NCT02210182已完成1 期
A Phase I Clinical Study on the Hepatic Uptake, Pharmacokinetics, Safety and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects Undergoing Thermal Ablation
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
- 29
- 试验地点
- 3
- 主要终点
- pharmacokinetics
研究概览
简要总结
The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects Undergoing Thermal Ablation
详细描述
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential-group administration of a new oral pentamidine formulation to investigate its hepatic uptake, pharmacokinetics, safety and tolerance in subjects with hepatocellular carcinoma who undergoes thermal ablation procedure
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects
- •18 years of age or older
- •Radiologically established diagnosis of hepatocellular carcinoma (HCC) with tumor diameter ≤ 5 cm
- •Suitable for and scheduled to undergo thermal ablation as treatment
- •Have a Barcelona score of 0 or A
- •Have a Child Pugh score of A or B
- •Legally and mentally able to give informed consent to participate in the study
- •Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects of the trial prior to enrolment
- •Willingness and ability to comply with scheduled visits and trial procedures
排除标准
- •Presence of uncontrolled diabetes, defined as glycated hemoglobin (Hb1Ac) ≥ 8.0
- •History of clinically significant hypoglycaemia, with fasting blood glucose < 3 mmol/L within 3 months prior to signature of ICF
- •Presence of clinically significant renal impairment, defined as a creatinine clearance < 60 mL/min
- •Systolic Blood Pressure < 100 mm Hg (if deemed clinically significant by the treating physician)
- •Current or recent (< 2 years) history of pancreatitis
- •International Normalised Ratio (INR) > 1.5 or presence of severe coagulation disorders (vg but limited to prothrombin activity < 40% or a platelet count of < 40,000 / mm3)
- •Presence of known vascular invasion, bile duct invasion or extrahepatic metastasis
- •Presence of portal venous thrombosis
- •Concomitant therapy with other investigational agents or participation in another clinical trial within 3 months of signature of ICF
- •Previous use of pentamidine with treatment discontinuation of less than 6 months prior to signature of ICF
- •Any of the following conditions: Ongoing clinically significant cardiac dysrhythmias such as atrial fibrillation ; QTc interval > 450 msec for males or > 470 msec for females or uncontrolled intercurrent cardiac illness, e.g. unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia < 50 bpm (unless caused by beta-blocker); a history of additional risk factors for torsades de pointes (e.g., heart failure or family history of Long QTC Syndrome)
- •Presence of clinically significant hypokalemia or hypomagnesemia
- •Concurrent use of nephrotoxic drugs
- •Concurrent use of cardiotoxic drugs
- •Concurrent use of drugs that may be associated with pancreatitis
- •History of allergy or hypersensitivity to pentamidine
- •Pregnancy or breastfeeding. All female subjects of childbearing potential must have a negative urine pregnancy test prior to first dose of study medication.
- •Acute or chronic severe medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial
研究组 & 干预措施
Oral pentamidine
Experimental
Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days
干预措施: Oral Pentamidine (Drug)
Placebo
Placebo Comparator
Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days
干预措施: Placebo (Other)
结局指标
主要结局
pharmacokinetics
时间窗: 3 days
Liver concentration of pentamidine in hepatocellular carcinoma tumor and surrounding tissue after oral administration for 3 days at different doses, measured in liver biopsies obtained during thermal ablation procedure
次要结局
- plasma Pharmacokinetics(3 days)
- Adverse events(3 days)
- markers of efficacy(3 days)
- Biomarker(3 days)
研究者
研究点 (3)
Loading locations...
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