NCT05952089已完成1 期
An Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of Danicamtiv on the Pharmacokinetics of Midazolam in Patients With Stable Heart Failure With Reduced Ejection Fraction
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年8月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is assess the effect of danicamtiv, as an inducer on the drug levels of midazolam in participants with heart failure with reduced ejection fraction (HFrEF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory participants with stable HFrEF due to any etiology.
- •Body mass index (BMI) of 18.0 kilogram per square meter (kg/m2) to 35.0 kg/m2 inclusive.
- •Documented left ventricular ejection fraction (LVEF) 15% to 45% (on 2 occasions), including at least once during Screening and confirmed by the Echo Core Laboratory (the absolute difference between the 2 LVEF values qualifying the participant should be < 12%).
- •Participant receiving chronic medication for the treatment of heart failure reflecting current guidelines, including at least one of the following, unless not tolerated or contraindicated:β-blocker, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, or angiotensin receptor neprilysin inhibitor. Such treatments should have been given at stable doses for at least ≥ 2 weeks prior to screening with no plan to modify treatments during the study.
- •Sinus rhythm or stable atrial or ventricular pacing or persistent atrial fibrillation that is adequately rate-controlled to allow pharmacodynamic (PD) assessments by Transthoracic echocardiogram (TTE). NOTE: Participants with implanted cardioverter defibrillator (ICD), pacing, or cardiac resynchronization therapy are eligible provided device programming is unchanged starting 2 months prior to and throughout the dosing period.
- •Adequate acoustic windows, determined by the Echo Core Laboratory, to enable accurate TTE assessments.
排除标准
- •Presence of disqualifying cardiac rhythms that would preclude echocardiographic assessments, as determined by the Investigator, including: (a) rapid, inadequately rate controlled atrial fibrillation or (b) frequent premature ventricular contractions that might interfere with reliable echocardiographic measurements of left ventricular function.
- •History of bronchospasm, or history of respiratory depression or arrest, airway obstruction, oxygen desaturation, or apnea.
- •History of allergy to midazolam, other benzodiazepines, danicamtiv, related compounds, or excipients in the formulations.
- •Severe renal insufficiency (defined as current estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 by simplified Modification of Diet in Renal Disease equation [sMDRD].
研究组 & 干预措施
Danicamtiv + Midazolam
Experimental
干预措施: Danicamtiv (Drug)
Danicamtiv + Midazolam
Experimental
干预措施: Midazolam (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 12
Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC[INF])
时间窗: Up to Day 12
Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
时间窗: Up to Day 12
次要结局
- Time of maximum observed plasma concentration (Tmax)(Up to Day 12)
- Terminal elimination half-life (T-HALF)(Up to Day 12)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to Day 12)
- Number of participants with vital sign abnormalities(Up to Day 12)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 12)
- Number of participants with physical examination abnormalities(Up to Day 12)
- Number of participants with clinical laboratory abnormalities(Up to Day 11)
研究者
研究点 (5)
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