Evidence map›Paper›PMID 39673613›Full record

ArticleCancer chemotherapy and pharmacology2024

Absorption, metabolism, and excretion of oral [

Sheng Ma, Ling Yi, YiCong Bian, Binhua Lv, Cong Zhang, Chengwei Li, Hua Zhang, Liyan Miao

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 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. Article
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

8 authors.

Sheng MaDepartment of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou, 215031, China.
Ling YiDepartment of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou, 215031, China.
YiCong BianDepartment of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou, 215031, China.
Binhua LvZelgen Biopharmaceuticals Co., Ltd, Suzhou, 215347, China.
Cong ZhangZelgen Biopharmaceuticals Co., Ltd, Suzhou, 215347, China.
Chengwei LiZelgen Biopharmaceuticals Co., Ltd, Suzhou, 215347, China.
Hua ZhangDepartment of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou, 215031, China. zhanghua_suzhou@163.com.
Liyan MiaoDepartment of Pharmacy, The First Affiliated Hospital of Soochow University, Suzhou, 215031, China. miaoliyan@suda.edu.cn.

Funding

Jiangsu Provincial Key Research and Development Program BE2021644Jiangsu Provincial Medical Youth Talent QNRC2016714Suzhou Health Leading Talent GSWS2019001
6 · The paper itself

Abstract

purposeThe study aims to investigate the absorption, metabolism, and excretion of donafenib, a deuterated derivative of sorafenib, in healthy Chinese male volunteers.

methodsSix healthy Chinese male volunteers were administered a single oral dose of 300 mg donafenib containing 120 µCi of [14 C]-donafenib. The study involved collecting and analyzing plasma, urine, and feces samples to determine the recovery and distribution of total radioactivity, identify metabolites, and assess the metabolic pathways of donafenib.

resultsThe mean recovery of total radioactivity was 97.31% of the administered dose. Six metabolites were identified, with the parent drug being the major radioactive component in plasma (67.52% of total radioactivity) and feces (83.17% of the dose). The N-oxidation metabolite (M2) was prominent in plasma. Donafenib was predominantly excreted via feces, indicating liver metabolism, with minimal renal excretion. The metabolic pathways of donafenib were similar to those of sorafenib, but the metabolite profiles differed significantly. Notably, the amide hydrolysis metabolite M6, present in sorafenib, was absent in donafenib.

conclusionDonafenib is primarily metabolized in the liver and excreted through feces, with a metabolic profile that differs from sorafenib due to the deuterium isotope effect. These differences in metabolic characteristics may contribute to donafenib's improved safety and efficacy as a treatment for advanced hepatocellular carcinoma (HCC).

Indexed as

Carbon RadioisotopesFecesAdministration, OralAdultAntineoplastic AgentsHealthy VolunteersHumansLiverMalePyridinesYoung AdultAntineoplastic AgentsCarbon-14Carbon RadioisotopesPyridines[14C]-donafenibDeuterium isotope effectMetabolismPharmacokineticsSorafenib

Identifiers

PMID39673613

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.