- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03590860
A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
2019년 2월 22일 업데이트: 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).
연구 개요
연구 유형
중재적
등록 (실제)
62
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Groningen, 네덜란드, 9728 NZ
- PRA Health Sciences
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
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Administered by SC injection
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위약 비교기: Placebo (Part A)
Placebo matching LY3322207 administered SC
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SC 주입으로 관리
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실험적: LY3322207 (Part B)
LY3322207 administered SC once weekly
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Administered by SC injection
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위약 비교기: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
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SC 주입으로 관리
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실험적: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
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Administered by SC injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants with One or More Serious Adverse Events (Part A)
기간: Baseline up to approximately 31 days
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Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 31 days
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Number of Participants with One or More Serious Adverse Events (Part B)
기간: Baseline up to approximately 9 weeks
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Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 9 weeks
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Number of Participants with One or More Serious Adverse Events (Part C)
기간: Baseline up to approximately 9 weeks
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Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 9 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
기간: Predose up approximately 31 days
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Pharmacokinetics (PK): AUC of LY3322207
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Predose up approximately 31 days
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Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
기간: 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)
기간: 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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Maximum Concentration (Cmax) of LY3322207 (Part A)
기간: Predose up approximately 31 days
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PK: Cmax of LY3322207
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Predose up approximately 31 days
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Maximum Concentration (Cmax) of LY3322207 (Part B)
기간: Predose up to approximately 9 weeks
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PK: Cmax of LY3322207
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Predose up to approximately 9 weeks
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Maximum Concentration (Cmax) of LY3322207 (Part C)
기간: Predose up to approximately 9 weeks
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PK: Cmax of LY3322207
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Predose up to approximately 9 weeks
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Time to reach Cmax (Tmax) of LY3322207 (Part A)
기간: 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)
기간: Predose up to approximately 9 weeks
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PK: Tmax of LY3322207
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Predose up to approximately 9 weeks
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Time to reach Cmax (Tmax) of LY3322207 (Part C)
기간: Predose up to approximately 9 weeks
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PK: Tmax of LY3322207
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Predose up to approximately 9 weeks
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Change from Baseline in Systolic Blood Pressure (SBP) (Part A)
기간: Baseline up approximately 31 days
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Supine position
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Baseline up approximately 31 days
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Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
기간: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
기간: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
기간: Baseline up approximately 31 days
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Supine position
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Baseline up approximately 31 days
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
기간: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
기간: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Heart Rate (Part A)
기간: Baseline up approximately 31 days
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Supine position
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Baseline up approximately 31 days
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Change from Baseline in Heart Rate (Part B)
기간: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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Change from Baseline in Heart Rate (Part C)
기간: Baseline up to approximately 9 weeks
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Supine position
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Baseline up to approximately 9 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 7월 13일
기본 완료 (실제)
2019년 1월 17일
연구 완료 (실제)
2019년 1월 17일
연구 등록 날짜
최초 제출
2018년 7월 6일
QC 기준을 충족하는 최초 제출
2018년 7월 6일
처음 게시됨 (실제)
2018년 7월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 2월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 2월 22일
마지막으로 확인됨
2019년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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