Evidence map›Paper›PMID 39602316›Full record

ArticleClinical and translational science2024

Deconvoluting zavegepant drug-drug interactions: A phase I study to evaluate the effects of rifampin and itraconazole on zavegepant pharmacokinetics.

Rajinder Bhardwaj, Jo Ann Malatesta, Jennifer Madonia, Matt S Anderson, Beth Morris, 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Trial
  2. Article
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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

9 authors.

Rajinder BhardwajCertara USA, Princeton, New Jersey, USA.ORCID 0009-0005-2720-2192
Jo Ann MalatestaCertara USA, Princeton, New Jersey, USA.
Jennifer MadoniaBiohaven Pharmaceuticals Inc., New Haven, Connecticut, USA.ORCID 0009-0000-8060-8478
Matt S AndersonCertara USA, Princeton, New Jersey, USA.ORCID 0009-0005-3940-7056
Beth MorrisBiohaven Pharmaceuticals Inc., New Haven, Connecticut, USA.ORCID 0009-0006-4347-2042
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 is a calcitonin gene-related peptide receptor antagonist for acute migraine treatment. This Phase I, open-label, fixed-sequence study evaluated the effects of itraconazole (a strong cytochrome P450 3A4 [CYP3A4] and P-glycoprotein [P-gp] inhibitor) on the pharmacokinetics of intranasal/oral zavegepant and the effects of rifampin (a strong inducer of CYP3A4 and P-gp; and an inhibitor of organic anion transporting polypeptide 1B3 [OATP1B3]) on oral zavegepant in healthy participants. In the intranasal/oral zavegepant-itraconazole cohort, participants received a single 10-mg dose of zavegepant nasal spray on Day 1, followed by oral zavegepant (50 mg) on Day 3. Itraconazole 200 mg once daily was administered from Days 4 to 12. On Day 7 zavegepant nasal spray and on Day 11 oral zavegepant were coadministered with itraconazole. In the oral zavegepant-rifampin cohort, participants received oral zavegepant (100 mg) on Day 1, rifampin 600 mg once daily on Days 2-10, and rifampin with zavegepant on Day 11. No significant change in zavegepant exposure was observed following coadministration of itraconazole with zavegepant nasal spray. For oral zavegepant coadministered with itraconazole, the area under the curve from 0 to infinity (AUC

Indexed as

Drug InteractionsItraconazoleRifampinAdministration, IntranasalAdministration, OralAdultArea Under CurveAzepinesCytochrome P-450 CYP3AFemaleHealthy VolunteersHumansMaleMiddle AgedSolute Carrier Organic Anion Transporter Family Member 1B3Young AdultAzepinesCYP3A4 protein, humanCytochrome P-450 CYP3AItraconazoleRifampinSLCO1B3 protein, humanSolute Carrier Organic Anion Transporter Family Member 1B3

Identifiers

PMID39602316
PMCPMC11601169

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Registered trials

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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.