NCT03362853已完成1 期
A Randomized, Single-center, Placebo and Positive Control, 4-period and 4-crossover Clinical Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Malate Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects as Well as the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics
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
- 48
- 主要终点
- ECG analysis - baseline-adjusted mean QTcF
研究概览
简要总结
A randomized, single-center, placebo and positive control, 4-period and 4-crossover clinical study with the following main purposes: (1) To evaluate the effect of a single-dose oral administration of nemonoxacin malate capsule on QTc intervals and heart rhythms of healthy subjects. (2) To evaluate the influence of food intake on QTc intervals and pharmacokinetic characteristics.
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
Stage I: the administration sequences of the 4 groups were CABD, ADCB, BCDA and DBAC respectively. D represents moxifloxacin, the positive control drug, for which an open design was adopted. For the other 3 groups, i.e. 500 mg nemonoxacin, 750 mg nemonoxacin, and placebo, a double-blind design was employed.
Stage II: An open design for 12 subjects who had completed Stage I to receive a single oral dose of 500 mg nemonoxacin after taking a high-fat test meal
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged between 18 and 40 during the screening period.
- •A volunteer's Body Mass Index (BMI) had to be between 19~24 kg/m2, and a male volunteer's body weight was no less than 50 kg, while female, no less than 45 kg.
- •A subject was judged as a healthy one by investigators according to his/her medical history, physical examination, 12-lead ECG examination, and laboratory test results.
- •A female subject:
- •was post-menopausal for at least 1 year, or
- •had been surgically sterilized, or
- •met the following conditions if she was fertile: (i)her urine pregnancy test results were negative before she started the trial, and (ii)she agreed to use an approved birth control method (e.g. oral contraceptive, spermicide, condom, or intrauterine contraceptive device) throughout the study, and agreed to continue using birth control method within 1 month after the study, and (iii)she may not breastfeed.
- •A male subject had to use a reliable birth control method (using a condom, or his partner executed the foresaid criteria) throughout the study and within 1 month after the study.
- •A subject had never used tobacco or nicotine products within 1 month before receiving the study drug.
- •A subject had never drunk alcohol or drunk more than 12 times within 3 months before receiving the study drug.
- •A subject was willing to completely abstain from foods or beverages containing caffeine or xanthine such as coffee, tea, chocolate, alcohol, grapefruit juice, orange juice, etc within 24 hours before receiving the study drug and during his/her Stage I ward stay.
- •A subject was willing to sign the Informed Consent Form.
排除标准
- •had any personal or family history of sudden cardiac death, myocardial ischemia, myocardial infarction, congestive heart failure, long QT syndrome, hypokalemia, myocarditis, exertional dyspnea, cerebrovascular accident, venous thromboembolism, etc; or
- •needed to use medicine to treat QTc interval prolongation (e.g. Category I or III antiarrhythmic drugs, please refer to Appendix 1) or medicine to treat heart disease; or
- •was found to have abnormal mean values of parameters in 12-lead ECG during the screening: PR >240 ms, QRS >110 ms, male QTcF >430 ms (the automated machine-derived QTcF results in Lead II ECG were used and needed to be confirmed by the investigators), female QTcF >450 ms (the automated machine-derived QTcF results in Lead II ECG were used and needed to be confirmed by the investigators), bradycardia (heart rate <50 bpm); or
- •had clinical abnormalities in 12-lead ECG during screening (e.g. atrioventricular block, torsades de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, clinically significant T wave changes, or any 12-lead ECG abnormalities that may influence QTc intervals); or
- •had systolic blood pressure >140 mmHg or <90 mmHg, diastolic blood pressure >90 mmHg, pulse <50 bpm or >100 bpm during the screening; or
- •had a positive result in hepatitis B virus or hepatitis C virus serology test; or
- •had a positive pregnancy test result or was currently in lactation period; or
- •was found to have any laboratory test value that was outside the reference value (normal value±10%) during the screening, and that was deemed to have clinical significance by investigators; or
- •had a history of diabetes or cardiovascular disease, liver disease or kidney disease; or
- •had malabsorption syndrome or any other gastrointestinal disease that may influence drug absorption; or
- •had any history of epileptic seizures, or mental disease that may affect protocol compliance, or had a suicidal risk, or had history of alcohol or prohibited drug abuse; or
- •had any disease known to severely affect the immune system, e.g. history of human immunodeficiency virus (HIV) infection, hematologic or solid organ malignancy, or had a splenectomy, etc; or
- •had a hypersensitive idiosyncrasy or hypersensitivity to any drugs, including quinolones or fluoroquinolones; or
- •had a surgery or trauma history within 6 months before receiving the study drug; or
- •had, as shown from his/her medical history, used any known liver enzyme inducer or liver enzyme inhibitor such as benzedrine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine, etc within 30 days before receiving the study drug; or
- •had used any other trial drugs within 30 days before receiving the study drug; or
- •had used any prescription drugs or Chinese herbal medicines within 14 days before receiving the study drug; or
- •had used any OTC drugs or nutrition supplements (including the products containing multivalent cation such as calcium, aluminum, magnesium, iron, and zinc, as well as sucralfate, antacids, nutrition supplements, vitamin complex, and dietary metal supplements, etc) within 7 days before receiving the study drug; or
- •had donated ≥400 ml of blood within 3 months before drug administration; or
- •had, as judged by the investigators, any past or current disease or physical condition that may affect the safety or effect evaluation of the study drug; or
- •was identified by the investigators as unsuitable to participate in the study.
