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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).

調査の概要

状態

終了しました

条件

研究の種類

介入

入学 (実際)

62

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Groningen、オランダ、9728 NZ
        • PRA Health Sciences

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~65年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
Administered by SC injection
プラセボコンパレーター:Placebo (Part A)
Placebo matching LY3322207 administered SC
皮下注射による投与
実験的:LY3322207 (Part B)
LY3322207 administered SC once weekly
Administered by SC injection
プラセボコンパレーター:Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
皮下注射による投与
実験的:LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
Administered by SC injection

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants with One or More Serious Adverse Events (Part A)
時間枠: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
Number of Participants with One or More Serious Adverse Events (Part B)
時間枠: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)
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
時間枠:Predose up approximately 31 days
Pharmacokinetics (PK): AUC of LY3322207
Predose up approximately 31 days
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
時間枠:Predose up to approximately 9 weeks
PK: AUC of LY3322207
Predose up to approximately 9 weeks
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)
時間枠:Predose up to approximately 9 weeks
PK: AUC of LY3322207
Predose up to approximately 9 weeks
Maximum Concentration (Cmax) of LY3322207 (Part A)
時間枠:Predose up approximately 31 days
PK: Cmax of LY3322207
Predose up approximately 31 days
Maximum Concentration (Cmax) of LY3322207 (Part B)
時間枠:Predose up to approximately 9 weeks
PK: Cmax of LY3322207
Predose up to approximately 9 weeks
Maximum Concentration (Cmax) of LY3322207 (Part C)
時間枠: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)
時間枠:Predose up to approximately Day 31
PK: Tmax of LY3322207
Predose up to approximately Day 31
Time to reach Cmax (Tmax) of LY3322207 (Part B)
時間枠:Predose up to approximately 9 weeks
PK: Tmax of LY3322207
Predose up to approximately 9 weeks
Time to reach Cmax (Tmax) of LY3322207 (Part C)
時間枠: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)
時間枠:Baseline up approximately 31 days
Supine position
Baseline up approximately 31 days
Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
時間枠:Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
時間枠:Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
時間枠:Baseline up approximately 31 days
Supine position
Baseline up approximately 31 days
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
時間枠:Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
時間枠:Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Heart Rate (Part A)
時間枠:Baseline up approximately 31 days
Supine position
Baseline up approximately 31 days
Change from Baseline in Heart Rate (Part B)
時間枠:Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks
Change from Baseline in Heart Rate (Part C)
時間枠:Baseline up to approximately 9 weeks
Supine position
Baseline up to approximately 9 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年7月13日

一次修了 (実際)

2019年1月17日

研究の完了 (実際)

2019年1月17日

試験登録日

最初に提出

2018年7月6日

QC基準を満たした最初の提出物

2018年7月6日

最初の投稿 (実際)

2018年7月18日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月25日

QC基準を満たした最後の更新が送信されました

2019年2月22日

最終確認日

2019年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 16771
  • I9K-MC-UCAA (その他の識別子:Eli Lilly and Company)
  • 2018-002337-38 (EudraCT番号)

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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