- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01299558
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects
2017년 6월 9일 업데이트: GlaxoSmithKline
An Open-label, Non-randomised, Three-way Crossover, Single Dose Study to Determine the Absolute Bioavailability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder, in Healthy Subjects
This study is being done to look at the absolute bioavailability of fluticasone furoate and GW642444 inhalation powder when administered in healthy subjects.
Bioavailability is determined by measuring the amount of the dose of inhaled medication that reaches the circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared to the medication administered intravenously (where bioavailability is 100%).
연구 개요
상세 설명
Fluticasone furoate (FF), a novel glucocorticoid, and GW642444, a potent, inhaled longacting, beta2-receptor agonist (LABA), are currently under development in combination for use as a once-daily, inhaled treatment for asthma and chronic obstructive pulmonary disease (COPD).
FF is also being developed as a stand-alone product for asthma and GW642444 is also being developed as a stand-alone product and in combination with a novel, long-acting muscarinic antagonist for the treatment of COPD.
This study is being performed to determine the absolute bioavailability of both FF and GW642444 when delivered in combination from the novel dry powder inhaler.
연구 유형
중재적
등록 (실제)
16
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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New South Wales
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Randwick, New South Wales, 호주, 2031
- 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:
- Healthy male or female between 18 and 64 years of age inclusive
- Body mass index (BMI) within the range 18.5-29 0 kg/m2 (inclusive)
- Subjects who are current non-smokers
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block, based on a single ECG value, or an average from three ECGs obtained over a brief recording period
- No significant abnormality on the Holter ECG at screening
- FEV1 ≥ 85% predicted at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Subjects who are able to use the inhalation device satisfactorily
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg
- Any history of breathing problems in adult life
- Pregnant or lactating females
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit
- Subjects with recent history (within 6 months) of pneumonia
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
- Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate)
- History of milk protein allergy
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
- The subject has taken oral corticosteroids less than 8 weeks before the screening visit
- The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
- History of alcohol/drug abuse or dependence within 12 months of the study
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject has tested positive for HIV antibodies
- A positive pre-study urine drug screen or when randomly tested during the study
- Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
- Positive urine cotinine test at screening
- Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Treatment period 1
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1
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Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning
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다른: Treatment Period 2
Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2
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Single IV dose of FF (250mcg)
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다른: Treatment Period 3
Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3
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Single IV dose of GW642444 (55mcg)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously
기간: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax, and MRT for all treatments. In addition, volume of distribution (V) and plasma clearance (CL) for intravenous administrations and mean absorption time (MAT) for inhaled treatments
기간: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability
기간: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability
기간: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability
기간: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
기간: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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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)
2010년 5월 17일
기본 완료 (실제)
2010년 7월 15일
연구 완료 (실제)
2010년 7월 15일
연구 등록 날짜
최초 제출
2010년 6월 10일
QC 기준을 충족하는 최초 제출
2011년 2월 17일
처음 게시됨 (추정)
2011년 2월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 6월 9일
마지막으로 확인됨
2017년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 102934
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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통계 분석 계획
정보 식별자: 102934정보 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: 102934정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 102934정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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주석이 달린 사례 보고서 양식
정보 식별자: 102934정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
정보에 입각한 동의서
정보 식별자: 102934정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 102934정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: 102934정보 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. .
fluticasone furoate//GW642444에 대한 임상 시험
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GlaxoSmithKline완전한폐질환, 만성 폐쇄성미국, 아르헨티나, 에스토니아, 캐나다, 칠레, 독일, 페루, 필리핀 제도, 멕시코, 대한민국, 덴마크, 러시아 연방, 폴란드, 슬로바키아
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GlaxoSmithKline완전한
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GlaxoSmithKline완전한천식미국, 독일, 일본, 루마니아, 러시아 연방, 폴란드
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GlaxoSmithKline완전한