- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00500201
A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets.
2017년 8월 5일 업데이트: GlaxoSmithKline
A Single Blind, Double Dummy, Placebo Controlled, Randomized, 2 Period Crossover Study to Assess the Relative Bioavailability of a 120mg Tablet Compared to Two 60 mg SB-773812 Tablets in Healthy Volunteers
Study to compare PK of a new 120mg tablet with two 60mg tablets.
This is required because we plan to have only single tablets administered in the later phase clinical trials but we have not had a 120mg strength before.
As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 2x60mg before we start a large manufacturing campaign and before we administer to a large number of patients.
The study is planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of 18 subjects.
There will be 20 days washout between each dose.
Initially 4 subjects will be given a single oral dose of 120 mg SB-773812 and 2 will be given placebo.
If 120mg SB-773812 is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed.
If the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be stopped.
Subjects will return to the centre for follow-up 14 to 21 days after the final dose.It is expected that the total duration of the study should be approximately 11 weeks.
연구 개요
연구 유형
중재적
등록 (실제)
18
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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London, 영국, NW10 7NS
- 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 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- be a healthy man or woman, aged 18 to 55, and be neither too fat nor too thin;
- If you are a woman who can have a baby, you must use an acceptable method of contraception, from the start of your last period before you take the study medicine, until you've had your first normal period after the end of the study. You might need to use contraception for longer than that. You don't need to use contraception if your partner has been sterilized (had an operation to cut the tubes that carry sperm).
- Acceptable methods of contraception for women are:
- Diaphragm or cap and condom with spermicide;
- the 'Pill' and condom with spermicide - you must have been taking the 'Pill' for at least 3 months before the start of the study;
- Intrauterine device (IUD or 'coil' - your GP must confirm that you have one) and condom with spermicide; or
- Condom and spermicide only, if you're a woman who has had an operation to have your tubes tied.
- If you are a woman who CANNOT have a baby, you should have gone through menopause at least 1 year ago;
- had your womb removed; or
- had both ovaries removed.
- have normal physical exam
- have normal blood pressure and pulse.
- be able to swallow tablets;
- show proof of identity - we'll tell you what's suitable.
- have the ability to understand and comply with protocol requirements, instructions and restrictions.
- be available to attend the ward for repeat tests, if necessary, during the 2 weeks after your final planned visit.
Exclusion Criteria:
- abuse alcohol or drugs;
- drink, on average, more than 3 units of alcohol daily if you're a man, or 2 units if you're a woman (1 unit = ½ pint of beer, 1 small glass of wine or 1 measure of spirits);
- have been a blood donor in the last 3 months;
- have been given an experimental medicine in the last 3 months;
- have taken part in a study of an experimental medicine in the last 3 months;
- be a smoker, or have smoked cigarettes or used other tobacco products regularly in the last 6 months - we may test your breath for smoking at any time during the study;
- be pregnant or breast feeding;
- have had a serious reaction to any medicine;
- have any screening test results that show you're not suitable, even if they don't mean that you're unhealthy;
- have had any important illness (including diabetes and asthma) that, in the opinion of the study doctor, makes you unsuitable for the study;
- have had any mental illnesses;
- suffer from numbness or tingling in your arms, legs, hands or feet; or
- has had glaucoma (increased pressure inside the eye).
- You may not be able to take part if you've taken any medicines recently, including herbal remedies like St John's wort.
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: 크로스오버 할당
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Subjects in treatment sequence AB
In treatment sequence AB first subjects will be randomized to receive treatment A (two tablets of 60 milligram [mg] of SB-773812) and one placebo tablet.
Then subjects will receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets .
There will be a wash-out period of 20 days between.
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SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
다른 이름들:
SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
Placebo tablets will be administered orally by subjects.
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실험적: Subjects in treatment sequence BA
In treatment sequence BA first subjects will be randomized to receive treatment B (one tablet of 120 mg of SB-773812) and two placebo tablets.
Then subjects will receive treatment A (two tablets of 60 mg of SB-773812) and one placebo tablet.
There will be a wash-out period of 20 days between.
|
SB- 773812 will be available dose strength of 60 mg and administered orally by subjects.
다른 이름들:
SB- 773812 will be available dose strength of 120 mg and administered orally by subjects.
Placebo tablets will be administered orally by subjects.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Blood sampling over a period 336 hrs post SB773812 dosing in both dosing sessions.
기간: 336 hrs post SB773812 dosing
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336 hrs post SB773812 dosing
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2차 결과 측정
결과 측정 |
기간 |
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Safety: ECG, vital signs, clinical labs over 336 hours post SB-773812 dosing in both dosing sessions.
기간: 336 hours post SB-773812 dosing
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336 hours post SB-773812 dosing
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Continuous adverse event monitoring from dosing until study conclusion and follow up, 7-14days after last dose.
기간: 7-14days after last dose
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7-14days after last dose
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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)
2007년 5월 24일
기본 완료 (실제)
2007년 7월 25일
연구 완료 (실제)
2007년 7월 25일
연구 등록 날짜
최초 제출
2007년 7월 10일
QC 기준을 충족하는 최초 제출
2007년 7월 10일
처음 게시됨 (추정)
2007년 7월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 8월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 8월 5일
마지막으로 확인됨
2017년 8월 1일
추가 정보
이 연구와 관련된 용어
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. .