Evidence map›Paper›PMID 36029150›Full record

ArticleClinical pharmacology in drug development2022

Bioequivalence and Relative Bioavailability Studies to Assess a New Acalabrutinib Formulation That Enables Coadministration With Proton-Pump Inhibitors.

Shringi Sharma, Xavier Pepin, Harini Burri, Lianqing Zheng, Nataliya Kuptsova-Clarkson, Anouk de Jong, Ting Yu, Holly L MacArthur, Michal Majewski, John C Byrd and 7 more

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In one paragraph

Article in Clinical pharmacology in drug development, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

11 citing papers in PubMed, 26 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

17 authors at 5 institutions in 3 countries.

Shringi SharmaAstraZeneca, South San Francisco, California, USA.
Xavier PepinNew Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, England, UK.
Harini BurriAstraZeneca, South San Francisco, California, USA.
Lianqing ZhengAstraZeneca, South San Francisco, California, USA.
Nataliya Kuptsova-ClarksonAstraZeneca, Gaithersburg, Maryland, USA.
Anouk de JongAcerta Pharma B.V., Oss, The Netherlands.
Ting YuAstraZeneca, South San Francisco, California, USA.
Holly L MacArthurAstraZeneca, Mississauga, Ontario, Canada.
Michal MajewskiAstraZeneca, Mississauga, Ontario, Canada.
John C ByrdDepartment of Internal Medicine and University of Cincinnati Cancer Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Richard R FurmanNew York-Presbyterian/Weill Cornell Medicine, New York, New York, USA.
Joseph A WareAstraZeneca, South San Francisco, California, USA.
James MannOral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, England, UK.
David RamiesAstraZeneca, South San Francisco, California, USA.
Veerendra MunugalavadlaAstraZeneca, South San Francisco, California, USA.
Louise SheridanPharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, England, UK.
Helen TomkinsonAstraZeneca, Cambridge, England, UK.
AstraZeneca (United States) · USAstraZeneca (United Kingdom) · GBAstraZeneca (Canada) · CAPresbyterian Hospital · USUniversity of Cincinnati Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acalabrutinib is a Bruton tyrosine kinase (BTK) inhibitor approved to treat adults with chronic lymphocytic leukemia, small lymphocytic lymphoma, or previously treated mantle cell lymphoma. As the bioavailability of the acalabrutinib capsule (AC) depends on gastric pH for solubility and is impaired by acid-suppressing therapies, coadministration with proton-pump inhibitors (PPIs) is not recommended. Three studies in healthy subjects (N = 30, N = 66, N = 20) evaluated the pharmacokinetics (PKs), pharmacodynamics (PDs), safety, and tolerability of acalabrutinib maleate tablet (AT) formulated with pH-independent release. Subjects were administered AT or AC (orally, fasted state), AT in a fed state, or AT in the presence of a PPI, and AT or AC via nasogastric (NG) route. Acalabrutinib exposures (geometric mean [% coefficient of variation, CV]) were comparable for AT versus AC (AUC

Indexed as

Proton Pump InhibitorsPyrazinesAdultBenzamidesBiological AvailabilityHumansProtein Kinase InhibitorsTabletsTherapeutic EquivalencyacalabrutinibBenzamidesProtein Kinase InhibitorsProton Pump InhibitorsPyrazinesTabletsacalabrutinib capsuleacalabrutinib tabletbioequivalencefood effectproton-pump inhibitorrelative bioavailability

Identifiers

PMID36029150
OpenAlexW4293367557

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.