A Study of JNJ-70075200 in Healthy Participants
2021年12月14日 更新者：Janssen Research & Development, LLC
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-70075200 in Healthy Participants
The purpose of the study is to evaluate safety and tolerability of JNJ-70075200 compared with placebo after administration of single ascending doses of JNJ-70075200 as oral solution (Part 1); multiple ascending doses of JNJ-70075200, administered as oral solution over 14 consecutive days (Part 2); and the option of a single dose of JNJ-70075200 administered as an oral solid formulation (Part 3).
研究概览
研究类型
介入性
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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Groningen、荷兰、9728 NZ
- PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
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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:
- Participants be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening. Any abnormalities, must be considered not clinically significant
- Participants be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study
- No history of pathogen driven cancers (carcinomas, sarcomas, gastric cancer, bladder cancer,Cholangiocarcinoma)
- Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range 18 and 30 kilograms per square meter (kg/m^2) (BMI = weight/height^2) (inclusive)
- All women must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening
Exclusion criteria:
- Participants having a history of liver or renal insufficiency (estimated creatinine clearance [CL] below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Participants having a QT interval corrected according to Fridericia's formula (QTcF) greater than (>) 450 milliseconds (msec) for males, and >470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at Day -1
- Known allergies, hypersensitivity, or intolerance to JNJ-70075200 or its excipients
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participants having a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or Day -2
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：顺序分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Part 1: Single Ascending Dose (SAD)
Participants will receive an oral solution of JNJ-70075200 or placebo in single ascending doses on Day 1 in cohorts 1, 2, 3, 4, 5a and 6 under fasted condition.
Participants in cohort 5a will additionally receive the same study intervention under fed condition (Cohort 5b) after a washout period of at least 7 days.
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口服安慰剂溶液。
JNJ-70075200 solution or solid formulations will be administered orally.
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实验性的：Part 2: Multiple Ascending Dose (MAD)
After assessment of safety, tolerability and pharmacokinetics data in Part 1, participants will receive an oral solution of JNJ-70075200 or placebo twice daily in Cohorts 1 to 6 for 14 days under fasted/fed condition.
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口服安慰剂溶液。
JNJ-70075200 solution or solid formulations will be administered orally.
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实验性的：Part 3: Single-dose Oral Solid Formulation (Optional)
Participants will receive oral dose of JNJ-70075200 on Day 1 in Cohort 1 under fasted condition.
Part 3 will start after obtaining a formal regulatory/ethical approval.
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JNJ-70075200 solution or solid formulations will be administered orally.
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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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Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
大体时间：Up to 1 year and 1 month
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An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Up to 1 year and 1 month
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Percentage of Participants with Serious Adverse Events (SAEs)
大体时间：Up to 1 year and 1 month
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Up to 1 year and 1 month
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Number of Participants with Clinically Significant Changes in Vital Signs
大体时间：Up to 1 year and 1 month
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Number of participants with clinically significant changes in vital signs will be assessed.
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Up to 1 year and 1 month
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Number of Participants with Clinically Significant Changes in Physical Examination
大体时间：Up to 1 year and 1 month
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Number of participants with clinically significant changes in physical examination will be assessed.
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Up to 1 year and 1 month
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Number of Participants With Clinically Significant Laboratory Abnormalities
大体时间：Up to 1 year and 1 month
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Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
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Up to 1 year and 1 month
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Change From Baseline in QTc Interval
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiogram (ECG).
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Baseline, up to 1 year and 1 month
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Change from Baseline in Heart Rate (HR)
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in HR will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change from Baseline in QRS Interval
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in QRS interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change from Baseline in PR Interval
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in PR interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Change From Baseline in QT Interval
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in QT interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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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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Part 1, 2 and 3: Plasma Concentration of JNJ-70075200 Over Time
大体时间：Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)
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Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
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Part 1 and Part 3: Predose, up to 72 hours postdose (up to Day 4), Part 2: Predose, up to 24 hours postdose (up to Day 15)
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Part 1 and 3: Plasma Concentration of JNJ-70075200 Over Time (Food Effect)
大体时间：Predose, up to 72 hours postdose (up to Day 4)
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Plasma samples will be analyzed to determine concentrations of JNJ-70075200 using a validated, specific, and sensitive LC-MS/MS.
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Predose, up to 72 hours postdose (up to Day 4)
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Part 1 and 3: Percentage of Participants with TEAEs (Food Effect)
大体时间：Up to 1 year and 1 month
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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Up to 1 year and 1 month
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Part 1 and 3: Percentage of Participants with SAEs (Food Effect)
大体时间：Up to 1 year and 1 month
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A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants with Clinically Significant Changes in Vital Signs (Food Effect)
大体时间：Up to 1 year and 1 month
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Number of participants with clinically significant changes in vital signs will be assessed.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants with Clinically Significant Changes in Physical Examination (Food Effect)
大体时间：Up to 1 year and 1 month
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Number of participants with clinically significant changes in physical examination will be assessed.
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Up to 1 year and 1 month
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Part 1 and 3: Number of Participants With Clinically Significant Laboratory Abnormalities (Food Effect)
大体时间：Up to 1 year and 1 month
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Number of participants with clinically significant laboratory abnormalities related to hematology and clinical chemistry will be reported.
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Up to 1 year and 1 month
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Part 1 and 3: Change From Baseline in QTc Interval (Food Effect)
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in QTc interval using Fridericia method will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in HR (Food Effect)
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in HR will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in QRS Interval (Food Effect)
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in QRS interval will be measured by ECG.
|
Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change from Baseline in PR Interval (Food Effect)
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in PR interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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Part 1 and Part 3: Change From Baseline in QT Interval (Food Effect)
大体时间：Baseline, up to 1 year and 1 month
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Change from baseline in QT interval will be measured by ECG.
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Baseline, up to 1 year and 1 month
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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。
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 (预期的)
2022年3月1日
初级完成 (预期的)
2022年5月9日
研究完成 (预期的)
2022年9月23日
研究注册日期
首次提交
2021年2月16日
首先提交符合 QC 标准的
2021年3月3日
首次发布 (实际的)
2021年3月4日
研究记录更新
最后更新发布 (实际的)
2022年1月5日
上次提交的符合 QC 标准的更新
2021年12月14日
最后验证
2021年12月1日
更多信息
与本研究相关的术语
其他研究编号
- CR108971
- 2020-004946-12 (EudraCT编号)
- 70075200SLE1001 (其他标识符：Janssen Research & Development, LLC)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
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.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的