Evidence map›Paper›PMID 40291342›Full record

ArticleFrontiers in pharmacology2024

Evaluation of drug-drug interaction between Suraxavir Marboxil (GP681) and itraconazole, and assessment of the impact of gene polymorphism.

Mai Han, Gang Cui, Yan Zhao, Xianbo Zuo, Xiaoxue Wang, Xin Zhang, Na Mi, Jiangli Jin, Chunyan Xiao, Jing Wang and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05789342 (A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-drug Interactions), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–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.

NCT05789342 phase1completednot on this map

A Four-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-drug Interactions (DDIs) Between GP681 and Rosuvastatin/Digoxin/Itraconazole/Oseltamivir in Chinese Healthy Volunteers

TypeinterventionalSponsorJiangxi Qingfeng Pharmaceutical Co. Ltd.Ran2023 to 2023Enrolled54ConditionsHealthy VolunteersArmsGP681, Rosuvastatin, Digoxin, Itraconazole, Oseltamivir
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

13 authors.

Mai HanDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Gang CuiDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Yan ZhaoQingfeng Pharmaceutical Group Co., Ltd., Ganzhou, Jiangxi, China.
Xianbo ZuoDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Xiaoxue WangDepartment of Pharmacy, State Key Laboratory of Respiratory Health and Multimorbidity, China-Japan Friendship Hospital, Beijing, China.
Xin ZhangDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Na MiDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Jiangli JinDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Chunyan XiaoDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Jing WangDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Wei WuDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.
Yajuan LiQingfeng Pharmaceutical Group Co., Ltd., Ganzhou, Jiangxi, China.
Jintong LiDrug Clinical Trial Research Center, China-Japan Friendship Hospital, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Suraxavir Marboxil (GP681) is a prodrug metabolized to GP1707D07, which inhibits influenza viral replication by targeting cap-dependent endonuclease through a single oral dose. This study assesses the in vivo drug-drug interaction (DDI) potential between GP681 (including its major metabolite GP1707D07, a substrate of CYP3A4) and itraconazole in healthy Chinese subjects, along with the safety profiles during co-administration. Additionally, it evaluates the impact of CYP1A2, CYP2C19, and CYP3A4 gene polymorphisms on GP1707D07 metabolism. Methods: The study enrolled twelve healthy adult subjects to receive the treatments consisting of GP681 monotherapy and GP681-itraconazole co-administration in a fixed-sequence. Single nucleotide polymorphisms (SNPs) in CYP gene loci were also analyzed. Results: Co-administration of itraconazole increased the GP1707D07 AUC0- Discussion: The pharmacokinetic changes of GP1707D07 during itraconazole co-administration are insufficient to warrant clinical action. Random forest algorithm enhances the understanding of pharmacogenetic variants involved in GP1707D07 metabolism and may serve as a potent tool for assessing gene polymorphism data in small clinical samples. Clinical Trial Registration: clinicaltrials.gov, identifier NCT05789342.

Indexed as

DDI (drug-drug interaction)genetic polymorfismitraconazolepharmacokineticsafetySuraxavir Marboxil (GP681)

Identifiers

PMID40291342
PMCPMC12022903

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Registered trials

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.