Evidence map›Paper›PMID 39014555›Full record

ArticleClinical and translational science2024

Reduced hepatic impairment study to evaluate pharmacokinetics and safety of zavegepant and to inform dosing recommendation for hepatic impairment.

Rajinder Bhardwaj, Mary K Donohue, Jennifer Madonia, Beth Morris, Thomas C Marbury, Kyle T Matschke, Robert Croop, Richard Bertz, Jing Liu

Abstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Clinical evaluation of zavegepant for the acute treatment of migraine.Journal of managed care & specialty pharmacy · 2025
    Review
  7. Article
  8. 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

9 authors.

Rajinder BhardwajCertara USA, Princeton, New Jersey, USA.ORCID 0009-0005-2720-2192
Mary K DonohueBiohaven Pharmaceuticals, Inc., New Haven, Connecticut, USA.ORCID 0009-0006-0450-5702
Jennifer MadoniaBiohaven Pharmaceuticals, Inc., New Haven, Connecticut, USA.ORCID 0009-0000-8060-8478
Beth MorrisBiohaven Pharmaceuticals, Inc., New Haven, Connecticut, USA.ORCID 0009-0006-4347-2042
Thomas C MarburyOrlando Clinical Research Center, Orlando, Florida, USA.ORCID 0000-0002-6416-3314
Kyle T MatschkePfizer Inc., Collegeville, Pennsylvania, USA.ORCID 0009-0003-2043-851X
Robert CroopBiohaven Pharmaceuticals, Inc., New Haven, Connecticut, USA.ORCID 0009-0004-0151-1192
Richard BertzBiohaven Pharmaceuticals, Inc., New Haven, Connecticut, USA.ORCID 0009-0006-4593-1310
Jing LiuPfizer Inc., Groton, Connecticut, USA.ORCID 0000-0001-9481-5961

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Zavegepant, a high-affinity, selective, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist, is approved in the United States for acute treatment of migraine in adults. The effects of moderate hepatic impairment (8 participants with Child-Pugh score 7-9 points) on the pharmacokinetics of a single 10-mg intranasal dose of zavegepant versus eight matched participants with normal hepatic function were evaluated in a phase I study. Pharmacokinetic sampling determined total and unbound plasma zavegepant concentrations. Moderate hepatic impairment increased the exposure of total zavegepant (~2-fold increase in AUC

Indexed as

Calcitonin Gene-Related Peptide Receptor AntagonistsAdministration, IntranasalAdultAgedArea Under CurveAzepinesFemaleHumansLiverLiver DiseasesMaleMiddle AgedMigraine DisordersAzepinesCalcitonin Gene-Related Peptide Receptor Antagonists

Identifiers

PMID39014555
PMCPMC11252018

What Socratic 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 Socratic graph.