Effect of methoxyflurane on cardiac function in healthy male and female adults
- Conditions
- Effects on Cardiac QT/QTc Interval of an intervention that is used for pain relief.Anaesthesiology - Pain management
- Registration Number
- ACTRN12613000305729
- Lead Sponsor
- Medical Developments International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 39
Healthy male and female subjects, aged 18 to 45 years inclusive, body mass index (BMI) >=18 and <=29 kg/m2, weight >=50 kg, with satisfactory medical history and current conditions, as defined.
- Known cardiovascular disorders
- ECG abnormalities that may reflect underlying heart disease and which may interfere with the accurate assessment of the QT interval
- Known clinically significant arrhythmias or rhythm disturbances
- A history of, or risk factors for Torsades de Pointes
- A supine heart rate at screening outside 45-90 bpm
- Consumption of any medication especially those with a known QT prolongation effect, within 30 days before the first dose of study drug, except occasional paracetamol use (up to 1 g/day).
- Existence of any condition that could possibly interfere with drug absorption
- Significant renal insufficiency, as indicated by an estimated creatinine clearance using the Cockcroft-Gault formula of <75 mL/min (males or females), at screening
- Personal or family history of hypersensitivity to fluorinated anaesthetics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method