Evidence map›Paper›PMID 29672897›Full record

Trial reportBritish journal of clinical pharmacology2018

Evaluation of a Janus kinase 1 inhibitor, PF-04965842, in healthy subjects: A phase 1, randomized, placebo-controlled, dose-escalation study.

Elena Peeva, Martin R Hodge, Elizabeth Kieras, Michael L Vazquez, Kosalaram Goteti, Sanela G Tarabar, Christine W Alvey, Christopher Banfield

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IRandomized 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. It is linked to trial NCT01835197 (A Phase 1, Within Cohort, Randomized, Double Blind, Third-Party Open, Placebo-Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-04965842 In Healthy Western and Japanese Subjects), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
1.7field-weighted citation impact, top 18% 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.

NCT01835197 phase1completednot on this map

A Phase 1, Within Cohort, Randomized, Double Blind, Third-Party Open, Placebo-Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-04965842 In Healthy Western and Japanese Subjects

TypeinterventionalSponsorPfizerRan2013 to 2014Enrolled79ConditionsHealthyArmsPF-04965842, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 45 citations in OpenAlex.

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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 1 institution in 1 country.

Elena PeevaPfizer, Cambridge, MA, USA.
Martin R HodgePfizer, Cambridge, MA, USA.
Elizabeth KierasPfizer, Cambridge, MA, USA.
Michael L VazquezPfizer, Cambridge, MA, USA.
Kosalaram GotetiPfizer, Cambridge, MA, USA.
Sanela G TarabarPfizer, New Haven, CT, USA.
Christine W AlveyPfizer, Groton, CT, USA.
Christopher BanfieldPfizer, Cambridge, MA, USA.
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo determine the safety, tolerability, pharmacokinetics and pharmacodynamics of the Janus kinase 1-selective inhibitor, PF-04965842.

methodsThis was a phase 1, first-in-human, randomized, double-blind, placebo-controlled, combination single- and multiple-dose escalation, parallel design study in healthy subjects (http://clinicaltrials.gov, NCT01835197). Subjects received a single dose of placebo or 3, 10, 30, 100, 200, 400 or 800 mg PF-04965842 (single ascending dose phase) and placebo or 30 mg once daily (QD), 100 mg QD, 200 mg QD, 400 mg QD, 100 mg twice daily (BID) or 200 mg BID PF-04965842 for 10 consecutive days (multiple ascending dose phase). The primary objective was to determine the safety and tolerability of PF-04965842.

resultsSeventy-nine subjects were randomized and received study treatments. There were no deaths or serious adverse events. The most frequent treatment-emergent adverse events were headache (n = 13), diarrhoea (n = 11) and nausea (n = 11). PF-04965842 was absorbed rapidly (median time at which maximum plasma concentration occurred generally ≤1 h following either single- or multiple-dose administration) and eliminated rapidly (mean t

conclusionsThese results support further evaluation of PF-04965842 for clinical use in patients with inflammatory diseases.

Indexed as

AdultArea Under CurveDiarrheaDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHeadacheHumansJanus Kinase 1MaleMiddle AgedNauseaProtein Kinase InhibitorsPyrimidinesSulfonamidesabrocitinibJAK1 protein, humanJanus Kinase 1Protein Kinase InhibitorsPyrimidinesSulfonamidesinflammatory diseasesJAK1 inhibitorPF-04965842pharmacodynamicspharmacokineticsphase 1

Identifiers

PMID29672897
PMCPMC6046510
OpenAlexW2802473577

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Registered trials

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.