A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects
2014年10月29日 更新者:Astellas Pharma Europe B.V.
A Phase 1, Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male Subjects, Including a Drug-drug Interaction Part With Itraconazole
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of ASP3700 in healthy male subjects.
This study will also explore the effect of itraconazole (another drug) on the PK of ASP3700, as well as to evaluate the safety and tolerability of ASP3700 alone and in combination with itraconazole in healthy male subjects.
研究概览
详细说明
This study consists of 2 parts: Part 1 is a single ascending dose study where subjects will receive either ASP3700 or matching placebo; Part 2 is a drug-drug interaction (DDI) open-label, crossover study comprised of 1 sequence with 2 investigational periods where subjects will receive ASP3700 alone and in combination with itraconazole.
研究类型
介入性
注册 (实际的)
44
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Harrow、英国、HA1 3UJ
- PAREXEL Early Phase Clinical Unit
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Subject has a body mass index range of 18.5 - 30.0 kg/m2. The subject weighs at least 50 kg.
- Subject and his female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continue throughout the clinical study period and for 90 days after the final study drug administration.
- Subject must not donate sperm starting at screening and throughout the clinical study period and for 90 days after the final study drug administration.
Exclusion Criteria:
- Subject has a known or suspected hypersensitivity to ASP3700 (parts 1 and 2) or itraconazole (part 2 only) or significant adverse reactions to historical cannabinoid use or any components of the formulations used.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma-glutamyl transaminase, total bilirubin [TBL]) above the upper limit of normal (ULN). In such a case the assessment may be repeated once (upon admission to the clinical unit).
- Subject has a history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 3 months or who are at significant risk to commit suicide, as judged by the Investigator using the C-SSRS (a level of 4 or 5) at screening or upon admission to the clinical unit.
- Subject has any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests at screening or upon admission to the clinical unit.
- Subject has a pulse rate < 40 or > 90 beats per minute; mean SBP > 140 mmHg; mean DBP > 90 mmHg (vital signs measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse rate will be measured automatically) upon admission to the clinical unit.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) interval > 430 ms at day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken.
- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit.
- Subject has a history of drinking more than 21 units of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit.
- Subject has consumed grapefruit, grapefruit-containing products or Seville orange-containing products within 72 hours prior to admission to the clinical unit.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:ASP3700 single ascending dose cohort
Part 1
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oral
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安慰剂比较:Placebo single ascending dose cohort
Part 1
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口服
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实验性的:ASP3700 alone
Part 2
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oral
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有源比较器:ASP3700 and itraconazole
Part 2
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oral
口服
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety as assessed by adverse events (Part 1)
大体时间:up to end of study visit (up to 16 days)
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up to end of study visit (up to 16 days)
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Safety as assessed by vital signs (Part 1)
大体时间:up to end of study visit (up to 16 days)
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up to end of study visit (up to 16 days)
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|
Safety as assessed by laboratory tests (Part 1)
大体时间:up to end of study visit (up to 16 days)
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Laboratory tests includes the measurement of sex-hormone related biomarkers and exploratory renal biomarkers.
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up to end of study visit (up to 16 days)
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Safety as assessed by electrocardiogram (ECG) measurements (Part 1)
大体时间:up to end of study visit (up to 16 days)
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ECG measurements include routine 12-lead ECG, continuous cardiac monitoring (Holter ECG) and real-time cardiac monitoring (ECG telemetry)
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up to end of study visit (up to 16 days)
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Safety as assessed by Bond and Lader VAS (Part 1)
大体时间:Up to Day 2
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visual analogue scale (VAS)
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Up to Day 2
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Safety as assessed by C-SSRS (Part 1)
大体时间:Up to end of study visit (up to 16 days)
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Columbia - Suicide Severity Rating Scale (C-SSRS)
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Up to end of study visit (up to 16 days)
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Safety as assessed by ARCI-49 (Part 1)
大体时间:Up to Day 2
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Addiction Research Center Inventory (ARCI)-49 (49-item)
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Up to Day 2
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Pharmacokinetic parameter of itraconazole (plasma): Ctrough (Part 2)
大体时间:Days 3-13
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Concentration immediately prior to dosing at multiple dosing
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Days 3-13
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUCinf (%extrap) (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Percentage of AUCinf due to extrapolation from tlast to time infinity (AUCinf [%extrap])
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): AUClast (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Cmax (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Maximum concentration (Cmax)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma):λz (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Terminal elimination rate constant (λz)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): MRT (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Mean residence time (MRT)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tlag (Part 2)
大体时间:Day 1 (period 1 and 2)
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Time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)
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Day 1 (period 1 and 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): tmax (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Time of maximum concentration (tmax)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): t1/2 (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Terminal elimination half-life (t1/2)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (plasma): Vz/F (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Apparent volume of distribution during the terminal elimination phase after extravascular dosing (Vz/F)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Cumulative amount of study drug excreted into urine from time of dosing up to the collection time of the last measurable concentration (Aelast)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Cumulative amount of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aelast% (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Percentage of study drug excreted into urine from the time of dosing up to the collection time of the last measurable concentration (Aelast%)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): Aeinf% (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
|
Percentage of study drug excreted into urine from time of dosing extrapolated to time infinity (Aeinf%)
|
Days 1-7 (period 1) and Days 1-13 (period 2)
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Pharmacokinetic parameter of ASP3700 with and without itraconazole (urine): CLR (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2)
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Renal clearance (CLR)
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Days 1-7 (period 1) and Days 1-13 (period 2)
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Safety as assessed by orthostatic evaluation (or blood pressure change in orthostatic challenge test) (Part 1)
大体时间:Up to Day 7
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Up to Day 7
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次要结果测量
结果测量 |
大体时间 |
---|---|
Composite of pharmacokinetics of ASP3700: AUCinf, AUCinf(%extrap), AUClast, Cmax, CL/F, λz, MRT, tlag, tmax, t½, Vz/F (plasma) (Part 1)
大体时间:up to Day 7
|
up to Day 7
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Title: Composite of pharmacokinetics of ASP3700: Aelast, Aeinf, Aelast%, Aeinf%, CLR (urine) (Part 1)
大体时间:up to Day 7
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up to Day 7
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Safety as assessed by adverse events, vital signs, orthostatic evaluation, laboratory tests, ECG measurements, C-SSRS, Bond & Lader VAS, ARCI-49 (Part 2)
大体时间:Days 1-7 (period 1) and Days 1-13 (period 2) and at end of study visit (up to 22 days)
|
Days 1-7 (period 1) and Days 1-13 (period 2) and at end of study visit (up to 22 days)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2014年10月1日
研究完成 (实际的)
2014年10月1日
研究注册日期
首次提交
2014年5月28日
首先提交符合 QC 标准的
2014年6月2日
首次发布 (估计)
2014年6月4日
研究记录更新
最后更新发布 (估计)
2014年10月30日
上次提交的符合 QC 标准的更新
2014年10月29日
最后验证
2014年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 3700-CL-0001
- 2013-005018-36 (EudraCT编号)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
安慰剂的临床试验
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的