes and rates of elimination of [14C]-SK-1404
- To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity
- To explore the intravenous (IV) pharmacokinetics (PK) of [14C]-SK-1404
- To further explore the PO PK of SK-1404
- To provide additional safety and tolerability information for SK-1404
연구 개요
상세 설명
This is a single-centre, 2-part, open-label, non-randomised, sequential, single dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects who will participate in Parts 1 and Part 2 of the study.
In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.
In Part 2, each subject will receive a single PO dose of [14C]-SK-1404.
연구 유형
중재적
등록 (실제)
6
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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Nottingham
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Ruddington, Nottingham, 영국, NG11 6JS
- Quotient Clinical
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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
30년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- Healthy males
- Age 30 to 65 years of age
- Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
- Must agree to use an adequate method of contraception
Exclusion Criteria:
- Males with pregnant partners
- Participation in a clinical research study within the 3 months prior to IMP dose
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- Subjects who have previously been dosed with SK-1404
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) in the past year
- Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Subjects who have been enrolled in an ADME study in the last 12 months
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1)
- Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase >1.5 × upper limit of normal confirmed by repeat testing
- Serum sodium below the lower limit of normal
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: [14C]-SK-1404
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In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Absolute bioavailability (F) calculated with the AUC values of IV administration in Part 1 and PO administration in Part 2
기간: Predose to 96hr
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Predose to 96hr
|
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Mass balance recovery of total radioactivity in urine, faeces and all excreta
기간: Predose to 168hr
|
Amount excreted (Ae), and Ae as a percentage of the administered dose (%Ae), cumulative recovery (Cum Ae) and cumulative recovery expressed as a percentage of the dose (Cum %Ae)
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Predose to 168hr
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Number and structural identification of known and unknown metabolites of SK-1404 in the plasma, urine and faeces samples
기간: Predose to 168hr
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Predose to 168hr
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
기간: Predose to 168hr
|
Predose to 168hr
|
|
%Ae total radioactivity in plasma by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
기간: Predose to 168hr
|
Predose to 168hr
|
|
Cum Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
기간: Predose to 168hr
|
Predose to 168hr
|
|
Cum %Ae (total) for urine by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
기간: Predose to 168hr
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Predose to 168hr
|
|
Cum Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
기간: Predose to 168hr
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Predose to 168hr
|
|
Cum %Ae (total) for faeces by metabolite profiling and structural identification to estimate the routes and rates of elimination of [14C]-SK-1404
기간: Predose to 168hr
|
Predose to 168hr
|
|
Number and structural identification of unknown metabolites of SK-1404 with an AUC of more than 10% of circulating total radioactivity
기간: Predose to 168hr
|
Predose to 168hr
|
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The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 96hr
|
The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
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The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The apparent volume of distribution (Vd) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The apparent volume of distribution (Vss) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
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Predose to 96hr
|
The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after IV SK-1404
기간: Predose to 96hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 96hr
|
The peak plasma concentration (Cmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The time from dosing at which Cmax was apparent (Tmax) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The elapsed time from dosing at which the analyte was first quantifiable in a concentration vs time profile (Tlag) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The area under the concentration-time curve from dosing to the last measurable concentration (AUC(0-last)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The area under the concentration-time curve from dosing extrapolated to infinity (AUC(0-inf)) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The percentage of AUC(0-inf) extrapolated beyond the last measured time point (AUC%extrap) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The terminal elimination rate constant calculated from the slope of the apparent elimination phase (lambda-z) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The apparent terminal elimination half-life (T1/2) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The absolute bioavailability (F, PO vs IV from Part 1) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The apparent total clearance (CL/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The apparent volume of distribution (Vd/F) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
The mean residence time (MRT) of SK-1404F and its active metabolites M-1, M-7 and M-9) after PO SK-1404
기간: Predose to 168hr
|
Metabolite:parent ratios will be calculated for SK-1404F, M-1, M-7 and M-9
|
Predose to 168hr
|
To collect further information about the safety and tolerability of IMP
기간: Predose to 168hr
|
By assessing physical examination, safety laboratory tests, vital signs, electrocardiograms (ECGs) and AEs.
|
Predose to 168hr
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Litza McKenzie, MBChB BScMedSci, Quotient Clinical
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
2016년 7월 1일
기본 완료 (실제)
2016년 8월 1일
연구 완료 (실제)
2016년 8월 1일
연구 등록 날짜
최초 제출
2016년 8월 5일
QC 기준을 충족하는 최초 제출
2016년 8월 19일
처음 게시됨 (추정)
2016년 8월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 10월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 10월 12일
마지막으로 확인됨
2016년 10월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .
[14C]-SK-1404에 대한 임상 시험
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Molecular Insight Pharmaceuticals, Inc.완전한전립선암미국, 벨기에, 이탈리아, 체코 공화국, 헝가리, 네덜란드, 폴란드, 러시아 연방
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Molecular Insight Pharmaceuticals, Inc.완전한
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Molecular Insight Pharmaceuticals, Inc.완전한
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Molecular Insight Pharmaceuticals, Inc.완전한
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Molecular Insight Pharmaceuticals, Inc.완전한
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Molecular Insight Pharmaceuticals, Inc.완전한