ACTRN12616001156471已完成1 期
A Phase 1, Double-Blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Flecainide Acetate Inhalation Solution to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
InCarda Therapeutics Australia0 个研究点目标入组 44 人开始时间: 2016年8月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •To be eligible for randomization, the participants must meet the following criteria:
- •1.Be male (ages 18 to 35 years inclusive) or female (ages 18 to 50 years inclusive) at the time of screening;
- •2.Be female and of non-childbearing potential (e.g. post menopausal as demonstrated by FSH or surgical sterilization . i.e., tubal ligation or hysterectomy); males should wear condoms with female partners also using an acceptable form of contraception ;
- •3.Normal healthy volunteers with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- •4.Have a BMI between 20 and 28 kg/m2, and a BW of 60-90 kg (for the dose range 20-70 mg) and 65-85 kg (for participants receiving 110 mg), inclusive;
- •5.No significant medical history, and in good general health;
- •6.Have no electrocardiographic abnormalities during a 12-Lead ECG screening and/or pre-dose assessment (measured after the participant is semi-recumbent for at least 5 minutes) that, in the opinion of the PI (or delegate), may compromise the participant’s safety in the study. Final study eligibility for the ECG criteria is to be approved by the PI and/or the SC;
- •7.Have no clinically significant abnormalities detected on a standard diagnostic echocardiogram;
- •8.Non-smokers (including tobacco, e-cigarettes and marijuana) – tested for the absence of cotinine in urine; Non-smokers with significant history of smoking, >5 pack years, are not eligible;
- •9.Be willing and able to comply with all study assessments and adhere to the protocol schedule;
- •10.Have suitable venous access for blood sampling;
- •11.Have ALT and AST within the normal range and Cockcroft-Gault estimated creatinine clearance >70 ml/min;
- •12.Have no abnormal finding of clinical relevance at the screening evaluation.
- •Participants with baseline pulmonary parameters that are borderline as the values listed in this table may be excluded at the discretion of the PI and/or SC.
- •ParameterBaseline enrollment criteria
- •*FEV1 (Forced Expiratory Volume in 1 second)FEV1 greater than or equal to 80% of normal values
- •*FVC (Forced Vital Capacity) FVC greater than or equal to 80% of normal values
- •FEF25-75% - report the value from the test with the highest sum of FEV1 + FVCgreater than 75% of predicted.
- •The average expired flow over the middle half of the FVC maneuver. It is regarded as a more sensitive measure of small airways narrowing than FEV1.
- •Chest X-rayNormal chest X-ray indicating no anomaly
- •Oxygen saturation monitor (performed before dosing and monitored every 15 mins up to 2hours than regularly until discharge)greater than 95%
- •*Report the largest value
- •http://www.nationalasthma.org.au/uploads/content/211-spirometer_handbook_naca.pdf
- •Inclusion and repeatability criteria for pulmonary function testing:
- •*Participants with less than 80% of predicted values will be excluded using Knudson 1976 similar to NIOSH - http://www.cdc.gov/niosh/topics/lung spirometry/refcalculator.html
- •*Obtain 3 acceptable tests, i.e. each test should meet the stated acceptability criteria. http://www.nationalasthma.org.au/uploads/content/211-spirometer_handbook_naca.pdf
- •*The two largest values for FVC should agree to within 0.15L
- •*The two largest values for FEV1 should agree to within 0.15L
排除标准
- •Participants with ECG parameters that are borderline of the values listed in this table may be excluded at the discretion of the PI and/or the SC.
- •ParameterBaseline enrollment criteria
- •Heart Rate (HR)greater than or equal to 55 bpm (to 50bpm)
- •QRS intervalless than 100 ms (to 105 ms)
- •Systolic BPgreater than or equal to 100 to less than or equal to 160 mmHg
- •nclusion and repeatability criteria for pulmonary function testing:
- •*Participants with less than 80% of predicted values will be excluded using Knudson 1976 similar to NIOSH - http://www.cdc.gov/niosh/topics/lung spirometry/refcalculator.html
- •*Obtain 3 acceptable tests, i.e. each test should meet the stated acceptability criteria. http://www.nationalasthma.org.au/uploads/content/211-spirometer_handbook_naca.pdf
- •*The two largest values for FVC should agree to within 0.15L (this criteria has been removed)
- •*The two largest values for FEV1 should agree to within 0.15L (this criteria has been removed)
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