A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers
2018年5月29日 更新者：Biota Scientific Management Pty Ltd
A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Vapendavir (BTA798) on the Pharmacokinetics of Orally Administered Midazolam, a CYP3A4 Substrate, in Healthy Male and Female Volunteers
The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate.
Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.
研究概览
研究类型
介入性
注册 (实际的)
24
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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Minnesota
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Saint Paul、Minnesota、美国、55114
- Prism Clinical Research
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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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening;
- Capable of giving written informed consent;
- Subject is able to understand and comply with the protocol requirements, instructions and restrictions;
- Healthy on the basis of physical examination, medical history, medication usage, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;
- Female subjects who are not post-menopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as a condom plus spermicidal agent (foam/gel/film/cream/suppository); and
- Female subjects must not be breastfeeding or pregnant.
Exclusion Criteria:
- Positive results for Hepatitis B, Hepatitis C, or HIV;
- Frequent use (defined as > 5 times/day) of tobacco products, including cigarettes, cigars, chewing tobacco;
- A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event;
- Current or recent respiratory infection (defined as within 14 days of first study visit participation)
- Presence or history of significant allergy;
- Clinically significant abnormalities noted on ECG;
- Screening vital signs representing sustained elevated systolic blood pressure <90 mmHg or >140 mmHg, and/or diastolic blood pressure <55 mmHg or >90 mmHg.
- Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;
- Safety laboratory abnormalities noted at screening which are clinically significant
- Current or defined history of abuse of alcohol or illicit drugs;
- A positive pregnancy test at screening;
- Poor vein access or fear of venipuncture or sight of blood; and
- Regular consumption of alcohol defined as either > 2 units (glass or shot) of alcoholic beverages per day or > 14 units per week.
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：其他
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Vapendavir 528 mg QD
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
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All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.
Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
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实验性的：Vapendavir 264 mg BID
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.
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All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.
Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.
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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 |
|---|---|---|
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The Effect of Vapendavir on the PK Profile of Midazolam
大体时间：End of Study (up to 46 weeks in duration)
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To evaluate the effect of vapendavir daily dose of 264 mg BID on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:
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End of Study (up to 46 weeks in duration)
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The Effect of Vapendavir on the PK Profile of Midazolam
大体时间：End of Study (up to 46 weeks in duration)
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To evaluate the effect of vapendavir daily dose of 528 mg QD on the PK profile of midazolam, a CYP3A4 substrate. The primary outcome will be evaluated through a series of analyses of PK parameters including:
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End of Study (up to 46 weeks in duration)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assess Whether PK Profile of Vapendavir is Affected by Presence of Midazolam
大体时间：End of Study (up to 46 weeks in duration)
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To evaluate whether the PK profile of vapendavir, is affected by the presence of midazolam, a strong CYP3A4 substrate. This outcome will be evaluated through a series of analyses of PK parameters for vapendavir including:
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End of Study (up to 46 weeks in duration)
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Assess the Safety of Vapendavir
大体时间：End of Study (up to 46 weeks in duration
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To evaluate the safety of vapendavir.
This will be accomplished by assessing adverse events, clinical laboratory tests (including blood chemistry, hematology with differential and urinalysis), physical exams, ECG assessments, vital sign assessments and concomitant medications.
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End of Study (up to 46 weeks in duration
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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。
调查人员
- 首席研究员：Mark Matson, MD、Prism Clinical Research
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6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2014年5月27日
首先提交符合 QC 标准的
2014年7月29日
首次发布 (估计)
2014年7月30日
研究记录更新
最后更新发布 (实际的)
2018年5月30日
上次提交的符合 QC 标准的更新
2018年5月29日
最后验证
2018年5月1日
更多信息
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.