Evidence map›Paper›PMID 28560658›Full record

Trial reportHepatology international2017

Safety, pharmacokinetics and pharmacogenetics of a single ascending dose of pradefovir, a novel liver-targeting, anti-hepatitis B virus drug, in healthy Chinese subjects.

Yanhua Ding, Hong Zhang, Xiaojiao Li, Cuiyun Li, Guiling Chen, Hong Chen, Min Wu, Junqi Niu

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Hepatology international, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Pradefovir Treatment in Patients With Chronic Hepatitis B: Week 24 Results From a Multicenter, Double-Blind, Randomized, Noninferiority, Phase 2 Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  2. Article
  3. HBV replication inhibitors.Antiviral research · 2020
    Review
  4. 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

8 authors.

Yanhua DingPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China.
Hong ZhangPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China.
Xiaojiao LiPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China.
Cuiyun LiPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China.
Guiling ChenPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China.
Hong ChenPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China.
Min WuPhase I Clinical Trial Unit, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China. wumin1987mary@126.com.
Junqi NiuDepartment of Hepatology, The First Hospital of Jilin University, Changchun, No. 71 Xinmin Street, Changchun, 130021, China. 15104458731@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPradefovir is efficiently converted to adefovir [9-(2-phosphonylmethoxyethyl) adenine (PMEA)], producing high hepatic PMEA concentration but low levels in the systemic circulation and kidney. The aim of this study is to evaluate the tolerability, adverse effect (AEs), pharmacokinetics and pharmacogenetics of a single ascending dose of pradefovir.

methodsFifty healthy subjects were divided into five groups and randomized within each group at a ratio of 3:1:1 to receive a single ascending dose of pradefovir (10, 30, 60, 90, or 120 mg), and 10 mg adefovir dipivoxil (ADP) or placebo. Blood and urine samples were collected and analyzed. A total of 1930 polymorphic loci were analyzed in 6 blood samples collected from the 90 mg pradefovir group.

resultsThe single oral dose of pradefovir up to 120 mg was well tolerated. A total of 29 dose-limited mild AEs were reported in 17 subjects. The peak plasma concentration (C

conclusionsThe single oral dose of pradefovir 10-120 mg was well tolerated. SNPs may be associated with variable rates of adverse events. TRIAL REGISTRATION NUMBER: CTR20140341.

Indexed as

Polymorphism, Single NucleotideAdenineAdultArylamine N-AcetyltransferaseCytochrome P-450 Enzyme SystemCytochrome P450 Family 2Drug Administration ScheduleFemaleHealthy VolunteersHumansIsoenzymesMaleOrganophosphorus CompoundsPharmacogenomic VariantsProdrugsYoung AdultAdenineArylamine N-AcetyltransferaseCYP2F1 protein, humanCytochrome P-450 Enzyme SystemCytochrome P450 Family 2IsoenzymesN-acetyltransferase 1Organophosphorus CompoundsPOR protein, humanpradefovirProdrugsHepatitis BPharmacogeneticsPharmacokineticsPradefovirSingle ascending doseTolerability

Identifiers

PMID28560658

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.