Evidence map›Paper›PMID 26111126›Full record

ArticleClinical and translational gastroenterology2015

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising TAK-438 (Vonoprazan) Doses in Healthy Male Japanese/non-Japanese Subjects.

Yuuichi Sakurai, Akira Nishimura, Gale Kennedy, Mark Hibberd, Richard Jenkins, Hiroyuki Okamoto, Tomoki Yoneyama, Helen Jenkins, Kiyoshi Ashida, Shin Irie and 1 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical and translational gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06318104 (Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days), which is not on this map. Cited by 91 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 5 pooled it
12.5field-weighted citation impact, top 1% 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.

NCT06318104 phase4unknown statusnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days

TypeinterventionalSponsorHospital General de México Dr. Eduardo LiceagaRan2024 to 2025Enrolled160ConditionsHelicobacter Pylori InfectionArmsTegoprazan, Esomeprazole 40mg
3 · Its place in the literature

Who cites it

91 citing papers in PubMed, 5 syntheses or guidelines pooled it, 189 citations in OpenAlex.

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31 more citing papers are in PubMed but not listed here.

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 5 institutions in 2 countries.

Yuuichi SakuraiTakeda Pharmaceutical Company Ltd, Osaka, Japan.
Akira NishimuraTakeda Pharmaceutical Company Ltd, Osaka, Japan.
Gale KennedyTakeda Development Centre Europe Ltd, London, UK.
Mark HibberdTakeda Development Centre Europe Ltd, London, UK.
Richard JenkinsTakeda Development Centre Europe Ltd, London, UK.
Hiroyuki OkamotoTakeda Pharmaceutical Company Ltd, Osaka, Japan.
Tomoki YoneyamaTakeda Pharmaceutical Company Ltd, Fujisawa, Japan.
Helen JenkinsTakeda Development Centre Europe Ltd, London, UK.
Kiyoshi AshidaDepartment of Gastroenterology and Hepatology, Saiseikai Nakatsu Hospital, Osaka, Japan.
Shin IrieMedical Co. LTA Honjo Clinic (current Sumida Hospital), Tokyo, Japan.
Jörg Täubel1] Richmond Pharmacology Ltd, London, UK [2] St George's University of London, London, UK.
Takeda (Japan) · JPTakeda (United Kingdom) · GBOida Hospital · JPSaiseikai Nakatsu Hospital · JPSt George's, University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-438 (vonoprazan, a potassium-competitive acid blocker) in healthy male subjects.

methodsIn two phase I, randomized, double-blind, placebo-controlled, single rising-dose studies, healthy male subjects (Japan N=84; UK N=63) received a single TAK-438 dose (1-120 mg in Japan and 1-40 mg in the UK). Assessments included safety, tolerability, pharmacokinetics, and pharmacodynamics (intragastric pH).

resultsPlasma concentration-time profiles of TAK-438 at all dose levels showed rapid absorption (median Tmax up to 2 h). Estimated mean elimination half-life was up to 9 h. Exposure was slightly greater than dose proportional. No clear difference in TAK-438 pharmacokinetics was observed between Japanese and non-Japanese subjects. Acid suppression was dose dependent and similar in both studies. The 24-h intragastric pH ≥4 holding time ratio with 40 mg TAK-438 was 92% in Japan and 87% in the UK. TAK-438 was well tolerated, with no adverse events reported in Japanese subjects; 10 of 63 UK subjects experienced 12 treatment-emergent adverse events (non-serious). Increases in serum gastrin and pepsinogen I and II concentrations were observed at doses ≥10 mg, but there were no changes in alanine aminotransferase concentrations.

conclusionsSingle oral doses of TAK-438 20-120 mg caused rapid, profound, and 24-h suppression of gastric acid secretion in healthy male subjects, regardless of geographical region, and TAK-438 was well tolerated at all doses studied, making it a potential alternative to proton pump inhibitors for the treatment of acid-related disorders.

Identifiers

PMID26111126
PMCPMC4816246
OpenAlexW1537289008

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Registered trials

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.