Evidence map›Paper›PMID 22664976›Full record

Trial reportAntimicrobial agents and chemotherapy2012

First-in-human study of the pharmacokinetics and antiviral activity of IDX375, a novel nonnucleoside hepatitis C virus polymerase inhibitor.

J de Bruijne, J van de Wetering de Rooij, A A van Vliet, X J Zhou, M F Temam, J Molles, J Chen, K Pietropaolo, J Z Sullivan-Bólyai, D Mayers and 1 more

Abstract readClinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. 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

11 authors.

J de BruijneAcademic Medical Center, Amsterdam, The Netherlands.
J van de Wetering de Rooij
A A van Vliet
X J Zhou
M F Temam
J Molles
J Chen
K Pietropaolo
J Z Sullivan-Bólyai
D Mayers
H W Reesink

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

IDX375 is a potent and selective palm-binding nonnucleoside inhibitor of the hepatitis C virus (HCV) genotype 1 polymerase. This first-in-human study evaluated the safety, tolerability, and pharmacokinetics of IDX375 in healthy volunteers, as well as its antiviral activity in HCV-infected patients. IDX375, as a choline salt, was administered for 1 day to 40 healthy male volunteers (25- to 200-mg IDX375-equivalent single ascending doses and a 200-mg twice-daily [BID] dose) and three patients chronically infected with HCV genotype 1 (200 mg BID only). IDX375 was well absorbed and well tolerated by all of the study participants. A single-day 200-mg BID dose resulted in exposure-related anti-HCV activity with maximal 0.5 to 1.1 log(10) reductions in plasma HCV RNA. These observations support further clinical investigations of IDX375.

Indexed as

AdultAntiviral AgentsEnzyme InhibitorsFemaleHepacivirusHepatitis CHumansLactamsMaleMiddle AgedOrganophosphorus CompoundsRNA-Dependent RNA PolymeraseRNA, ViralViral LoadAntiviral AgentsEnzyme InhibitorsIDX375LactamsOrganophosphorus CompoundsRNA-Dependent RNA PolymeraseRNA, Viral

Identifiers

PMID22664976
PMCPMC3421546

What OpenQuestion holds

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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.