Effects of Cipepofol on Cardiac Depolarization and Repolarization in Healthy Subjects: A Single-Center, Randomized, Placebo and Positive-Controlled Thorough QT Study
Abstract
BACKGROUND: Cipepofol (HSK3486), a gamma-aminobutyric acid type A (GABAA) receptor agonist, has garnered considerable attention as a potential alternative to propofol. This study aimed to evaluate the effects of a single intravenous (IV) bolus dose of cipepofol (0.4 mg/kg) on QTc interval in healthy subjects.
PATIENTS AND METHODS: This was a single-center, randomized, blinded (except for moxifloxacin), placebo- and positive-controlled study with a six-sequence, three-period crossover study. Subjects were randomized to 1 of 3 treatment groups in each period: Group A (placebo); Group B (single dose of 0.4 g moxifloxacin, positive control); and Group C (cipepofol [HSK3486], 0.4 mg/kg via IV bolus). The primary endpoint was the change-from-baseline in QTc interval, corrected for heart rate (HR) using the individual QT correction method (QTcI) - ΔQTcI. Secondary endpoints included change-from-baseline in other electrocardiographic (ECG) parameters. Safety/tolerability and pharmacokinetics of cipepofol were also assessed.
RESULTS: Forty-eight subjects were randomized, and demographic characteristics were comparable across the six sequences. The LS mean placebo-corrected ΔQTcI (ΔΔQTcI) interval following cipepofol bolus ranged from -1.7 to 4.1 milliseconds. The upper bound of the two-sided 90% confidence interval for ΔΔQTcI interval remained 480 or an increase in QTcI interval from baseline >60 milliseconds. All adverse events were mild to moderate in severity, and no serious…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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