- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02006537
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
2017년 5월 5일 업데이트: GlaxoSmithKline
A Study to Evaluate the Effect of Age, Food and Gender on Tolerability and Pharmacokinetics of GSK2256294 Following a Single Oral Administration in Healthy Fed and Fasted Elderly Subjects. This Study Will Also Evaluate the Biliary Metabolites in Healthy Young Males Following a Single Dose of GSK2256294
This study will investigate the safety and pharmacokinetics (PK) of a single dose of GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and age on drug exposure.
The biliary metabolites in healthy young males will be investigated using the Entero-test after a single oral dose of GSK2256294.
This study will be conducted in two cohorts (Cohort 1 and Cohort 2).
Cohort 1 is open label in order to characterise the PK profile of GSK2256294 in healthy young males and also to investigate the biliary metabolites of GSK2256294.
Cohort 2 uses a crossover design to allow comparison of the PK parameters of GSK2256294 between in the fed and fasted state within subject and also to compare the PK parameters of GSK2256294 between male and female subjects.
A washout period of a minimum of 2 weeks has been chosen to allow and adequate washout of GSK2256294.
연구 개요
연구 유형
중재적
등록 (실제)
28
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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Maryland
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Baltimore, Maryland, 미국, 21225
- GSK Investigational Site
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Safety - All Cohorts
- 12 lead ECG without any clinically significant abnormality as judged by the Investigator, and ECGs QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 milliseconds (msec) determined by the average of triplicate ECGs.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 2 weeks post-last dose.
- Body weight >=60 kilogram (kg) and body mass index (BMI) within the range 19 - 35 kg per meter square (kg/m^2) (inclusive).
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5xUpper limit of normal [ULN] (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter outside the reference range for the population being studies may be included only of the Investigator agree that the finding is unlikely to introduce additional risk factors and will not interfere with study procedures. Consultation with the GSK Medical Monitor is required.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Safety - Cohort 2 Only
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international units per milliliter (mIU/mL) and estradiol <40 picogram per milliliter (pg/mL) (<147 picomole per liter) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods listed in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]
- Other - Cohort 1 Only.
- Cohort 1 only: Male aged between 18 and 45 years of age inclusive, at the time of signing the informed consent.
Cohort 1 only: BP <=130/80.
- Other - Cohort 2 Only
- Cohort 2 only: Male and females (of non-child bearing potential) aged >=60 years of age, at the time of signing the informed consent.
- Cohort 2 only: BP <=160/100.
Exclusion Criteria:
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for human immunodeficiency virus (HIV) antibody.
- A positive pre-study drug/alcohol screen.
- Subjects with a history of any type of malignancy with the exception of successfully treated squamous cell cancer of the skin.
- History of sensitivity to the study medication, or components thereof or a history of drug allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicated their participation.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
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: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cohort 1
Cohort 1 will enrol 8 healthy male volunteers, who will receive a single 10 mg dose of GSK225694 in the fasted state.
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GSK2256294 is a 5 mg capsule administered orally as a 10 mg dose in the fasted or fed state
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실험적: Cohort 2
Cohort 2 will enrol 20 healthy elderly male and female volunteers (10 males and 10 females), who will receive a single 10 mg dose of GSK225694 in the fasted or fed state according to the randomization schedule.
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GSK2256294 is a 5 mg capsule administered orally as a 10 mg dose in the fasted or fed state
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cohort 2: PK profiles of a single oral dose of GSK2256294
기간: Pre-dose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1) and 24 h (Day 2), 48 h (Day 3) and 72 h (Day 4)
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PK parameters including area under the concentration-time curve (AUC) and maximum blood concentrations (Cmax), half life (T1/2), time to Cmax (Tmax) following a single oral dose of GSK2256294 administered under fed and fasted conditions in healthy elderly male and female subjects will be estimated
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Pre-dose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1) and 24 h (Day 2), 48 h (Day 3) and 72 h (Day 4)
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Cohort 2: Electrocardiogram (ECG) as a measure of safety and tolerability
기간: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Twelve-lead ECGs will be obtained as a measure of safety and tolerability
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Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Cohort 2: Adverse events (AEs ) as a measure of safety and tolerability
기간: From the start of study treatment and until approximately 2 weeks after the final dose
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From the start of study treatment and until approximately 2 weeks after the final dose
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Cohort 2: Vital signs as a measure of safety and tolerability
기간: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate
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Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Cohort 2: Laboratory assessments as a measure of safety and tolerability
기간: Screening and follow-up. In addition, clinical chemistry will also be done at 12 h (Day 1) and 24 h (Day 2)
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Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
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Screening and follow-up. In addition, clinical chemistry will also be done at 12 h (Day 1) and 24 h (Day 2)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cohort 1: Biliary metabolite profile of GSK2256294
기간: Until 7 hours post-dose on Day 1
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Bile will be collected for metabolic analysis of GSK2256294 + metabolites via the use of the Entero-Test capsule in healthy male younger subjects
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Until 7 hours post-dose on Day 1
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Cohort 1: AEs as a measure of safety and tolerability
기간: From the start of study treatment and until approximately 2 weeks after the final dose
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From the start of study treatment and until approximately 2 weeks after the final dose
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Cohort 1: ECG as a measure of safety and tolerability
기간: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Twelve-lead ECGs will be obtained to assess safety and tolerability
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Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Cohort 1: Vital signs as a measure of safety and tolerability
기간: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Vital sign measurements will include systolic and diastolic BP and pulse rate
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Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
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Cohort 1: Laboratory assessments as a measure of safety and tolerability
기간: Screening and follow-up
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Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
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Screening and follow-up
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Cohort 1 and Cohort 2: AUC, Cmax, t1/2,and Tmax of GSK2256294
기간: Cohort 1: Pre-dose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 7 h, 12 h and 24 h, 48 h, and 72 h; Cohort 2: Pre-dose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 24 h, 48 h and 72 h
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To compare the pharmacokinetic profiles of single oral doses of GSK2256294 in healthy elderly and healthy younger subjects, and between healthy elderly male and female subjects
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Cohort 1: Pre-dose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 7 h, 12 h and 24 h, 48 h, and 72 h; Cohort 2: Pre-dose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 24 h, 48 h and 72 h
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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)
2014년 1월 31일
기본 완료 (실제)
2014년 5월 27일
연구 완료 (실제)
2014년 5월 27일
연구 등록 날짜
최초 제출
2013년 12월 5일
QC 기준을 충족하는 최초 제출
2013년 12월 5일
처음 게시됨 (추정)
2013년 12월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 5월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 5일
마지막으로 확인됨
2017년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 117023
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
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주석이 달린 사례 보고서 양식
정보 식별자: 117023정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 117023정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 117023정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 117023정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 117023정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 117023정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 117023정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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. .
GSK2256294에 대한 임상 시험
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