Trial reportAnnals of medicine2022
Safety, pharmacokinetics and pharmacodynamics of a novel γ-aminobutyric acid (GABA) receptor potentiator, HSK3486, in Chinese patients with hepatic impairment.
Trial report in Annals of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04145596 (A Phase 1 Study to Investigate a Single Bolus Dose Followed With a 30 Minute Constant Infusion of HSK3486 on the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment), which is not on this map. Cited by 13 papers.
What it found
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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.
A Phase 1 Study to Investigate a Single Bolus Dose Followed With a 30 Minute Constant Infusion of HSK3486 on the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group)
Who cites it
13 citing papers in PubMed.
- Age-related reduction in ciprofol requirement for loss of consciousness during anesthesia induction: a prospective cohort study.Frontiers in medicine · 2026Trial
- A Comparative Study of Pharmacokinetics and Pharmacodynamics of Continuous Ciprofol Infusion Between Young and Elderly Patients.Drug design, development and therapy · 2026Trial
- Comparative effective dose of ciprofol and propofol in suppressing cardiovascular responses to tracheal intubation.Scientific reports · 2025Trial
- Effect of Ciprofol on Postoperative Cognitive Function in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial.Drug design, development and therapy · 2025Trial
- ED50 of ciprofol combined with sufentanil for fiberoptic bronchoscopy of different patient populations with pulmonary tuberculosis.BMC anesthesiology · 2024Trial
- Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Cipepofol Across Diverse Clinical Populations.Pharmaceutics · 2026Article
- Population pharmacokinetics of a single bolus of ciprofol in Chinese pediatric patients.BMC anesthesiology · 2026Article
- Pharmacological mechanism and clinical application of ciprofol.Frontiers in pharmacology · 2025Review
- Pharmacokinetics and exposure-safety relationship of ciprofol for sedation in mechanically ventilated patients in the intensive care unit.CPT: pharmacometrics & systems pharmacology · 2024Article
- Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial.Frontiers in medicine · 2024Article
- Article
- Pharmacokinetics, pharmacodynamics, and safety of ciprofol emulsion in Chinese subjects with normal or impaired renal function.Frontiers in pharmacology · 2023Article
- Efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil during fiberoptic bronchoscopy: A prospective, randomized, double-blind, non-inferiority trial.Frontiers in pharmacology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe primary objective of this study was to investigate if hepatic impairment alters the safety, pharma RESEARCH DESIGN AND
methodsThis was a clinical trial of HSK3486 in subjects with normal hepatic function (
resultsIn total, 24 subjects were enrolled and completed the study. HSK3486 was generally well tolerated by all subjects. There were no serious AEs and no deaths reported during the study. The incidence of AEs was numerically highest in subjects with moderate hepatic impairment. The exposure (AUC) of HSK3486 increased gradually with the decrease in hepatic function; however, degree of hepatic impairment had little effect on HSK3486 PD (MOAA/S and BIS).
conclusionsOverall, there were no clinically relevant differences in HSK3486 exposure or PD in subjects with mild or moderate hepatic impairment compared to normal control. These data imply that HSK3486 dose adjustment is not warranted in subjects with mild or moderate hepatic impairment.
trial registrationThe trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04145596).Key MessageHSK3486 at an IV bolus dose of 0.4 mg/kg and a maintenance infusion of 0.4 mg/kg/h was safe and well tolerated by all mild or moderate hepatic impairment subjects and normal hepatic function subjects.There were no clinically relevant differences in HSK3486 exposure or PD in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function.HSK3486 dose adjustment is not required in subjects with mild or moderate hepatic impairment.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.