Evidence map›Paper›PMID 33749838›Full record

ArticleJournal of clinical pharmacology2021

Effects of Hepatic Impairment on the Pharmacokinetics of Abrocitinib and Its Metabolites.

Ellen Q Wang, Vu Le, Melissa O'Gorman, Sakambari Tripathy, Martin E Dowty, Lisy Wang, Bimal K Malhotra

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03626415 (A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN ADULT SUBJECTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT RELATIVE TO SUBJECTS WITH NORMAL HEPATIC FUNCTION), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT03626415 phase1completednot on this map

A phase 1, non-randomized, open-label, single-dose study to compare the pharmacokinetics, safety and tolerability of pf-04965842 in adult subjects with mild and moderate hepatic impairment relative to subjects with normal hepatic function

TypeinterventionalSponsorPfizerRan2018 to 2019Enrolled24ConditionsHepatic ImpairmentArmsPF-04965842
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. [Janus kinase inhibitors for skin disorders].Dermatologie (Heidelberg, Germany) · 2024
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  16. JAK-STAT pathway inhibitors in dermatology.Anais brasileiros de dermatologia
    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

7 authors at 1 institution in 1 country.

Ellen Q WangClinical Pharmacology, Global Product Development, Pfizer Inc., New York, New York, USA.
Vu LePfizer Inc., Groton, Connecticut, USA.
Melissa O'GormanGlobal Product Development, Pfizer Inc., Groton, Connecticut, USA.
Sakambari TripathyPfizer Inc., Groton, Connecticut, USA.
Martin E DowtyPharmacokinetics Dynamics and Metabolism, Medicine Design, Pfizer Inc., Cambridge, Massachusetts, USA.
Lisy WangClinical Development and Operation, Global Product Development, Pfizer Inc., Groton, Connecticut, USA.
Bimal K MalhotraClinical Pharmacology, Global Product Development, Pfizer Inc., New York, New York, USA.
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Abrocitinib, an oral once-daily Janus kinase 1 selective inhibitor, is under development for treatment of atopic dermatitis. This phase 1, nonrandomized, open-label, single-dose study (NCT03626415) investigated the effect of hepatic impairment on pharmacokinetics (PK), safety, and tolerability of abrocitinib and its metabolites after a 200-mg oral dose. Twenty-four subjects with varying degrees of hepatic function (normal, mild, and moderate impairment) were enrolled (N = 8/group). Active moiety PK parameters were calculated as the sum of unbound PK parameters for abrocitinib and its active metabolites. For abrocitinib, the ratios (percentages) of adjusted geometric means for area under the concentration-time curve from time 0 extrapolated to infinite time (AUC

Indexed as

AgedArea Under CurveBody Mass IndexFemaleHalf-LifeHumansJanus Kinase InhibitorsLiver FailureMaleMetabolic Clearance RateMiddle AgedPatient AcuityPyrimidinesSulfonamidesabrocitinibJanus Kinase InhibitorsPyrimidinesSulfonamidesabrocitinibactive moietyatopic dermatitishepatic impairmentpharmacokinetics

Identifiers

PMID33749838
PMCPMC8518898
OpenAlexW3137184272

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.