ACTRN12614001281684Active, not recruitingPhase 1
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Design Study to Evaluate the Effects of Perhexiline on ECG Parameters in Healthy Subjects
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Heart Metabolics, Ltd.
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Healthy, non-smoking, male or female subjects ages 18 to 55 years inclusive, at the time of informed consent
- •2. Body mass index (BMI) of 18 to 30 kg/m2 inclusive, at Screening
- •3. Females must not be lactating or pregnant at Screening or Baseline
- •4. Provide written informed consent
- •5. Willing and able to comply with all aspects of the protocol
Exclusion Criteria
- •1. CYP2D6 poor metabolizer, as determined via genotype
- •2. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before dosing
- •3. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing
- •4. Any history of gastrointestinal surgery that may affect the pharmacokinetic profile of either study drug
- •5. Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, ECG finding, or laboratory test results that requires medical treatment at Screening or Baseline
- •6. History of any medical condition which, in the opinion of the investigator, may interfere with study procedures or compromise subject safety
- •7. A prolonged QT/corrected QT interval (QTc) interval (QTc > 450 ms), inverted or flat T waves that may interfere with QT analysis at Screening or Baseline, or any other clinically significant ECG abnormalities at Screening or Baseline
- •8. History of risk factors for torsade de pointes or the use of concomitant medications that prolong the QT/QTc interval
- •9. Persistent systolic blood pressure (BP) > 130 mmHg or < 90 mmHg and diastolic BP >85 mmHg or <50 mmHg at Screening or Baseline
- •10. Heart rate < 50 or > 100 beats/minute at Screening
- •11. History of prolonged QT/QTc interval
- •12. History of myocardial infarction or active ischemic heart disease
- •13. History of clinically significant arrhythmia or uncontrolled arrhythmia
- •14. Known history of clinically significant drug allergy (including to study drugs or any of their excipients) at Screening or Baseline
- •15. Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline
- •16. Active viral hepatitis (B or C) as demonstrated by positive serology at Screening
- •17. History of drug or alcohol dependency or abuse within the 2 years before Screening, or who have a positive urine drug or alcohol test at Screening or Baseline
- •18. Use of recreational drugs
- •19. Intake of caffeinated beverages or food within 72 hours before dosing
- •20. Intake of nutritional supplements, juice, and herbal preparations or other foods or beverages that may affect the various drug metabolizing enzymes and transporters (eg., alcohol, grapefruit, grapefruit juice, apple or orange juice, vegetables from the mustard green family) within 1 week before dosing
- •21. Intake of herbal preparations containing St John's Wort within 4 weeks before dosing
- •22. Use of prescription drugs within 4 weeks before dosing
- •23. Intake of over-the-counter (OTC) medications within 2 weeks before dosing
- •24. Smoking or use of tobacco or nicotine-containing products within 4 weeks before dosing
- •25. Engagement in strenuous exercise within 2 weeks before dosing
- •26. Currently enrolled in another clinical trial or used any investigational drug or device within 30 days preceding informed consent
Investigators
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