Succinate Salt Version of GSK961081 for Healthy Volunteers
2021년 9월 28일 업데이트: Theravance Biopharma
A Randomised, Double-blind, Dose Escalating Study in Healthy Volunteers to Assess the Safety, Tolerability, Extra Pulmonary Pharmacodynamics and Pharmacokinetics of Single Doses of GSK961081 (Succinate Salt)
Salt Bridging study for GSK961081
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
남성
설명
Inclusion Criteria:
- Healthy adult males or female aged between 18 and 50 years.
- Body mass index within the range 19-29.9 kilograms/metre2
- Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
- Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.
Exclusion criteria:
- Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
- History of respiratory disease
- Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
- Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
- Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
- Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
- Infected with the Hepatitis B, Hepatitis C, or HIV virus
- Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
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: Sequence 1
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
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GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
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실험적: Sequence 2
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
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GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
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실험적: Sequence 3
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
실험적: Sequence 4
In session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
실험적: Sequence 5
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
실험적: Sequence 6
In session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
실험적: Sequence 7
In session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
|
|
실험적: Sequence 8
In session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
|
GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams.
GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms.
The dose of GSK961081 edisylate is 1500 micrograms.
GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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FEV1 at intervals
기간: during the 10 week study
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during the 10 week study
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Cardiac monitoring at intervals
기간: during the 10 week study
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during the 10 week study
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2차 결과 측정
결과 측정 |
기간 |
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Plasma concentrations of GSK961081 at intervals
기간: during the 10 week study
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during the 10 week study
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PK parameters at intervals
기간: during the 10week study
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during the 10week study
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
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)
2007년 11월 29일
기본 완료 (실제)
2008년 1월 8일
연구 완료 (실제)
2008년 1월 8일
연구 등록 날짜
최초 제출
2007년 10월 26일
QC 기준을 충족하는 최초 제출
2007년 10월 26일
처음 게시됨 (추정)
2007년 10월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 10월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 28일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MAB108115
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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개별 참가자 데이터 세트
정보 식별자: MAB108115정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: MAB108115정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: MAB108115정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: MAB108115정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: MAB108115정보 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: MAB108115정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: MAB108115정보 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. .
GSK961081에 대한 임상 시험
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Theravance BiopharmaGlaxoSmithKline; Hammersmith Medicines Research완전한
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Theravance BiopharmaGlaxoSmithKline완전한
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GlaxoSmithKline완전한폐질환, 만성 폐쇄성독일, 루마니아, 우크라이나, 에스토니아, 러시아 연방, 남아프리카, 스웨덴, 네덜란드, 슬로바키아