研究组 & 干预措施
Nemonoxacin 750Mg Capsule
Experimental
干预措施: Nemonoxacin 500Mg Capsule (Drug)
Nemonoxacin 750Mg Capsule
Experimental
干预措施: Moxifloxacin 400Mg Tablet (Drug)
Nemonoxacin 500Mg Capsule
Experimental
干预措施: Nemonoxacin 500Mg Capsule (Drug)
Nemonoxacin 500Mg Capsule
Experimental
干预措施: Moxifloxacin 400Mg Tablet (Drug)
Nemonoxacin 500Mg Capsule
Experimental
干预措施: Nemonoxacin 750Mg Capsule (Drug)
Nemonoxacin 750Mg Capsule
Experimental
干预措施: Nemonoxacin 750Mg Capsule (Drug)
Nemonoxacin 500Mg Capsule
Experimental
干预措施: Placebo oral capsule (Drug)
Nemonoxacin 750Mg Capsule
Experimental
干预措施: Placebo oral capsule (Drug)
Placebo oral capsule
Placebo Comparator
干预措施: Nemonoxacin 500Mg Capsule (Drug)
Placebo oral capsule
Placebo Comparator
干预措施: Moxifloxacin 400Mg Tablet (Drug)
Placebo oral capsule
Placebo Comparator
干预措施: Nemonoxacin 750Mg Capsule (Drug)
Placebo oral capsule
Placebo Comparator
干预措施: Placebo oral capsule (Drug)
Moxifloxacin 400Mg Tablet
Active Comparator
干预措施: Nemonoxacin 500Mg Capsule (Drug)
Moxifloxacin 400Mg Tablet
Active Comparator
干预措施: Moxifloxacin 400Mg Tablet (Drug)
Moxifloxacin 400Mg Tablet
Active Comparator
干预措施: Nemonoxacin 750Mg Capsule (Drug)
Moxifloxacin 400Mg Tablet
Active Comparator
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
ECG analysis - baseline-adjusted mean QTcF
时间窗: 2 days
To compare the post-dosing placebo-corrected, baseline-adjusted mean QTcF differences (ΔΔQTcF) of nemonoxacin 500 mg/750 mg groups and placebo group at corresponding time points with the manually measured QTcF in Lead II of ECG.
次要结局
- Time at Which Maximum Plasma Concentration was Observed (Tmax)(2 day)
- ECG analysis - baseline-adjusted mean QTcB(2 days)
- Oral Clearance (CLt/F)(2 day)
- Safety analysis(33 days)
- Area Under the Plasma Concentration-Time Curve Calculated to the Last Measured Concentration (AUC(0~t))(2 day)
- half-life (t1/2)(2 day)
- ECG analysis - baseline-adjusted mean QTcP(2 days)
- Lambda-z (λz)(2 day)
- Maximum Plasma Concentration (Cmax)(2 day)
- Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC(0~∞))(2 day)
研究者
相似试验
进行中（未招募）
1 期
Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy SubjectsHealthy SubjectNCT05660720Beijing InnoCare Pharma Tech Co., Ltd.48
已完成
2 期
723/726 Proof of Concept Study in Allergen Challenge Chamber in HannoverRhinitis, Allergic, SeasonalNCT00972504GlaxoSmithKline54
已完成
1 期
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy VolunteersDry Eye SyndromeNCT01162954Dong-A ST Co., Ltd.
已完成
4 期
A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge ChamberRhinitis, Allergic, PerennialAllergic RhinitisNCT00848965GlaxoSmithKline59
已完成
2 期
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic DermatitisAtopic DermatitisPruritusNCT04018027Cara Therapeutics, Inc.401