Phase 1 Safety and PK Study of OLT1177 Capsules
2015年3月5日 更新者:Olatec Therapeutics LLC
A Phase 1, Randomized, Dose Escalation, Single Center, Safety and Pharmacokinetic Study of Single and Multi-Dose, Orally Administered OLT1177 Capsules in Healthy Subjects
This study is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers after administration of single or multiple dose(s) of investigational drug (OLT1177 Caps or Placebo Caps).
A total of 36 subjects will be enrolled across 6 cohorts, and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo.
研究概览
研究类型
介入性
注册 (实际的)
35
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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Texas
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College Station、Texas、美国、77845
- J&S Studies, Inc
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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 60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:
- Age 18 to 60 years old, inclusive
- In good health as determined by the Investigator based on subject's medical history, ECG and physical examination at Baseline and safety laboratory tests (chemistry, hematology, coagulation and urinalysis) at Screening
- Normal blood pressure of 130/85 mmHg or lower
- Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to comply with all the requirements of the study
Exclusion Criteria:
Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential who:
- Are or intend to become pregnant (including use of fertility drugs) during the study
- Are nursing
- Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the study.)
- Use of any drug treatment at the time of the study (with the exception of 81 mg aspirin and prescription oral or systemic contraceptives)
- Taking any prescription medications (other than oral or systemic contraceptives) within 14 days prior to administration of investigational drug or taking any over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 14 days prior to administration of investigational drug, except for topical products without systemic absorption
- Use of NSAIDs or other prescription pain medication, more than once or twice a week, especially if taken for chronic or frequently recurring headache
- Active infection within 3 days of the Baseline visit
- History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
- Diagnosed with any form of internal cancer within the past 5 years
- Any other medical conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing any protocol requirements
- History of anaphylactic reactions to any systemic or topical compounds
- Have donated plasma (500 mL) within 7 days prior to drug administration
- Have donated or lost whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows: 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration
- Is a user of any nicotine products (including chewing tobacco, snuff and/or e-cigarettes)
- Is not willing to restrict food or beverage including: alcohol, caffeine, poppy seeds, xanthine derivatives or xanthine-related compounds, energy drinks, natural health products, grapefruit juice, pomelo, Seville orange and marmalade use during the study as specified in Section 7.1.5
- Is lactose intolerant
- Is unable or unwilling to consume products containing bovine byproducts
- Is unable to adhere to or understand the requirements of the protocol
- If continuing on to Part B, subject is unable or unwilling to ingest the full study-provided high-fat breakfast within 30 minutes
- Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit
- Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01, Study OLT1177-02 or Study OLT1177-03
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:单组作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:OLT1177 Capsules
A total of 5 patients in each cohort will receive OLT1177 Capsules:
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OLT1177 Capsules are an experimental drug.
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安慰剂比较:Placebo Capsules
A total of 1 patient in each cohort will receive Placebo Capsules:
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Placebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient.
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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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Recording of adverse events
大体时间:Screening through Day 28 follow-up
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Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.
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Screening through Day 28 follow-up
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety Laboratory Measurements
大体时间:Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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Blood samples will be drawn and analyzed for: chemistry, hematology, lipids and coagulation.
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Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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Electrocardiogram
大体时间:Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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Electrocardiograms will be captured and analyzed for changes throughout the duration of the study.
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Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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Vital Signs
大体时间:Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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Vital signs (pulse, resting blood pressure, temperature and respirations) will be recorded and analyzed for changes throughout the duration of the study.
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Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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Physical Examination
大体时间:Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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Physical examinations will be conducted to assess changes in subject health throughout the duration of the study.
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Screening through Day 15 (Part A&B)/Day 22 (Part C) visit
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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:Terry M Jones, MD, FAAD、J&S Studies
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6月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2014年5月7日
首先提交符合 QC 标准的
2014年5月7日
首次发布 (估计)
2014年5月9日
研究记录更新
最后更新发布 (估计)
2015年3月6日
上次提交的符合 QC 标准的更新
2015年3月5日
最后验证
2015年3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.
OLT1177 Capsules的临床试验
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Olatec Therapeutics LLCRadboud University Medical Center终止
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Olatec Therapeutics LLC招聘中
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Olatec Therapeutics LLCCTI Clinical Trial and Consulting Services终止
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University Hospital, Basel, SwitzerlandOlatec Therapeutics LLC; State Secretariat for Education Research and Innovation, Switzerland; European Union (Horizon Europe Programme)尚未招聘