Evidence map›Paper›PMID 32945596›Full record

ArticlePharmacology research & perspectives2020

Ibrutinib does not have clinically relevant interactions with oral contraceptives or substrates of CYP3A and CYP2B6.

Jan de Jong, Anna Mitselos, Wojciech Jurczak, Raul Cordoba, Carlos Panizo, Tomasz Wrobel, Monika Dlugosz-Danecka, James Jiao, Juthamas Sukbuntherng, Daniele Ouellet and 1 more

Open access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Pharmacology research & perspectives, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 50% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. 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

11 authors at 8 institutions in 5 countries.

Jan de JongClinical Pharmacology, Janssen Research & Development LLC, San Diego, CA, USA.
Anna MitselosClinical Research Oncology, Janssen Research & Development LLC, Beerse, Belgium.
Wojciech JurczakMaria Sklodowska-Curie National Institute of Oncology, Krakow, Poland.
Raul CordobaLymphoma Unit, Department of Hematology, Fundacion Jimenez Diaz University Hospital, Madrid, Spain.
Carlos PanizoDepartment of Hematology, Clínica Universidad de Navarra, Pamplona, Spain.
Tomasz WrobelDepartment and Clinic of Hematology, Blood Neoplasms, and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland.
Monika Dlugosz-DaneckaMaria Sklodowska-Curie National Institute of Oncology, Krakow, Poland.
James JiaoClinical Pharmacology, Janssen Research & Development LLC, Raritan, NJ, USA.
Juthamas SukbuntherngPharmacyclics LLC, an AbbVie company, Sunnyvale, CA, USA.
Daniele OuelletClinical Pharmacology, Janssen Research & Development LLC, Spring House, PA, USA.
Peter HellemansClinical Research Oncology, Janssen Research & Development LLC, Beerse, Belgium.
Janssen (Belgium) · BENational Institute of Oncology · HUAbbVie (United States) · USClinica Universidad de Navarra · ESJanssen (United States) · USMadrid Health Service · ESSpringhouse · USWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ibrutinib may inhibit intestinal CYP3A4 and induce CYP2B6 and/or CYP3A. Secondary to potential induction, ibrutinib may reduce the exposure and effectiveness of oral contraceptives (OCs). This phase I study evaluated the effect of ibrutinib on the pharmacokinetics of the CYP2B6 substrate bupropion, CYP3A substrate midazolam, and OCs ethinylestradiol (EE) and levonorgestrel (LN). Female patients (N = 22) with B-cell malignancies received single doses of EE/LN (30/150 μg) and bupropion/midazolam (75/2 mg) during a pretreatment phase on days 1 and 3, respectively (before starting ibrutinib on day 8), and again after ibrutinib 560 mg/day for ≥ 2 weeks. Intestinal CYP3A inhibition was assessed on day 8 (single-dose ibrutinib plus single-dose midazolam). Systemic induction was assessed at steady-state on days 22 (EE/LN plus ibrutinib) and 24 (bupropion/midazolam plus ibrutinib). The geometric mean ratios (GMRs; test/reference) for maximum plasma concentration (C

Indexed as

AdenineAdministration, OralAdultAgedAged, 80 and overArea Under CurveBupropionContraceptives, OralCytochrome P-450 CYP2B6Cytochrome P-450 CYP3ADrug InteractionsEthinyl EstradiolFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellLevonorgestrelAdenineBupropionContraceptives, OralCYP2B6 protein, humanCYP3A protein, humanCytochrome P-450 CYP2B6Cytochrome P-450 CYP3AEthinyl EstradiolibrutinibLevonorgestrelMidazolamPiperidinesCytochrome P450drug interactionspharmacokineticsphase I

Identifiers

PMID32945596
PMCPMC7506988
OpenAlexW3087288410

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.