A Study of 123I-CMICE-013 Radiopharmaceutical in Healthy Volunteers (CMICE)
A Phase 1 Study of Safety, Tolerance, Pharmacokinetics and Nuclear Medicine Imaging of 123I-CMICE-013 Administered Intravenously in Healthy Adult Volunteers
연구 개요
상세 설명
Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is an established, cost effective tool for the risk stratification and management of patients suspected or known to have coronary artery disease (CAD)Myocardial perfusion imaging is significantly affected by interruptions in the supply of 99mMo, the parent isotope of 99mTc used for the majority of MPI. An alternative radiotracer, I123-CMICE-013,developed at the Canadian Molecular Imaging Center of Excellence (C-MICE) at the University of Ottawa Heart Institute, has completed pre-clinical trial testing and is ready for Phase 1 human trials.
This Phase I study will be a single centre, open label study. Subjects will receive 2 doses of study drug. One rest dose and one stress dose will be administered on separate days, one week apart. Subjects will undergo a standard clinical exercise stress protocol for the stress dose. Gamma camera imaging following each administration will be done over 2 days.
Biodistribution, pharmacokinetics, dosimetry and safety variables will be analyzed.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1Y 4W7
- University of Ottawa Heart Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 18 and 65 years
- No significant medical history
- Normal physical exam
- BMI ≤ 30 kg/m2
- No current use of prescription medication
- No clinically significant abnormalities in baseline laboratory work
- No clinically significant abnormalities in baseline 12 lead electrocardiogram
- Female subjects must be post-menopausal, surgically sterilized or have negative urine beta human chorionic gonadotropin pregnancy test at initial screening
Exclusion Criteria:
- Pregnancy
- Known hypersensitivity to the investigational drug or any of its components
- Claustrophobia or inability to lie still in a supine position
- Unwillingness to provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 123I-CMICE-013
Administration and analysis of alternative MPI radiotracer
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2 intravenous doses of drug will be given one week apart.
Doses will be equivalent to 1 rest dose and 1 stress dose.
Serial nuclear imaging will follow dose injections.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Biodistribution
기간: 0 to 24 hours post injection
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Quantitative in vivo biodistribution will be determined through whole-body planar imaging immediately and at 90 mins, 4 hrs, 6 hrs and 24 hrs post injection. Venous blood samples of 10 ml volume each will be taken at nominal times of 5, 10, 15, 30, 60, 90 and 180 minutes post administration and at 6 and 24 hours and activity measured. Urine and faeces as voided up to 24 hrs post administration will be assayed. Internal radiation dose, Effective Dose Equivalent (ICRP 30), Effective Dose (ICRP 60) and organ residence times will be calculated. |
0 to 24 hours post injection
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Safety/Tolerability
기간: 0 to 7 days post injection
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Adverse events and Serious Adverse Events will be recorded and reported.
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0 to 7 days post injection
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공동 작업자 및 조사자
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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