Evidence map›Paper›PMID 27717999›Full record

Trial reportEuropean journal of clinical pharmacology2017

Effect of bosutinib on the absorption of dabigatran etexilate mesylate, a P-glycoprotein substrate, in healthy subjects.

Poe-Hirr Hsyu, Daniela Soriano Pignataro, Kyle Matschke

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02102633 (An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Bosutinib On The Pharmacokinetics Of Dabigatran Etexilate Mesylate Administered Orally To Healthy Subjects), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 13% 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.

NCT02102633 phase1completednot on this map

An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Oral Dose Of Bosutinib On The Pharmacokinetics Of Dabigatran Etexilate Mesylate Administered Orally To Healthy Subjects

TypeinterventionalSponsorPfizerRan2014 to 2014Enrolled27ConditionsHealthyArmsDabigatran, Bosutinib
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
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

3 authors at 2 institutions in 2 countries.

Poe-Hirr HsyuPfizer Inc, 10646 Science Center Drive, La Jolla, CA, 92121, USA. Poe-Hirr.Hysu@pfizer.com.
Daniela Soriano PignataroPfizer Inc, Walton Oaks, Dorking Road, Surrey, KT20 7NS, UK.
Kyle MatschkePfizer Inc, 500 Arcola Road, Collegeville, PA, 19426, USA.
Pfizer (United States) · USPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeBosutinib, a dual Src and Abl tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia, demonstrated concentration-dependent inhibitory effects on P-glycoprotein (P-gp)-mediated digoxin efflux in vitro, suggesting that bosutinib may inhibit P-gp substrates. The effect of bosutinib on dabigatran etexilate mesylate (EM) absorption, a P-gp substrate, was evaluated.

methodsIn this open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study, healthy, fed subjects received dabigatran EM (150 mg × 1 orally) alone or 1 h after receiving bosutinib tablets (100 mg × 5 orally).

resultsDabigatran EM monotherapy and concurrent administration of dabigatran EM with bosutinib resulted in similar values for concentration time curves from time zero extrapolated to infinity (AUC

conclusionThese data demonstrate that single doses of bosutinib do not affect dabigatran exposure, suggesting that bosutinib is not a clinical inhibitor of P-gp.

trial registrationClinicalTrials.gov NCT02102633. https://clinicaltrials.gov/ct2/show/NCT02102633?term=NCT02102633&rank=1.

Indexed as

AdultAniline CompoundsAntineoplastic AgentsAntithrombinsArea Under CurveATP Binding Cassette Transporter, Subfamily B, Member 1Cross-Over StudiesDabigatranDrug InteractionsFemaleHealthy VolunteersHumansIntestinal AbsorptionMaleMiddle AgedNitrilesAniline CompoundsAntineoplastic AgentsAntithrombinsATP Binding Cassette Transporter, Subfamily B, Member 1bosutinibDabigatranNitrilesProtein Kinase InhibitorsQuinolinesAprepitantBosutinibDabigatranDrug–drug interactionsPharmacokineticsTyrosine kinase inhibitor

Identifiers

PMID27717999
OpenAlexW2528635914

What OpenQuestion holds

Textmetadata
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.