A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Administration of Multiple Ascending Doses for 8 Days in Healthy Male or Female Subjects
The purpose of this study is to explore the safety and tolerability of AZD5069 at steady-state, following twice a day oral dosing in healthy subjects.
AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females at different dose levels over an 8-day dosing period. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3 dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 10 nights and a follow up.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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London Bridge, 영국
- Research Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Provision of signed and dated, written informed consent
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
- Healthy male or female (of non child bearing potential)volunteers with suitable veins for cannulation or repeated venepuncture
Exclusion Criteria:
- Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate
- Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
- Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
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oral suspension dose of AZD5069.
Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
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위약 비교기: 2
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oral suspension dose of matched placebo.
Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry
기간: Baselines assessments at Visit 1 (enrolment) or pre-dose on Day 1 with assessments during Visit 2 at protocol defined time-points post-dose until 96hr post final dose. Follow up assessments at Visit 3
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Baselines assessments at Visit 1 (enrolment) or pre-dose on Day 1 with assessments during Visit 2 at protocol defined time-points post-dose until 96hr post final dose. Follow up assessments at Visit 3
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2차 결과 측정
결과 측정 |
기간 |
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Pharmacokinetic profile: concentration of AZD5069 in blood
기간: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood
기간: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Measurement of the effect of AZD5069 on blood cells
기간: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Darren Wilbraham, MBBS, DCPSA, Quintiles, Inc.
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- D3550C00007
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AZD5069에 대한 임상 시험
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AstraZeneca완전한과학 용어 만성 폐쇄성 폐질환(COPD) | 평신도 용어 만성 기관지염 및 폐기종불가리아, 독일, 헝가리, 우크라이나
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AstraZeneca완전한천식불가리아, 체코 공화국, 멕시코, 폴란드, 러시아 연방, 남아프리카, 영국, 독일, 루마니아, 우크라이나, 캐나다, 헝가리, 슬로바키아
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AstraZenecaQuintiles, Inc.완전한
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Institute of Cancer Research, United KingdomAstraZeneca; Astellas Pharma Inc; Prostate Cancer UK종료됨