Evidence map›Paper›PMID 34431240›Full record

Trial reportClinical pharmacology in drug development2022

The Effect of Food on the Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan.

Darcy J Mulford, Eckhard Leifke, Mark Hibberd, Colin W Howden

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% 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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Vonoprazan and proton pump inhibitors: Which is superior forWorld journal of gastroenterology · 2025
    Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Vonoprazan: A New Potassium-Competitive Acid Blocker.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2023
    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

4 authors at 2 institutions in 1 country.

Darcy J MulfordResearch and Development, Phathom Pharmaceuticals, Buffalo Grove, Illinois, USA.
Eckhard LeifkeResearch and Development, Phathom Pharmaceuticals, Buffalo Grove, Illinois, USA.
Mark HibberdResearch and Development, Phathom Pharmaceuticals, Buffalo Grove, Illinois, USA.
Colin W HowdenDivision of Gastroenterology, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
Athenex (United States) · USUniversity of Tennessee Health Science Center · US

Funding

Takeda Global Research & Development Centre (Europe) Ltd
6 · The paper itself

Abstract

Herein, we report a food-effect study of vonoprazan, an oral potassium-competitive acid blocker. In a phase 1, randomized, open-label, crossover study, healthy subjects received a single 20-mg dose of vonoprazan either following an overnight fast or 30 minutes after a high-fat breakfast. Plasma vonoprazan levels were determined at 0 hour and at 17 subsequent assessment points up to 48 hours after dosing. After a 5-day washout, subjects received a second 20-mg vonoprazan dose in the alternative fed/fasted state (identical process repeated). Twenty-four subjects completed the study. Vonoprazan exposure was not meaningfully affected by food. Geometric mean ratios for maximum concentration, area under the concentration-time curve from time 0 to 24 hours, and area under the plasma concentration-time curve extrapolated to infinity obtained under fed and fasting conditions were 1.05 (90% confidence interval, 0.98-1.12), 1.13 (1.09-1.18), and 1.15 (1.11-1.19), respectively. Four subjects experienced 6 adverse events that were all mild and considered unrelated to the study drug. Vonoprazan can be administered without regard to food intake.

Indexed as

Food-Drug InteractionsPotassiumAdministration, OralCross-Over StudiesHumansPyrrolesSulfonamides1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanaminePotassiumPyrrolesSulfonamidesfood effectmetabolitespharmacodynamicspharmacokineticsvonoprazan

Identifiers

PMID34431240
PMCPMC9291755
OpenAlexW3195940931

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.