NCT00964730已完成1 期
A Phase I, Single-Center, Double-Blind, Randomized, Placebo- and Positive- Controlled, Parallel Group, Thorough QT/QTc Study to Evaluate the Effect of Talampanel on Cardiac Repolarization in Healthy Male and Female 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
- 135
- 试验地点
- 1
- 主要终点
- To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days
研究概览
简要总结
The purpose of this study is to assess whether multiple doses of Talampanel increase the QT interval when compared to placebo
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 18 to 50 years of age inclusive.
- •Body mass index: Between 18 and 30 kg/m2 and weight of at least 50 kg.
- •Female volunteers must have either a negative pregnancy test and be willing to use birth control, be post-menopausal evidenced by lab test, or be surgically sterile.
- •Volunteers must be able to understand the requirements of the study and must be willing to comply with the requirements of the study and provide their written informed consents to participate in the study prior to the conduct of study procedures.
排除标准
- •Male and female volunteers with a resting QT interval of < 320 msec or > 450 msec (males) or > 470 msec (females
- •Volunteers with ECG abnormalities that may interfere with the accurate assessment of the QT interval
- •Volunteers with known cardiovascular disorders, including coronary artery disease, valvular heart disease, cardiomyopathies, or ECG abnormalities suggestive of prior myocardial infarction, chamber enlargement or hypertrophy.
- •Volunteers with known clinically significant arrhythmias or rhythm disturbances observed on ECG
- •Volunteers who have a history of, or risk factors for, Torsades de Pointes (e.g. heart failure, abnormal serum electrolytes), including a history of family history of arrhythmia, sudden death, long QT syndrome, Brugada complex, or personal history of syncope.
- •Volunteers who have a heart rate outside 40-90 beats per minute
- •Volunteers who have a blood pressure outside 90-140 mmHg systolic or 45-90 mmHg diastolic
- •Volunteers with history of uncontrolled hypertension, impaired glucose tolerance, diabetes mellitus, kidney disease, edema, stroke or neurological disorder, rheumatological disorder, lung disease, heart disease, liver disease, or a history of any illness that pose additional risk to the volunteer
- •Volunteers with a history of psychiatric disorders, including bipolar disorder, psychosis, previous episode(s) of major depression, history of suicidality or suicidal ideation.
- •Volunteers who have history of surgeries or conditions that affect the way drugs are absorbed or distributed in the body such as intestinal surgery, stomach surgery.
- •Volunteers with impaired liver function and elevated liver enzymes
- •Volunteers with major trauma or surgery in the past 2 months, acute infection within 2 weeks, cancer within the last 5 years (excluding non-melanoma skin cancers), History of tuberculosis, abnormal lab tests
- •Female volunteers who are lactating or intend to become pregnant during the study period.
- •Volunteers with a known allergy or sensitivity to moxifloxacin or its derivatives, benzodiazepines, talampanel or its derivatives, or any contraindications to moxifloxacin, benzodiazepines, or talampanel.
- •Volunteers with significant food or drug allergies
- •Volunteers that have used an investigational drug (new chemical entity) 3 months prior to the start of the study,.who have consumed any medications (including over-the-counter medications, prescription medications, investigational drugs, vitamins, or herbal remedies) within 30 days prior to check-in (with the exception of hormonal contraceptives [females only] and occasional use of acetaminophen and ibuprofens, who have consumed amiodarone and chloroquine within 4 months prior to screening, who have consumed excessive amounts of alcohol or are unwilling to comply with the restricted use of alcohol during the study, who have consumed excessive amounts of coffee, tea, coke, or other caffeinated beverages within 2 weeks prior to check-in, who have consumed quinine (tonic water) within 7 days prior to study start, who have consumed grapefruit, grapefruit juice, or Seville orange juice within the 7 days prior to study start, who smoke, have smoked in the last 3 months, or are planning to start smoking during the study, tobacco users, subjects currently using nicotine products, or subjects with a positive urine cotinine test at study start
- •Volunteers who are currently regular users (including recreational use) of any illicit drugs or who have a history of drug (including alcohol) abuse within 1 year of study start.
- •Volunteers with positive urine test for drugs of abuse at screening or check-in.
- •Volunteers who have donated or received any blood, plasma, or platelet transfusions in the 3 months prior to study start, or who have made donations on more than two occasions within the 12 months preceding the first dose administration, or who have planned donations during the study or during the 3 months following the study.
- •Volunteers with a positive screening test for Hepatitis B, Hepatitis C or HIV
- •Volunteers not willing to refrain from changing level of activity during the study and from jogging and strenuous exercise of all types while at the research unit
研究组 & 干预措施
Talampanel
Experimental
干预措施: Talampanel (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Moxifloxacin
Other
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
To determine the effects of Talampanel on cardiac repolarization after multiple therapeutic doses administered over 10 days
时间窗: 12 days
次要结局
- Examine the PK profile of talampanel and its metabolite -Assess the PK/PD relationship of the time course of QT/QTc interval prolongation-Assess the safety and tolerability of multiple doses of talampanel in healthy volunteers(12 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of QT and QTc Intervals in Patients Administered Extended Release Paliperidone or QuetiapineSchizophreniaSchizoaffective DisorderNCT00791622Johnson & Johnson Pharmaceutical Research & Development, L.L.C.110
已完成
1 期
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast CancerMalignant Neoplasm of BreastNCT03366428Daiichi Sankyo Co., Ltd.51
已完成
1 期
Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy SubjectsHealthyNCT01140425Pfizer44
已完成
1 期
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic DrugsHealthyNCT01871701Seoul National University Hospital40
已完成
1 期
TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed ConditionsHealthy VolunteerNCT01291563Tibotec BVBA88