NCT01424540已完成1 期
A Randomized, Double Blind, Single Dose, Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805 in Healthy Adult Volunteers
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
- 20
- 试验地点
- 1
- 主要终点
- Number of subjects with a change in ejection fraction greater than 10 percent
研究概览
简要总结
This is a single-center, randomized, two part, double-blind, crossover study in healthy adult subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function comparing with placebo using echocardiography as a primary assessment modality
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin less than or equal to 1.5xUpper Limit of Normal (ULN).
- •Healthy as determined by a responsible and experienced physician, based on a medical evaluation including [medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- •Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- •A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, oophorectomy, or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
- •Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
- •Body weight greater than or equal to 50 kilogram (kg) for men and 45 kg for women. Body mass index (BMI) between 18.5-30 inclusive will be allowed.
- •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Subject has demonstrated an adequate echocardiographic window.
- •QTcB less than 450 milliseconds (msec).
排除标准
- •A positive pre-study Hepatitis B surface antigen,positive Hepatitis C antibody, or a positive test for HIV antibody result within 3 months of screening.
- •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •A positive pre-study drug/alcohol screen.
- •History of regular alcohol consumption within 6 months of the study.
- •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- •Where participation in the study would result in donation of blood or blood products in excess of 500 mililiters within a 56 day period.
- •Pregnant females as determined by positive [serum or urine] hCG test at screening or prior to dosing.
- •Lactating females.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •Subject is mentally or legally incapacitated.
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Subjects who have asthma or a history of asthma.
- •Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- •Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication.
- •Left ventricular ejection fraction less than 55% at screening.
- •The subject's systolic blood pressure is outside the range of 90-140, or diastolic blood pressure is outside the range of 45-90 or heart rate is outside the range of 50-100beats per minute for female subjects or 45-100 beats per minute for male subjects.
- •Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination):
- •Males-Heart rate less than 45 and greater than 100 beats per minute (bpm). Females-Heart rate less than 50 and greater than 100 bpm Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
- •Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome). Sinus Pauses greater than 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject. Non-sustained or sustained ventricular tachycardia ( greater than or equal to 3 consecutive ventricular ectopic beats).
研究组 & 干预措施
Treatment A
Experimental
GSK2336805 150mg
干预措施: GSK2336805 150mg (Drug)
Treatment B
Placebo Comparator
GSK2336805 Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of subjects with a change in ejection fraction greater than 10 percent
时间窗: 10 hours
Echocardiographic measures of contractility
次要结局
- Correlation between concentration and various safety parameters(24 hours)
- Area under the curve (0-24)(24 hours)
- Concentration at 24 hours(24 hours)
- Troponin lab results(24 hours)
- Terminal phase half-life(24 hours)
- Lag time before observation of drug concentrations in sampled matrix(24 hours)
- Number of subjects using concurrent medication(24 hours)
- Number of subjects with laboratory values out of range(24 hours)
- Maximum observed concentration (Cmax)(24 hours)
- Time of occurrence of Cmax(24 hours)
- B-type natriuretic peptide (BNP) lab result(24 hours)
- Number of subjects with electrocardiogram (ECG) parameters out of range(3 hours)
- Number of subjects with vital signs out of range(24 hours)
- Number of subjects with adverse events(24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult SubjectsHealthy VolunteersNCT03206229Adello Biologics, LLC120
已完成
不适用
Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic FibrosisCystic FibrosisExocrine Pancreatic InsufficiencyNCT04966897GlycosBio, Inc.10
已完成
3 期
A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With AsthmaExercise Induced BronchospasmNCT04234464Bond Avillion 2 Development LP60
已完成
3 期
Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII DeficiencyFactor VII DeficiencyNCT03079063AryoGen Pharmed Co.24
已完成
1 期
Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)BioequivalenceNCT02385851Coherus Biosciences, Inc.116