Evidence map›Paper›PMID 39707020›Full record

Trial reportThe AAPS journal2024

Pharmacokinetic-pharmacodynamic Modelling of NH600001 in Healthy Subjects and Patients Undergoing Gastroscopy.

Yaxin Liu, Yun Kuang, Jie Huang, Dan Jiang, Yajie Cao, Qi Gao, Zifeng Li, Wen Ouyang, Saiying Wang, Qi Pei and 1 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The AAPS journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Yaxin LiuCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Yun KuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Jie HuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Dan JiangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Yajie CaoCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Qi GaoCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Zifeng LiCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.
Wen OuyangDepartment of Anesthesiology, The Third Xiangya Hospital, Central South University, Changsha, China.
Saiying WangDepartment of Anesthesiology, The Third Xiangya Hospital, Central South University, Changsha, China.
Qi PeiDepartment of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, China. peiqi1028@126.com.
Guoping YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China. ygp9880@126.com.ORCID 0000-0001-5930-586X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

NH600001 is a new general anaesthetic drug with a structure similar to etomidate. The objective of this study was to investigate the relationship between concentrations of NH600001 and sedation efficacy based on data from phase I-II studies and factors influencing the pharmacokinetics and pharmacodynamics of NH600001. The dataset consisted of 2 phase I studies in healthy subjects and 1 phase II study in patients undergoing gastroscopy. Nonlinear mixed effects modeling was used in developing the population pharmacokinetics and pharmacodynamics (PopPK/PD) model of NH600001. Three-compartment model was used to describe the PK profile of NH600001. Parameters were used for allometric scaling on body weight, where the exponents were set to 0.75 for clearance and 1 for volumes. Co-administration of alfentanil hydrochloride influenced the distribution volume of the central compartment and clearance. Effect of patients undergoing gastroscopy (compared with healthy subjects) on clearance, the distribution volume of the superficial peripheral compartment and inter-compartmental clearance for deep peripheral compartment and central compartment was included the final PopPK model. The effect compartment model well characterized the PK/PD relationship of NH600001. Simulation results showed that an initial dose of 0.25 mg/kg of NH600001 resulted in rapid sedation, and three additional doses at 5-min intervals could maintain sedation for more than 20 min. A PopPK/PD model was successfully constructed for NH600001 in healthy subjects and in patients undergoing gastroscopy that could inform the dosing regimens of the forthcoming phase III study.

Indexed as

GastroscopyModels, BiologicalAdultAgedAlfentanilFemaleHealthy VolunteersHumansHypnotics and SedativesMaleMiddle AgedYoung AdultAlfentanilHypnotics and Sedativesgastroscopic sedationgeneral anaesthetic drugsmodel-informed drug developmentpopulation pharmacokinetic/pharmacodynamic modelling

Identifiers

PMID39707020

What OpenQuestion holds

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Registered trials

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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.