Evidence map›Paper›PMID 37060187›Full record

ArticleClinical and translational science2023

Rilzabrutinib, a reversible covalent Bruton's tyrosine kinase inhibitor: Absorption, metabolism, excretion, and absolute bioavailability in healthy participants.

Sibel Ucpinar, Patrick F Smith, Li Long, Fujun Li, Hui Yan, Jyoti Wadhwa, Katherine A Chu, Jin Shu, Philip Nunn, Mengyao Li

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.7field-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

10 citing papers in PubMed, 13 citations in OpenAlex.

  1. Emerging Therapies for Anaphylaxis.Immunology and allergy clinics of North America · 2026
    Review
  2. Review
  3. Review
  4. Review
  5. Current and future landscape of Bruton tyrosine kinase inhibitors in allergy.The Journal of allergy and clinical immunology · 2025
    Review
  6. Review
  7. Bruton's tyrosine kinase inhibition for the treatment of allergic disorders.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2024
    Review
  8. Review
  9. Article
  10. 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

10 authors at 4 institutions in 1 country.

Sibel UcpinarDepartment of Pharmacokinetics, Dynamics, and Metabolism, Sanofi US, Inc., Bridgewater, New Jersey, USA.
Patrick F SmithIntegrated Drug Development, Certara, Parsippany, New Jersey, USA.
Li LongClinical and Pharmaceutical Development, Kezar Life Sciences, South San Francisco, California, USA.
Fujun LiAnalytical and Pharmaceutical Development, Sanofi US, Inc., Bridgewater, New Jersey, USA.
Hui YanAnalytical and Pharmaceutical Development, Sanofi US, Inc., Bridgewater, New Jersey, USA.
Jyoti WadhwaClinical and Pharmaceutical Development, Kezar Life Sciences, South San Francisco, California, USA.
Katherine A ChuAnalytical and Pharmaceutical Development, Sanofi US, Inc., Bridgewater, New Jersey, USA.
Jin ShuPrincipia Biopharma Inc., South San Francisco, California, USA.
Philip NunnPrincipia Biopharma Inc., South San Francisco, California, USA.
Mengyao LiDepartment of Pharmacokinetics, Dynamics, and Metabolism, Sanofi US, Inc., Bridgewater, New Jersey, USA.
Sanofi (United States) · USEnzo Life Sciences (United States) · USPrincipia Biopharma (United States) · USCertara (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This single-center, open-label, non-randomized, two-part, phase I study was conducted (1) to evaluate the absolute oral bioavailability of rilzabrutinib 400 mg tablet following an i.v. microtracer dose of ~100 μg [14C]-rilzabrutinib (~1 μCi) and single oral dose of 400 mg rilzabrutinib tablet (part 1), and (2) to characterize the absorption, metabolism, and excretion (AME) of 14C-radiolabeled rilzabrutinib following single oral dose (300 mg) of [14C]-rilzabrutinib (~1000 μCi; administered as a liquid) in healthy male participants (part 2). A total of 18 subjects were enrolled (n = 8 in part 1; n = 10 in part 2). The absolute bioavailability of 400 mg rilzabrutinib oral tablet was low (<5%). In part 1, rilzabrutinib was absorbed rapidly after single oral dose of rilzabrutinib 400 mg tablet with a median (range) time to maximum concentration (T

Indexed as

Protein Kinase InhibitorsTyrosine Kinase InhibitorsAdministration, OralBiological AvailabilityCarbon RadioisotopesHealthy VolunteersHumansMaleCarbon-14Carbon RadioisotopesProtein Kinase InhibitorsTyrosine Kinase Inhibitors

Identifiers

PMID37060187
PMCPMC10339699
OpenAlexW4365810285

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.