- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01713608
A Dose-escalation Study to Investigate Safety and Toleration of OZ439
2015년 3월 12일 업데이트: Medicines for Malaria Venture
A Randomised, Placebo-controlled, Dose-escalation Study to Investigate Safety and Toleration of OZ439 OD for 3 Days to Healthy Male and Female Volunteers
A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:
- To determine the safety and tolerability of ascending doses of OZ439 OD for three days.
- To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.
- To identify the maximum tolerated dose of OZ439 administered.
연구 개요
상세 설명
This study will be conducted in a randomised, placebo-controlled dose-escalation design with OZ439 OD administered with full fat milk for three days to healthy male and female subjects between 18 to 55 years of age, using features of an adaptive study design.
The study is expected to have three cohorts with a total of 36 healthy male and female subjects.
An additional two cohorts may be used if required.
The results of this study will inform the maximum tolerated exposure of OZ439 following OD dosing for three days in subjects who are not fasted.
연구 유형
중재적
등록 (실제)
34
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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Croydon, 영국, CR77YE
- Richmond Pharmacology Ltd
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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
아니
연구 대상 성별
모두
설명
Inclusions:
- healthy males or females of any race aged 18 - 55 years
- BMI of 18 - 30 kg/m2 inclusive at screening
- Agree to use acceptable methods of contraception if of childbearing potential
- Capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form
- Females are either of child bearing potential or are confirmed as post-menopausal. Post-menopausal is defined as being amenorrheic for 12 months without an alternative medical cause with a screening FSH level ≥ 25.8 IU/L
Exclusions:
- Male subjects with female partner(s) who is (are) pregnant or lactating from the time of the first administration of study medication
- Clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion
- History of allergic reactions to artemisinin-based compounds or any other clinically relevant allergy to drugs or food
- Clinically relevant history of both soya and cow's milk intolerance/allergy
- Clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission
- Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) and/or 24-hour 5 lead Holter ECG (at screening)
- Any abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes
- Prolonged QTcF >450 ms or shortened QTcF <340 ms, or family history of Long QT Syndrome
- History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease
- Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti Hepatitis core antibody (anti HBc Ig G [and anti HBc IgM if IgG is positive], Hepatitis C antibodies (anti HCV), and HIV 1 and 2 antibodies (anti HIV 1/2)
- Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates, and methadone) or from the alcohol breath test at screening and on admission
- History or clinical evidence of alcohol or drug abuse. Alcohol abuse is defined as regular weekly intake of more than 21 units for males and 14 units for females; drug abuse is defined as compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms
- Is pregnant or lactating (female subjects who are of childbearing potential must have negative pregnancy tests at screening and admission)
- Mentally handicapped
- Participation in a drug trial within 90 days prior to first drug administration
- Use of any medication (incl. over-the-counter (OTC) medication) within 2 weeks prior to drug administration (Day 1) or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment periods, (whichever is longer), including herbal, traditional and alternative medications. Excluding oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants. Limited amounts (4g/day for 2 days) of paracetamol will be permitted for the treatment of AEs
- Treatment with herbal supplements during the 7 days prior to drug administration, or use of vitamins during 48 hours prior to drug administration
- Is not permitted to use strong inhibitors and/or inducers of CYP450 within 21 days prior to the planned first drug administration
- Subjects have veins unsuitable for intravenous puncture or cannulation on either arm (e.g. veins that are difficult to locate, access or puncture veins with a tendency to rupture during or after puncture)
- Blood ALT, AST and bilirubin should be in the normal range at screening and on admission
- Donation of more than 500 mL of blood within 90 days prior to drug administration
- Subjects must be non-smokers for at least three months prior to first drug administration
- Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol
- Legal incapacity or limited legal capacity at screening
- Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: OZ439 Dose level 1 (300mg)
• Cohort 1 (12 subjects: 8 Active [A] and 4 on Placebo [P]) Active dose will consist of 300mg OZ439 drinking solution administered once daily for 3 days
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OZ439 x mg once daily for 3 days with milk
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실험적: OZ439 Dose level 2
• Cohort 2 (12 subjects: 8 A, 4P).
Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days
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OZ439 x mg once daily for 3 days with milk
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실험적: OZ439 dose level 3
Cohort 3 (12 subjects: 8 A, 4P).
Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days
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OZ439 x mg once daily for 3 days with milk
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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OZ439 Cmax
기간: Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 maximum measured plasma concentration
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Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 AUCτ
기간: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 Area under the plasma concentration vs time curve from time zero to the time of the last quantifiable concentration t calculated using a log-linear trapezoidal method
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pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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OZ439 Tmax
기간: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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Time to reach maximum measured OZ439 plasma concentration
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pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 t½
기간: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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OZ439 estimated terminal phase half life
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pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Fiona Macintyre, PhD, Medicines for Malaria Venture
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
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
2012년 11월 1일
기본 완료 (실제)
2013년 2월 1일
연구 완료 (실제)
2013년 2월 1일
연구 등록 날짜
최초 제출
2012년 10월 22일
QC 기준을 충족하는 최초 제출
2012년 10월 22일
처음 게시됨 (추정)
2012년 10월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 3월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 3월 12일
마지막으로 확인됨
2015년 3월 1일
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. .
OZ439에 대한 임상 시험
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