A Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986308 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986308 compared to placebo in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be in good health, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •Must have a body mass index (BMI) of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, at screening. BMI = weight (kg)/height (m)^2
- •Must have normal renal function at screening (and study admission) as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula
排除标准
- •Any significant acute or chronic medical illness
- •Presence or need for urinary catheterization, urinary tract abnormality, or disorder interfering with urination
- •History of tinnitus or hearing impairment, including deafness
- •History or risks factors for Torsade de Pointes and Long QT syndrome (such as electrolyte imbalances, etc)
- •History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- •Consumption of caffeine or xanthine-containing food or beverages within 72 hours prior to study treatment administration
- •Use of any prescription drugs or over-the-counter (OTC) acid controllers within 4 weeks prior to study treatment administration except those medications cleared by the Medical Monitor
- •Use of any other drugs, including OTC medications within 1 week and herbal preparations, within 2 weeks prior to study treatment administration except those medications cleared by the Medical Monitor
- •Use of diuretics (loop diuretics, thiazide diuretics, potassium-sparing diuretics [spironolactone, amiloride]), oral calcium, potassium or magnesium supplements (including multi-vitamins) or use of non-steroidal anti-inflammatory drugs within 72 hours of the first study treatment
- •Use of concomitant medications that are strong inhibitors or inducers of cytochrome CYP3A4 or OATP administered within 2 weeks prior to study treatment administration and throughout the study
- •Consumption of any nutrients known to modulate cytochrome P450 (CYP) enzymes activity (eg, grapefruit, or grapefruit juice,pomelo juice, star fruit, or Seville [blood] orange products) within 14 days prior to first administration of study treatment
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population of healthy volunteers
- •History of allergy to furosemide, sulfonamides, other loop diuretics (furosemide cohort only), BMS-986308 or related compounds, components of the suspension or solution, including hydroxypropylmethylcellulose
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A Furosemide
干预措施: Furosemide (Drug)
Part B (SAD)
Single Ascending Dose (SAD)
干预措施: BMS-986308 (Drug)
Part B (SAD)
Single Ascending Dose (SAD)
干预措施: Placebo (for BMS-986308) (Other)
结局指标
主要结局
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in vital signs: Respiratory rate
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in vital signs: Supine blood pressure
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in vital signs: Orthostatic hypotension measurements performed as per clinical research unit's standard operating procedure
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
时间窗: Up to 19 days
Part B PR interval is the time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
时间窗: Up to 19 days
Part B QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
时间窗: Up to 19 days
Part B The QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
时间窗: Up to 19 days
Part B QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Incidence of clinically significant changes in cardiac telemetry
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in physical examination findings
时间窗: Up to 19 days
Part B
Incidence of Adverse Events (AEs)
时间窗: Up to 19 days
Part B
Incidence of serious adverse events (SAEs)
时间窗: Up to 19 days
Part B
Incidence of death
时间窗: Up to 19 days
Part B
Incidence of adverse events (AEs) leading to discontinuation
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in vital signs: Heart rate
时间窗: Up to 19 days
Part B
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
时间窗: Up to 19 days
Part B
次要结局
未报告次要终点