Evidence map›Paper›PMID 33356019›Full record

ArticleClinical pharmacology in drug development2021

Pharmacokinetics and Safety of Glasdegib in Participants With Moderate/Severe Hepatic Impairment: A Phase I, Single-Dose, Matched Case-Control Study.

Joanna C Masters, Robert R LaBadie, Joanne Salageanu, Jerry Li, Naveed Shaik

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical pharmacology in drug development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03627754 (A PHASE 1, OPEN LABEL, SINGLE DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS OF GLASDEGIB), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 42% 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.

NCT03627754 phase1completednot on this map

A phase 1, open label, single dose, parallel group study to evaluate the plasma pharmacokinetics of glasdegib (pf-04449913) in healthy subjects with normal hepatic function and in subjects with impaired hepatic function

TypeinterventionalSponsorPfizerRan2018 to 2019Enrolled24ConditionsHepatic ImpairmentArmsGlasdegib 100 mg single oral dose
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. 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

5 authors at 1 institution in 1 country.

Joanna C MastersPharmacometrics, Pfizer Inc, La Jolla, California, USA.
Robert R LaBadieClinical Statistics, Pfizer Inc, Groton, Connecticut, USA.
Joanne SalageanuPharmacometrics, Pfizer Inc, Groton, Connecticut, USA.
Jerry LiClinical Pharmacology, Pfizer Inc, La Jolla, California, USA.
Naveed ShaikClinical Pharmacology, Pfizer Inc, La Jolla, California, USA.
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase I open-label trial (NCT03627754) assessed glasdegib pharmacokinetics and safety in otherwise healthy participants with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Participants with hepatic impairment and age/weight-matched controls with normal hepatic function received a single oral 100-mg glasdegib dose under fasted conditions. The primary end points were area under the plasma concentration-time curve from time zero to infinity (AUC

Indexed as

AgedAntineoplastic AgentsArea Under CurveBenzimidazolesCase-Control StudiesFastingFemaleHumansLiver DiseasesMaleMiddle AgedPhenylurea CompoundsSeverity of Illness IndexAntineoplastic AgentsBenzimidazolesglasdegibPhenylurea Compoundsacute myeloid leukemiaglasdegibhepaticoncologypharmacokinetics

Identifiers

PMID33356019
PMCPMC8359308
OpenAlexW3115244952

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.