Trial reportDrug design, development and therapy2026
Effects of Cipepofol on Cardiac Depolarization and Repolarization in Healthy Subjects: A Single-Center, Randomized, Placebo and Positive-Controlled Thorough QT Study.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06379867, which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Who cites it
1 citing paper in PubMed.
- Intra-subject covariates of QT variability indices: influence of ECG noise.Frontiers in physiology · 2026Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
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 < 10 milliseconds at all post-dose timepoints. In addition, no clinically significant effects of cipepofol were observed on the PR interval or QRS interval (ventricular depolarization time). Assay sensitivity was successfully demonstrated by the expected QTc interval prolongation within 2-4 h post-moxifloxacin administration. No subjects in the cipepofol treatment period developed a new QTcI interval >480 or an increase in QTcI interval from baseline >60 milliseconds. All adverse events were mild to moderate in severity, and no serious adverse events or deaths occurred. Conclusion: Cipepofol exhibited no clinically relevant effects on the QTc interval or other ECG parameters, and was safe and well tolerated in healthy subjects. Clinical Trial Registration: This study was registered on ClinicalTrials.gov (NCT06379867).
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