Evidence map›Paper›PMID 40676451›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2025

Assessing the Effect of Food on the Pharmacokinetics of Iclepertin in Healthy Volunteers: A Phase I, Open-Label, Randomised, Cross-over Trial.

Shilpa Madari, Kerstin Breithaupt-Groegler, Brett A English, Kathrin Hohl, Arvid Jungnik, Michael Desch

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05347004 (The Effect of Food on the Pharmacokinetics of a BI 425809 Tablet Formulation Administered as a Single Dose With and Without Food to Healthy Subjects), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05347004 phase1completednot on this map

The Effect of Food on the Pharmacokinetics of a BI 425809 Tablet Formulation Administered as a Single Dose With and Without Food to Healthy Subjects (an Open-label, Randomised, Two-period, Two-sequence Crossover Trial)

TypeinterventionalSponsorBoehringer IngelheimRan2022 to 2022Enrolled16ConditionsHealthyArmsBI 425809
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Shilpa MadariBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Kerstin Breithaupt-GroeglerBoehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, 88400, Biberach an der Riss, Germany.
Brett A EnglishBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Kathrin HohlBoehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, 88400, Biberach an der Riss, Germany.
Arvid JungnikBoehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, 88400, Biberach an der Riss, Germany.
Michael DeschBoehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Strasse 65, 88400, Biberach an der Riss, Germany. michael.desch@boehringer-ingelheim.com.ORCID http://orcid.org/0000-0003-0205-1592

Funding

Boehringer Ingelheim 1346-0053
6 · The paper itself

Abstract

BACKGROUND AND

objectivesIclepertin, a selective glycine transporter-1 inhibitor, was investigated as a potential treatment for cognitive impairment associated with schizophrenia. The objective of this trial was to determine the effect of food on the pharmacokinetics of iclepertin 10 mg.

methodsThis Phase I, open-label, 2-period cross-over trial randomised (1:1) healthy volunteers to 2 treatment sequences (fasted-fed or fed-fasted) to receive a single oral dose of iclepertin 10 mg once daily in either the fasted or fed state followed by cross-over to the other state. Primary endpoints included maximum measured concentration in plasma (C

resultsOf 16 participants enrolled [mean (SD) age: 37.1 (10.1) years], 15 were included in the analysis. The C

conclusionIclepertin exposure was higher in fed versus fasted conditions, but the increase was minor, suggesting food has no meaningful effect on the pharmacokinetics of iclepertin 10 mg. STUDY REGISTRATION: ClinicalTrials.gov (NCT05347004; registered: 20 April 2022).

Indexed as

Food-Drug InteractionsPiperazinesAdministration, OralAdultArea Under CurveBiological AvailabilityCross-Over StudiesFastingFemaleGlycine Plasma Membrane Transport ProteinsHealthy VolunteersHumansMaleMiddle AgedSulfonesYoung Adult(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanoneGlycine Plasma Membrane Transport ProteinsPiperazinesSulfones

Identifiers

PMID40676451
PMCPMC12394303

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.