NL-OMON48858已完成不适用
A randomized, double-blinded, placebo-Controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BMS-986224 in healthy subjects and chronic heart failure patients with reduced ejection fraction - BMS-986224 SAD MAD study
Britsol-Myers Squibb International Corporation0 个研究点目标入组 165 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Part A and B
- •- Males and females, ages 18 to 55 years, inclusive, female subjects should be of non childbearing potential, at screening.
- •- BMI of 18.0 to 30.0 kg/m2, inclusive, at Screening. BMI = weight (kg)/height m2.;Part C
- •1. Signed written informed consent.
- •2. Subjects must be willing to participate in the study and sign the ICF.
- •3. Subjects must be willing and able to complete all study-specific procedures and visits.
- •4. Males and females, ages 18 years or older, at screening; female subjects should be of non childbearing potential (see Inclusion Criterion 12).
- •5. BMI of 18.0 to 35.0 kg/m2, inclusive, at screening. BMI = weight (kg)/height m2.
- •6. New York Heart Association class II or III.
- •7. Left ventricular EF <45%, as assessed by cardiac MRI within 3 months of first dose of study drug; or left ventricular EF <40% as assessed by echocardiogram, multiple gated acquisition (MUGA) or single photon emission computed tomography (SPECT) at screening or within 3 months of first dose of study drug
- •8. Have not had a myocardial infarction within 3 months of first dose of study drug, or have not had any other acute cardiovascular (CV) event or hospitalization (including emergency room visits) for CV causes within 1 month of first dose of study drug and are considered to have stable heart failure at the discretion of the Investigator (also refer to Exclusion Criteria #21 for Part C).
- •9. Stable guideline directed therapy for HF (could include oral diuretics, ACEi, ARBs, ARNi, MRAs, and β-blockers as tolerated), and stable medications for other chronic comorbidities (as cleared by the PI and PRA Medical Monitor), with no dose changes of these medications in the past 1 month prior to start of study drug. The use of pre-determined patient-managed flexible oral loop diuretics is permitted.
- •10. Have screening values of NT pro-BNP >= 300 pg/mL (35 pmol/L) or BNP >= 100 pg/mL (29 pmol/L).
- •11. Regular sinus rhythm at screening and no history of atrial fibrillation in the past 12 months.
- •12. Postmenopausal women (12 months or more amenorrhea and over 45 years of age in the absence of other biological or physiological causes). Females under 55 years of age require FSH >40 mIU/mL at screening.
- •13. Women must not be breastfeeding.
- •14. Males that meet one of the following:
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of the study and a minimum of 3 months after dosing has been completed. In addition, male subjects must be willing to refrain from sperm donation during this time.
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS.
- •In case of participation in another drug study within 90 days before the start of this study. Being a blood donor (Part A & B)/Loss of more than 100 mL blood (Part C) within 60 days prior to the first study drug administration. In case of donating more than 1.5 liters of blood (male subjects)/1 liter (female subjects) in the 10 months prior the first study drug administration.
- •We refer to section 9.3.2 if the protocol for a complete overview of all the exclusion criteria.;Part C:
- •1. Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption. Patients who suffer from an episode of acute gastroenteritis without an underlying chronic GI condition can be enrolled if the acute event occurred more than 1 month prior to the first dose of study drug.
- •2. Major surgery within 4 weeks of (first) study treatment administration.
- •3. Loss of more than 100 mL of blood within 2 months prior to the first drug administration. Loss of more than 1.5 L of blood (for male subjects) / more than 1.0 L of blood (for female subjects) in the 10 months prior to the first drug administration in the current study.
- •4. Inability to be venipunctured and/or tolerate venous access.
- •5. Not applicable per Protocol Amendment 4: Subjects who have smoked or used smoking cessation or nicotine containing products (including, but not limited to, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum, varenicline, bupropion) within 3 months of the first dose of study drug.
- •6. Abuse or drug addiction (including cannabis products) within one year from screening.
- •7. Positive drug screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids or barbiturates) at screening or admission to the CRU. Any positive drug screen test will be discussed with the Medical Monitor for further assessment. If justified in the opinion of the PI and Medical Monitor, the patient can be eligible for the study, despite a positive urinary drug screen.
- •8. Average intake of more than 21 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits).
- •9. Participation in a drug study or exposure to investigational drug or placebo within 2 months prior to the first drug administration in the current study.
- •10. Any contraindication to MRI scanning (eg, claustrophobia, implantable devices, etc).
- •11. Systolic blood pressure >180 mmHg or <100 mmHg.
- •12. Heart rate <50 beats per minute (bpm) or >90 bpm at screening or pre-randomization. A patient is eligible if clinically stable as per PI*s assessment and if heart rate at rest is at least 50 bpm, up to a maximum of 90 bpm, on vital signs taken at both the screening visit and the Day -1 visit (or pre dose Day 1 if patient admits to the clinic on Day 1 instead of Day -1), regardless of the heart rate reported on ECG.
- •13. Atrial arrhythmia (fibrillation, flutter) at screening or pre-randomization.
- •14. Significant ventricular arrhythmia (eg more than one couplet, triplets, or any VT-runs of 6 consecutive beats or more) on baseline or screening ECG. Note that a history of (ie, anterior to screening) couplets, triplets or non-sustained VT (<6 consecutive beats) does not exclude a patient from participation.
- •15. Presence of pacemakers/implantable cardioverter-de
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