NCT01532115已完成1 期
A Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women
Bial - Portela C S.A.1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年5月最近更新:
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
- 64
- 试验地点
- 1
- 主要终点
- Number and percentage of subjects with ECG abnormalities
研究概览
简要总结
The purpose of this study is to evaluate the effect of BIA 9-1067 on the cardiac repolarization in adult healthy men and women volunteers.
详细描述
Single-centre, randomized, double-blind, placebo-controlled and open-label active-controlled, 4-period crossover trial in healthy male and female subjects
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A signed and dated informed consent form before any study-specific screening procedure was performed,
- •Healthy male or female 18 to 55 years of age. Women had to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation or bilateral oophorectomy at least 6 months prior to enrollment); using an intrauterine device; a non-hormonal double barrier contraceptive method (i.e., diaphragm or spermicide plus male condom) for the duration of the trial and with a negative pregnancy test at screening and upon each check-in to the study facility,
- •Had a BMI within the range of 18-30 kg/m2,
- •Able to communicate effectively with the study personnel,
- •Had no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on admission to the clinic,
- •Had a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction,
- •Non-smokers or ex-smokers for at least 3 months,
- •Adequately informed of the nature and risks of the study and gave written informed consent prior to study entry.
排除标准
- •Known hypersensitivity or allergy to moxifloxacin, BIA 9-1067 or related compounds such as tolcapone or entacapone,
- •Women who were pregnant or breastfeeding,
- •Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might have compromised the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might have interfered with the absorption, distribution, metabolism or excretion of study drug, or would have placed the subject at increased risk,
- •A sustained supine systolic blood pressure > 140 mmHg or < 100 mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline,
- •A resting ECG heart rate of < 50 bpm or > 100 bpm,
- •An abnormal screening ECG indicating a second- or third-degree AV block, or one or more of the following: QRS > 110 milliseconds (ms), QTc (Fridericia correction) > 450 ms for male and 470 ms for females, PR interval > 240 ms. Any rhythm other than sinus rhythm, which was interpreted by the Investigator to be clinically significant,
- •The presence of abnormal laboratory values which were considered clinically significant by the Investigator,
- •Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2),
- •Received an investigational drug within a period of 30 days prior to enrolment in the study,
- •Received any drug therapy, excluding hormonal contraceptives, within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion was extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism,
- •Consumption of alcohol within 48 hours prior to dose administration or during any inpatient period,
- •A positive urine drug screen including or a positive alcohol breath test,
- •Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction,
- •A history of difficulty with donating blood,
- •Donated blood or blood products within 45 days prior to enrollment,
- •History of tendonitis or tendon rupture associated with treatment with quinolone antibiotics,
- •Subjects with, or with a history of, additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or a family history of long QT syndrome or family history of sudden death.
研究组 & 干预措施
BIA 9-1067
Experimental
干预措施: BIA 9-1067 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
moxifloxacin
Active Comparator
干预措施: moxifloxacin (Drug)
结局指标
主要结局
Number and percentage of subjects with ECG abnormalities
时间窗: 56 days
Through standard 12-lead ECGs assess the effect BIA 9-1067 on heart rate(HR),These ECGs were centrally reviewed. Cardiac effects were assessed through an evaluation of QT, QTc (QTcI, QTcB, and QTcF), PR, QRS interval duration, HR, and morphological changes.
次要结局
- Number of participants with Adverse Events(56 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mgParkinson DiseaseNCT03097211Bial - Portela C S.A.38
已完成
1 期
Effect of BIA 6-512 at Steady-state on the Levodopa PharmacokineticsParkinson DiseaseNCT03094156Bial - Portela C S.A.39
已完成
1 期
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)Chronic Obstructive Pulmonary Disease (COPD)AsthmaNCT05830071Chiesi Farmaceutici S.p.A.95
已完成
1 期
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy ParticipantsHealthy VolunteerNCT06574828Biogen69
已完成
1 期
Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy SubjectsHealthyNCT00434395Bausch Health Americas, Inc.