ACTRN12621000718842CompletedPhase 1
A Phase 1, Open-Label, Randomized, Single Dose Study of Flecainide Acetate Inhalation Solution (FlecIH-103) to Flecainide Acetate Intravenous Infusion (Tambocor®) to Compare Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
InCarda Therapeutics Australia Pty Ltd.0 sites19 target enrollmentStarted: June 9, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 19
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •Be males or females, 18 to 55 years of age (inclusive), with body mass index (BMI) between 20 and 32 kg/m2 (inclusive) and a body weight (BW) greater than or equal to 70 kg, no significant medical history, and in good general health as determined by the PI or delegate at the clinical facility.
- •Be non-smokers or former smokers who have not consumed tobacco, e-cigarettes and/or marijuana products within 6 months of Day 1 AND have a less than or equal to 5 pack year previous history. Light smokers who have consumed less than or equal to 5 cigarettes per week within 6 months of Day 1 AND who do not have a 5 pack per year previous history are eligible, but must abstain from smoking for 30 days prior to Day 1. All participants must pass a cotinine urine test to be enrolled.
- •Have no evidence of asthma, chronic obstructive pulmonary disease (COPD) or major pulmonary airway disease, including participants with established pulmonary disease in need of inhalation medication (participants with history of childhood asthma but no subsequent episodes are eligible).
- •Have no history of heart disease, including but not limited to, coronary artery disease, myocardial infarction, heart failure of any cause, clinically significant cardiac arrhythmias and valvular heart disease.
- •Have no previous invasive cardiac procedures (participants having undergone invasive cardiac procedures which definitively demonstrated no cardiac issues are eligible).
- •Have no clinically significant family history of cardiac arrhythmias, acquired or congenital.
- •Have not participated in any other investigational study within 30 days prior to dose administration or within 5 half-lives of the experimental drug (whichever is longer).
- •Have to meet a number of specific cardiovascular (measured with a 12-lead ECG) and hemodynamic parameters, as follows:
- •Heart Rate (HR) greater than 47 bpm
- •PR Interval less than or equal to 190 ms
- •QRS interval less than or equal to 105 ms
- •QTcF (QT interval corrected using Fridericia’s formula) less than or equal to 450 ms for males and less than or equal to 460 ms for females
- •Systolic Blood Pressure (BP) of greater than or equal to 100 to less than or equal to 140 mmHg
- •Diastolic BP of greater than or equal to 60 to less than or equal to 100 mmHg
- •Have no clinical significant abnormalities detected on a standard diagnostic echocardiogram
- •Have to meet a number of specific pulmonary assessments related to pulmonary function testing:
- •FEV1 (forced expiratory volume in 1 second) – report the largest value greater or equal to 80% of normal values
- •FVC (forced vital capacity) – report the largest value greater than or equal to 80% of normal values
- •Normal chest X-ray indicating no clinically significant anomaly
- •Oxygen saturation greater than 95%
- •FEF (forced expiratory flow) 25-75% - report the value from the test with the highest sum of FEV1 + FVC greater than or equal to 70% 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.
Exclusion Criteria
- •1. Evidence of asthma, chronic obstructive pulmonary disease (COPD) or major pulmonary airway disease, including participants with established pulmonary disease in need of inhalation medication; (participants with history of childhood asthma but no subsequent episodes are eligible)
- •2. Evidence of early repolarization pattern in the ECG, defined as elevated J-Point or end-QRS slurring with or without concave ST-segment elevation [MacFarlane, 2015]. A J-Point elevation of greater than or equal to 0.1 mV and prominent end-QRS notch or slur in 2 contiguous ECG leads should be flagged for review by the study cardiologist and/or medical monitor. Minor findings are considered acceptable.
- •3. History of heart disease such as, coronary artery disease, MI, cardiac arrhythmias, valvular heart disease and heart failure.
- •4. Previous invasive cardiac procedures (participants having undergone invasive cardiac procedures which definitively demonstrated no cardiac issues are eligible);
- •5. Clinically significant family history of cardiac arrhythmias, acquired or congenital (e.g., Brugada and/or long-QT syndromes), unexplained sudden cardiac death, and/or unexplained syncope
- •6. Family history of congenital airway lung obstructive disease
- •7. Use of prescription medication or over-the-counter products (including other antiarrhythmic drugs, anticoagulants and BP lowering drugs, medications known to prolong the QTc interval, natural food supplements, vitamins, and garlic as a supplement) within 7 days prior to administration of study treatment, except for topical products without systemic absorption, paracetamol, and/or protocol-compliant contraceptives
- •8. Any contraindications to flecainide as per Tambocor package insert
- •9. Has experienced any symptomatic heart failure (per New York Heart Association [NYHA] guidelines), or history of impaired LVEF.
- •10. Has human immunodeficiency virus infection, as shown by the presence of anti-human immunodeficiency virus (HIV) antibody (sero-positive).
- •11. Is sero-positive for hepatitis B or hepatitis C virus, and/or a history of delta virus hepatitis.
- •12. Has uncontrolled hypertension: Blood pressure (BP) greater than 150/100 mmHg.
- •13. Has a history of torsades de pointes, atrial and/or ventricular rhythm disturbances (e.g., atrial or ventricular tachycardia or fibrillation), sinus bradycardia (less than or equal to 47 bpm), Cardiac Conduction Disease (AV Nodal Block or PR interval greater than 190 ms), congenital long QT syndrome or new ST segment elevation or depression or new Q wave on ECG.
- •14. Has had episodes of syncope, including during blood draw.
- •15. Currently abuses and/or has a history of alcohol and/or drug abuse less than 12 months from Screening.
- •16. Regularly uses excessive alcohol within six months prior to the Screening visit (i.e., more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40 % alcohol]).
- •17. Has a positive standard 10x panel drug test at Screening and/or has a history of drug abuse within 12 months from Screening.
- •18. Use of investigational agents or devices within 30 days or 5 half-lives (whichever is longer) prior to planned study dosing or current participation in an investigational study
- •19. Has a clinically significant history or presence of any gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), liver or kidney disease, or other
Investigators
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