A Single and Multiple Ascending and Food Effect Study of RP7214, a DHODH Inhibitor in Healthy Adult Subjects
2021年8月17日 更新者:Rhizen Pharmaceuticals SA
A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study and Food Effect Study of Oral RP7214, a DHODH Inhibitor, in Healthy Volunteers
This is a randomized, double-blind study to evaluate the safety, tolerability and PK of single and multiple ascending oral doses of RP7214.
The relative bioavailability in fed and fasting conditions will also be evaluated for RP7214.
The study comprises three parts; Part 1: Single ascending dose, Part 2: Multiple ascending dose and Part 3: Food effect.
研究概览
详细说明
There are three escalating cohorts in SAD part and two escalating cohorts in MAD part.
In each cohort, six eligible healthy volunteers will be randomized to receive either RP7214 or placebo in 2:1 ratio.
Within each cohort, two sentinel subjects (RP7214 and Placebo) will be dosed first for assessment of safety and tolerability.
The safety data of at least 48 hrs will be reviewed to confirm safety of sentinel subjects after which the remaining four subjects will be dosed.
Food effect study is a randomized, 2-treatment, 2-period, 2-sequence, crossover study in 12 HVs.
研究类型
介入性
注册 (实际的)
42
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
-
-
Nevada
-
Las Vegas、Nevada、美国、89121
- Rhizen Investigational Site
-
-
North Dakota
-
Fargo、North Dakota、美国、58104
- Rhizen Investigational Site
-
-
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:
- Subjects willing and able to provide informed consent for the trial
- Male and non-childbearing female subjects aged 18 to 55 years
- Healthy subjects as determined by pre-study medical history, vitals, physical examination and 12-lead ECG, and clinical laboratory tests within the normal reference ranges or clinically acceptable to investigator
- Non-tobacco user/non-smokers or ex-smokers defined as someone who has stopped smoking cigarettes for at least 6 months.
- Negative screen for drugs of abuse and alcohol at screening and on admission.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
- A male subject who is able to procreate should agree to use one of the accepted contraceptives and agree to refrain from donating sperm for at least 3 months after dosing; and should not father a child during this period.
- Female subjects should be of non-childbearing potential.
- Willing and able to understand the nature of this study, comply with the study procedures as required by the study protocol.
Exclusion Criteria:
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies) at the time of screening.
- Positive screen for hepatitis-B surface antigen (HBsAg), antibodies to the hepatitis C (HCV) or antibodies to the human immunodeficiency virus (HIV) 1 and 2.
- Subjects who received or are on Covid-19 directed prophylaxis (e.g. chloroquine or hydroxychloroquine) in last two weeks or 5x half-lives of the drug, whichever is shorter, prior to dosing.
- Subjects participating in another clinical study or use of any investigational product in last 30 days or 5x half-lives of the drug, whichever is shorter, prior to dosing.
- Pregnant or lactating females.
- Clinically significant abnormalities in physical examination and/or in laboratory tests (including hematology and chemistry panels, urinalysis) as assessed by the Investigator.
- Donation or loss of 400 mL or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulations/procedures.
- Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would in the opinion of investigator, pose an unacceptable risk to the subject in this study.
- Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
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:治疗
- 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:RP7214, Single and multiple doses
In Part 1 up to 3 cohorts with single ascending doses of RP7214 at 100 mg QD, 200 mg QD and 400 mg QD. In Part 2 up to 2 cohorts with multiple ascending doses of RP7214 at 200 mg BID, 400 mg BID. |
Participants will receive single and multiple ascending doses of RP7214
|
安慰剂比较:Placebo, Single and multiple doses
In Part 1 up to 3 cohorts and in Part 2 up to 2 cohorts with matching placebo to RP7214 tablet
|
Participants will receive single and multiple ascending doses of matching placebo
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Assessments of Adverse Events (AEs)
大体时间:Day1 - day15
|
Day1 - day15
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
RP7214 Cmax
大体时间:0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
Maximum Observed Plasma Concentration
|
0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
RP7214 Tmax
大体时间:0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
Time for maximum plasma concentration
|
0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
RP7214 t½
大体时间:0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
Terminal half-life
|
0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
RP7214 AUC0-inf
大体时间:0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
Area under the plasma concentration time curve from zero extrapolated to infinite time
|
0, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs post dose
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2020年12月29日
初级完成 (实际的)
2021年7月17日
研究完成 (实际的)
2021年7月19日
研究注册日期
首次提交
2020年12月17日
首先提交符合 QC 标准的
2020年12月17日
首次发布 (实际的)
2020年12月23日
研究记录更新
最后更新发布 (实际的)
2021年8月18日
上次提交的符合 QC 标准的更新
2021年8月17日
最后验证
2021年8月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- RP7214-2002
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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.
RP7214的临床试验
-
Rhizen Pharmaceuticals SA撤销急性髓性白血病 | 骨髓增生异常综合征 | 慢性粒单核细胞白血病
-
Rhizen Pharmaceuticals SAIncozen Therapeutics Pvt Ltd完全的