ArticleAdvances in therapy2025
Phase I Study to Evaluate the Effect of Hepatic Impairment on Pharmacokinetics and Safety of Tegoprazan, a Potassium Competitive Acid Blocker.
Article in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04494269 (An Open-label, Multi-center, Single-dose, Parallel-group Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls), which is not on this map. Cited by 1 paper.
What it found
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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.
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.
An Open-label, Multi-center, Single-dose, Parallel-group Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
Who cites it
1 citing paper in PubMed.
- Efficacy and Tolerability of Tegoprazan Compared to Proton Pump Inhibitors in the Treatment of Erosive Esophagitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTegoprazan is a potassium-competitive acid blocker, and its systemic exposure is presumably affected by hepatic clearance and bioavailability. This study aimed to investigate the effect of hepatic impairment (HI) on the safety and pharmacokinetics of tegoprazan and metabolite.
methodsAn open-label, multicenter, parallel-group study was conducted in patients with mild (n = 8), moderate (n = 8) and severe (n = 1) HI according to the Child-Pugh classification as well as controls. Healthy subjects (n = 8) were matched to patients with the moderate category based on age, body mass index and sex. Blood and urine samples were obtained to evaluate the concentrations of tegoprazan and metabolite (M1) until 48 h after a single oral administration of 50 mg of tegoprazan.
resultsThe geometric mean ratio with a 90% confidence interval of maximum plasma concentration and area under the plasma concentration-time curve for tegoprazan in patients with impaired hepatic function compared to controls were 0.8228 (0.4997-1.3550) and 1.2264 (0.7447-2.0197) in the mild category, 1.0332 (0.6274-1.7015) and 1.7676 (1.0733-2.9109) in the moderate category, and 1.0699 (0.3713-3.0823) and 1.9567 (0.6792-5.6377) in the severe category. The half-life, apparent clearance, renal clearance, and fraction unbound to plasma protein were comparable across study groups. The plasma concentration of M1 increased and decreased faster in the normal group. Tegoprazan was generally well tolerated in patients with HI.
conclusionsSystemic exposure to tegoprazan tended to be increased in subjects with HI. The difference between patients with mild HI and the controls was deemed not to require dose adjustment for tegoprazan. CLINICAL
trial registrationClinicalTrials.gov identifiers: NCT04494269 (31 Jul 2020).
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Registered trials
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