NCT05924321已完成1 期
A Randomized, 2-Part, Crossover Trial to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline of HR (∆HR).
研究概览
简要总结
Carbetocin is an oxytocin receptor agonist that selectively binds to receptors in the smooth muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterine musculature. Carbetocin is approved in >100 countries for the prevention of postpartum hemorrhage due to uterine atony in women following cesarean or vaginal delivery. Per regulatory requirements, the current trial will evaluate the effects of high clinical exposure of carbetocin on the QT interval corrected for heart rate (QTc) as measured by ECG in healthy men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial will consist of two parts; Part A and Part B. Part A is an open-label single group trial while Part B is a double-blind trial with 3 groups.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male or female subjects, 18-45 years of age, inclusive, at the screening visit.
- •Body mass index (BMI) ≥ 18.5 and ≤29.9 kg/m2 at the screening visit.
- •Continuous non-smoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to first dosing.
排除标准
- •Sustained supine systolic blood pressure ≥130 mmHg or <90 mmHg, supine diastolic blood pressure ≥80 mmHg or <50 mmHg at screening or first check-in.
- •History or presence of clinically significant ECG findings in the opinion of the Principal Investigator (PI) or designee at the screening visit or first check-in, including each of the following:
- •HR <45 bpm or >100 bpm.
- •QTcF is ≥450 msec (males) or ≥460 msec (females).
- •QRS ≥110 msec; if ≥110 msec, result will be confirmed by a manual over read.
- •PR ≥200 msec.
- •History or presence of:
- •Risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT syndrome, Brugada syndrome, or sudden cardiac death).
- •Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial infarction, angina, pulmonary congestion, symptomatic or significant cardiac arrhythmia, or clinically significant conduction abnormalities.
- •Clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia, in the opinion of the PI or designee.
研究组 & 干预措施
Carbetocin
Experimental
Single IV infusion of carbetocin
干预措施: Carbetocin (Drug)
Placebo
Placebo Comparator
Single IV Infusion of matching placebo
干预措施: Placebo (Drug)
Placebo and Moxifloxacin
Active Comparator
Single IV infusion of matching placebo with a single oral dose of moxifloxacin
干预措施: Placebo and Moxifloxacin (Drug)
结局指标
主要结局
Change from baseline of HR (∆HR).
时间窗: Up to 240 minutes after Start of Infusion
Part A
Observed Heart rate(HR) values
时间窗: Up to 240 minutes after Start of Infusion
Part A
Placebo-corrected change from baseline in QT interval (∆∆QTc) using the most appropriate HR correction method (i.e., ∆∆QTcF if Fridericia's method is used).
时间窗: Up to 24 hours after Start of Infusion
Part B
次要结局
- Carbetocin PK parameters: AUC%extrap(Up to 24 hours after Start of Infusion)
- Carbetocin PK parameters: Cmax(Up to 24 hours after Start of Infusion)
- Carbetocin PK parameters: Tmax(Up to 24 hours after Start of Infusion)
- Carbetocin PK parameters: t½(Up to 24 hours after Start of Infusion)
- Carbetocin PK parameters: MRTinf(Up to 24 hours after Start of Infusion)
- Carbetocin PK parameters: CL(Up to 24 hours after Start of Infusion)
- Carbetocin PK parameters: Vss(Up to 24 hours after Start of Infusion)
- Carbetocin PK parameters: Vz.(Up to 24 hours after Start of Infusion)
- Treatment-emergent adverse events (TEAEs)(Up to follow-up visit (7 to 10 days after the last dose))
- Vital signs; Pulse rate(End of Trial (Up to 25 days))
- Vital signs; Body temperature(End of Trial (Up to 25 days))
- Vital signs; Respiratory rate(End of Trial (Up to 25 days))
- Vital signs; Systolic blood pressure and Diastolic blood pressure(End of Trial (Up to 25 days))
- 12-lead safety ECGs(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Blood Urea Nitrogen(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Bilirubin Total(Up to follow-up visit (7 to 10 days after the last dose))
- Clinical chemistry: Changes in Concentration of Bilirubin direct(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Alkaline phosphatase(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Aspartate aminotransferase(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Alanine aminotransferase(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Albumin(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Sodium(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Potassium(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Magnesium(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Chloride(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Fasting glucose(End of Trial (Up to 25 days))
- Carbetocin PK parameters: AUClast(Up to 24 hours after Start of Infusion)
- Clinical chemistry: Changes in Concentration of Creatinine(End of Trial (Up to 25 days))
- Hematology: Changes in Concentration of Hemoglobin(End of Trial (Up to 25 days))
- Hematology: Changes in Concentration of Hematocrit(End of Trial (Up to 25 days))
- Hematology: Changes in Concentration of Total and differential leukocyte count(Up to follow-up visit (7 to 10 days after the last dose))
- Carbetocin PK parameters: AUCinf(Up to 24 hours after Start of Infusion)
- Hematology: Changes in Concentration of Red blood cell count(End of Trial (Up to 25 days))
- Hematology: Changes in Concentration of Platelet count(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of pH(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of specific gravity(Up to follow-up visit (7 to 10 days after the last dose))
- Urinalysis parameters: Concentration of Protein(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of Glucose(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of Bilirubin(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of Blood(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of Nitrite(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of Urobilinogen(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of Leukocyte esterase(End of Trial (Up to 25 days))
- ∆HR, PR change from baseline (∆PR), RR change from baseline (∆RR), QRS change from baseline (∆QRS), and QTcF change from baseline (∆QTcF), if not selected as the primary endpoint.(Up to 24 hours after Start of Infusion)
- Placebo-corrected ∆HR (∆∆HR), placebo-corrected ∆PR (∆∆PR), placebo-corrected ∆RR (∆∆RR), placebo-corrected ∆QRS (∆∆QRS), and ∆∆QTcF, if not selected as the primary endpoint(Up to 24 hours after Start of Infusion)
- Categorical outliers for QTcF(Up to 24 hours after Start of Infusion)
- Categorical outliers for HR(Up to 24 hours after Start of Infusion)
- Categorical outliers for PR(Up to 24 hours after Start of Infusion)
- Categorical outliers for QRS(Up to 24 hours after Start of Infusion)
- Abnormalities in T wave morphology and pathologic U waves, as appropriate.(Up to 24 hours after Start of Infusion)
- ∆∆QTc (i.e., ∆∆QTcF or the most appropriate HR correction method) following administration of moxifloxacin.(Up to 24 hours after Start of Infusion)
- TEAEs(End of Trial (Up to 25 days))
- Urinalysis parameters: Concentration of Specific gravity(End of Trial (Up to 25 days))
- Clinical chemistry: Changes in Concentration of Bilirubin total(End of Trial (Up to 25 days))
- Hematology: Changes in Concentration of Total and Differential leukocyte count(End of Trial (Up to 25 days))
研究者
研究点 (1)
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