Evidence map›Paper›PMID 36809048›Full record

ArticleAntimicrobial agents and chemotherapy2023

Single-Ascending-Dose, Food-Effect, and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of the Pangenotypic Anti-Hepatitis C Virus Drug Holybuvir in Healthy Chinese Subjects.

Yuran Cao, Xiaojie Wu, Zhiqiang Wang, Yuxian Huang, Junzhen Wu, Guoying Cao, Jicheng Yu, Jingjing Wang, Haijing Yang, Wenhong Zhang and 1 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2023. 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
0.4field-weighted citation impact, top 40% of its field
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, 2 citations in OpenAlex.

  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 at 2 institutions in 1 country.

Yuran CaoPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Xiaojie WuPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.ORCID 0000-0002-0081-6507
Zhiqiang WangNanjing Sanhome Pharmaceutical Co., Ltd., Nanjing, Jiangsu, China.
Yuxian HuangInfectious Disease Department, Huashan Hospital, Fudan University, Shanghai, China.
Junzhen WuPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Guoying CaoPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Jicheng YuPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Jingjing WangPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Haijing YangPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Wenhong ZhangInfectious Disease Department, Huashan Hospital, Fudan University, Shanghai, China.
Jing ZhangPhase I Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.ORCID 0000-0003-2966-9149
Fudan University · CNSimcere Pharmaceutical (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Holybuvir is a novel pangenotypic hepatitis C virus NS5B inhibitor. This first in-human study aimed to evaluate the pharmacokinetics (PK), safety, and tolerability of holybuvir and its metabolites and the effect of food on the PK of holybuvir and its metabolites in healthy Chinese subjects. A total of 96 subjects were enrolled in this study which included (i) a single-ascending-dose (SAD) study (100 to 1,200 mg), (ii) a food-effect (FE) study (600 mg), and (iii) a multiple-dose (MD) study (400 and 600 mg once daily for 14 days). The results showed that single oral administration of holybuvir at doses up to 1,200 mg was well tolerated. Holybuvir was rapidly absorbed and metabolized in the human body, which was consistent with the characteristics of holybuvir as a prodrug. PK analysis showed that

Indexed as

Hepatitis CProdrugsAdministration, OralArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodEast Asian PeopleHealthy VolunteersHepacivirusHumansProdrugsdirect-acting antiviral agenthepatitis Cholybuvirpangenotypicpharmacokineticssafety

Identifiers

PMID36809048
PMCPMC10019294
OpenAlexW4321478834

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.