A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
2019年2月22日 更新者:Eli Lilly and Company
A Safety, Tolerability, and Pharmacokinetic Study of Single and Multiple Ascending Doses of LY3322207 in Healthy Subjects and Subjects With Hypertension on ACE I/ARB Therapy
The purpose of this study is to investigate the safety of the study drug known as LY3322207.
Participants must be healthy or must have hypertension (high blood pressure).
Participants with hypertension may already be taking a common drug to reduce blood pressure called an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
研究概览
研究类型
介入性
注册 (实际的)
62
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
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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 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy males, as determined by medical history and physical examination, must agree to use a medically appropriate method of birth control and agree not to donate sperm from start of dosing until 90 days beyond last dose
Healthy females, as determined by medical history and physical examination, of non-child bearing potential due to:
- Menopause: spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (for example: oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
- Surgical sterilization
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
- Have a Body Mass Index (BMI) 18 to 30 kilogram per square meter (kg/m²) at entry
- Have clinical laboratory test results within normal reference range for the population or site, or results with acceptable deviations that are judged not clinically significant
- Be 18 to 55 years old for either Part A or Part B of the study, or 18 to 65 years old for Part C only
- For Part C: must have been treated with a stable dose of ACE-I or ARB for at least 1 month
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval
- Have previously completed or withdrawn from this study or any other study investigating this study drug
- Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, significant atopy, or any clinically significant laboratory abnormality that would preclude study participation
- Have abnormality in the 12-lead electrocardiogram (ECG) which increases study risk
- Have confirmed QT interval corrected by Bazett's method (QTcB) or Fridericia's (QTcF) method >450 millisecond (msec) for men and >470 msec for women
- Have prior Q-wave myocardial infarction or other, specific heart abnormalities, arrhythmias or fibrillations
- Have an abnormal blood pressure (supine) defined as diastolic blood pressure greater than (>)95 or less than (<)50 millimeters of mercury (mmHg) and/or systolic blood pressure >160 or <90 mmHg
- Show evidence of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
- Have donated blood of more than 100 mL (milliliters) within the last month
- Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit
- Have an average weekly alcohol intake that exceeds 21 units per week (1 unit equal to (=) 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- Have an abnormal blood pressure (supine) defined as diastolic blood pressure >95 or <50 mmHg and/or systolic blood pressure >160 or <90 mmHg
- Have serum potassium outside normal range
- Have had lymphoma, leukemia, or any malignancy within the past 5 years
- Have clinically significant multiple or severe drug allergies or intolerance
- Are lactating women
- Positive findings for known drugs of abuse
- Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
- Participation in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be compatible with this study
- Have estimated glomerular filtration rate (eGFR) < 60 milliliters per minute per 1.73 square meter (mL/min/1.73 m²) for Parts A and B of this study, or eGFR < 50 mL/min/1.73 m² in Part C only
- For Part C: have a history of severe hypertension (defined as SBP greater than or equal to (≥)180 mmHg and/or DBP ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension
- For Part C: have a history of supraventricular tachycardia (for example, atrial fibrillation), ventricular tachycardia, or other cardiac arrhythmia
- For Part C: have resting tachycardia (heart rate ≥100 beats per minute)
- For Part C: have New York Heart Association (NYHA) Class II, III, or IV heart failure, or had any of the following in the previous 3 months: coronary angioplasty, coronary stent placement, coronary bypass surgery or any significant cardiac surgery, myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack
- For Part C: have an automatic internal cardioverter-defibrillator
- For Part C: have diabetes
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:LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
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Administered by SC injection
|
|
安慰剂比较:Placebo (Part A)
Placebo matching LY3322207 administered SC
|
SC注射给药
|
|
实验性的:LY3322207 (Part B)
LY3322207 administered SC once weekly
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Administered by SC injection
|
|
安慰剂比较:Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
|
SC注射给药
|
|
实验性的:LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
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Administered by SC injection
|
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 |
|---|---|---|
|
Number of Participants with One or More Serious Adverse Events (Part A)
大体时间:Baseline up to approximately 31 days
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 31 days
|
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Number of Participants with One or More Serious Adverse Events (Part B)
大体时间:Baseline up to approximately 9 weeks
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 9 weeks
|
|
Number of Participants with One or More Serious Adverse Events (Part C)
大体时间:Baseline up to approximately 9 weeks
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 9 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
大体时间:Predose up approximately 31 days
|
Pharmacokinetics (PK): AUC of LY3322207
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Predose up approximately 31 days
|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
大体时间:Predose up to approximately 9 weeks
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PK: AUC of LY3322207
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Predose up to approximately 9 weeks
|
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Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)
大体时间:Predose up to approximately 9 weeks
|
PK: AUC of LY3322207
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Predose up to approximately 9 weeks
|
|
Maximum Concentration (Cmax) of LY3322207 (Part A)
大体时间:Predose up approximately 31 days
|
PK: Cmax of LY3322207
|
Predose up approximately 31 days
|
|
Maximum Concentration (Cmax) of LY3322207 (Part B)
大体时间:Predose up to approximately 9 weeks
|
PK: Cmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Maximum Concentration (Cmax) of LY3322207 (Part C)
大体时间:Predose up to approximately 9 weeks
|
PK: Cmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Time to reach Cmax (Tmax) of LY3322207 (Part A)
大体时间:Predose up to approximately Day 31
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PK: Tmax of LY3322207
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Predose up to approximately Day 31
|
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Time to reach Cmax (Tmax) of LY3322207 (Part B)
大体时间:Predose up to approximately 9 weeks
|
PK: Tmax of LY3322207
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Predose up to approximately 9 weeks
|
|
Time to reach Cmax (Tmax) of LY3322207 (Part C)
大体时间:Predose up to approximately 9 weeks
|
PK: Tmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part A)
大体时间:Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
大体时间:Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
大体时间:Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
大体时间:Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
大体时间:Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
大体时间:Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Heart Rate (Part A)
大体时间:Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Heart Rate (Part B)
大体时间:Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Heart Rate (Part C)
大体时间:Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
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 (实际的)
2018年7月13日
初级完成 (实际的)
2019年1月17日
研究完成 (实际的)
2019年1月17日
研究注册日期
首次提交
2018年7月6日
首先提交符合 QC 标准的
2018年7月6日
首次发布 (实际的)
2018年7月18日
研究记录更新
最后更新发布 (实际的)
2019年2月25日
上次提交的符合 QC 标准的更新
2019年2月22日
最后验证
2019年2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.