Evidence map›Paper›PMID 42483482›Full record

Trial reportDrug design, development and therapy2026

The Effect of Food on the Pharmacokinetics and Gastrointestinal Tolerability of Bersiporocin, a Novel Oral Prolyl-tRNA-Synthetase Inhibitor.

Seungri Lee, YeaRa Kwak, Jiyeon Park, Yewon Park, Kyung-Sang Yu, Jaeseong Oh

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

6 authors.

Seungri Lee *Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.ORCID 0009-0005-9269-017X
YeaRa Kwak *Clinical Development Center, Daewoong Pharmaceutical Co., Ltd., Seoul, Republic of Korea.
Jiyeon ParkDrug Safety Monitoring Center, Seoul National University Hospital, Seoul, Republic of Korea.ORCID 0000-0003-1317-2891
Yewon ParkDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Kyung-Sang YuDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.ORCID 0000-0003-0921-7225
Jaeseong OhDepartment of Pharmacology, Jeju National University College of Medicine, Jeju, Republic of Korea.ORCID 0000-0001-6275-8587

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Bersiporocin is a first-in-class prolyl-tRNA-synthetase inhibitor under clinical development for the treatment of idiopathic pulmonary fibrosis. In a prior first-in-human study, the incidence of gastrointestinal (GI) adverse events (AEs) differed across prandial conditions. This study aimed to evaluate the effect of food on the pharmacokinetics (PKs) and safety profile of bersiporocin. Patients and Methods: This randomized, open-label, single-dose, three-period crossover study enrolled 36 healthy Korean participants. Each participant received a single oral dose of bersiporocin 200 mg under three conditions: fasted (A), 30 minutes after a high-fat meal (B), and 2 hours after a high-fat meal (C), with a 7-day washout between periods. Plasma concentrations of bersiporocin and its active metabolite M8 were quantified using a validated LC-MS/MS assay, and PK parameters were determined by non-compartmental analysis. Safety was evaluated by monitoring AEs, clinical laboratory tests, vital signs, and electrocardiograms. Results: A high-fat meal delayed the absorption of bersiporocin and M8. The median T Conclusion: A high-fat meal delayed the oral absorption rate of bersiporocin but did not have a clinically significant effect on systemic exposure to bersiporocin or M8. Given the increased incidence of GI AEs under early postprandial conditions, administration under fasted conditions or at least 2 hours postprandially may be appropriate for future clinical studies.

Indexed as

Amino Acyl-tRNA SynthetasesEnzyme InhibitorsFood-Drug InteractionsGastrointestinal TractAdministration, OralAdultCross-Over StudiesFemaleHumansMaleMiddle AgedYoung AdultAmino Acyl-tRNA SynthetasesEnzyme Inhibitorsprolyl T RNA synthetase3-period crossover studybioavailabilityenteric-coated formulationidiopathic pulmonary fibrosis

Identifiers

PMID42483482
PMCPMC13387375

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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.