NCT03590860终止1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Serious Adverse Events (Part A)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Part C will be open label
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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- •Have previously completed or withdrawn from this study or any other study investigating this study drug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
研究组 & 干预措施
LY3322207 (Part A)
Experimental
LY3322207 administered subcutaneously (SC)
干预措施: LY3322207 (Drug)
Placebo (Part A)
Placebo Comparator
Placebo matching LY3322207 administered SC
干预措施: Placebo (Drug)
LY3322207 (Part B)
Experimental
LY3322207 administered SC once weekly
干预措施: LY3322207 (Drug)
Placebo (Part B)
Placebo Comparator
Placebo matching LY3322207 administered SC once weekly
干预措施: Placebo (Drug)
LY3322207 (Part C)
Experimental
LY3322207 administered SC in participants with hypertension
干预措施: LY3322207 (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Events (Part A)
时间窗: Baseline up to approximately 31 days
Serious and other non-serious adverse events will be reported in the Adverse Events Module
Number of Participants with One or More Serious Adverse Events (Part C)
时间窗: Baseline up to approximately 9 weeks
Serious and other non-serious adverse events will be reported in the Adverse Events Module
Number of Participants with One or More Serious Adverse Events (Part B)
时间窗: Baseline up to approximately 9 weeks
Serious and other non-serious adverse events will be reported in the Adverse Events Module
次要结局
- Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)(Predose up to approximately 9 weeks)
- Maximum Concentration (Cmax) of LY3322207 (Part A)(Predose up approximately 31 days)
- Time to reach Cmax (Tmax) of LY3322207 (Part B)(Predose up to approximately 9 weeks)
- Time to reach Cmax (Tmax) of LY3322207 (Part C)(Predose up to approximately 9 weeks)
- Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)(Baseline up approximately 31 days)
- Maximum Concentration (Cmax) of LY3322207 (Part B)(Predose up to approximately 9 weeks)
- Change from Baseline in Systolic Blood Pressure (SBP) (Part B)(Baseline up to approximately 9 weeks)
- Time to reach Cmax (Tmax) of LY3322207 (Part A)(Predose up to approximately Day 31)
- Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)(Predose up approximately 31 days)
- Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)(Predose up to approximately 9 weeks)
- Change from Baseline in Systolic Blood Pressure (SBP) (Part A)(Baseline up approximately 31 days)
- Change from Baseline in Systolic Blood Pressure (SBP) (Part C)(Baseline up to approximately 9 weeks)
- Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)(Baseline up to approximately 9 weeks)
- Change from Baseline in Heart Rate (Part B)(Baseline up to approximately 9 weeks)
- Change from Baseline in Heart Rate (Part A)(Baseline up approximately 31 days)
- Change from Baseline in Heart Rate (Part C)(Baseline up to approximately 9 weeks)
- Maximum Concentration (Cmax) of LY3322207 (Part C)(Predose up to approximately 9 weeks)
- Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)(Baseline up to approximately 9 weeks)
研究者
研究点 (1)
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