Evidence map›Paper›PMID 30098042›Full record

Trial reportBritish journal of clinical pharmacology2018

Single- and multiple-dose pharmacokinetics and safety of pimodivir, a novel, non-nucleoside polymerase basic protein 2 subunit inhibitor of the influenza A virus polymerase complex, and interaction with oseltamivir: a Phase 1 open-label study in healthy volunteers.

Sofie Deleu, Thomas N Kakuda, Kurt Spittaels, Jurgen J Vercauteren, Vera Hillewaert, Amy Lwin, Lorant Leopold, Richard M W Hoetelmans

Open access · bronzeAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

10 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
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  10. Influenza virus polymerase inhibitors in clinical development.Current opinion in infectious diseases · 2019
    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 at 2 institutions in 2 countries.

Sofie DeleuJanssen Research & Development, Beerse, Belgium.
Thomas N KakudaAlios BioPharma, Inc., South San Francisco, CA, USA; at the time of study, Janssen Research & Development LLC, Titusville, NJ, USA.ORCID 0000-0001-6857-2572
Kurt SpittaelsJanssen Infectious Diseases, Beerse, Belgium.
Jurgen J VercauterenJanssen Research & Development, Beerse, Belgium.
Vera HillewaertJanssen Research & Development, Beerse, Belgium.
Amy LwinJanssen Research & Development, Rockville, MD, USA.
Lorant LeopoldJanssen Research & Development LLC, Titusville, NJ, USA.
Richard M W HoetelmansJanssen Infectious Diseases, Beerse, Belgium.
Janssen (Belgium) · BEJanssen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study was to evaluate the drug-drug interaction between pimodivir, a novel, non-nucleoside polymerase basic protein 2 (PB2) subunit inhibitor of the influenza A virus polymerase complex, and oseltamivir, to assess the feasibility of this combination therapy. Furthermore, single- and multiple-dose pharmacokinetics and safety of pimodivir in healthy volunteers were assessed.

methodsIn Part 1 of this open-label Phase 1 study, healthy volunteers (n = 18) were randomized to one of six cross-over treatment sequences, each comprising administration of oseltamivir 75 mg or pimodivir 600 mg or combination thereof twice daily on Days 1-4, followed by a single morning dose on Day 5. Between each treatment session, there was a minimum 5-day washout period. In Part 2, healthy volunteers (n = 16) randomly received pimodivir 600 mg or placebo (3:1) twice daily on Days 1-9, followed by a single morning dose on Day 10. Pharmacokinetics of pimodivir, oseltamivir and oseltamivir carboxylate, and safety were assessed.

resultsIn Part 1, co-administration of pimodivir with oseltamivir increased the C

conclusionCombination treatment with pimodivir and oseltamivir in healthy volunteers showed no clinically relevant drug-drug interactions. No safety concerns were identified with pimodivir 600 mg twice daily alone or in combination with oseltamivir 75 mg twice daily.

Indexed as

AdolescentAdultAntiviral AgentsArea Under CurveCross-Over StudiesDiarrheaDouble-Blind MethodDrug InteractionsFemaleHumansMaleMiddle AgedOseltamivirPyridinesPyrimidinesPyrrolesAntiviral AgentsOseltamiviroseltamivir carboxylatepimodivirPyridinesPyrimidinesPyrrolescombinationdrug-drug interactionoseltamivirpharmacokineticspimodivirsafety

Identifiers

PMID30098042
PMCPMC6177716
OpenAlexW2885522167

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.