Evidence map›Paper›PMID 40424304›Full record

Trial reportClinical pharmacology in drug development2025

A Randomized Thorough QT Trial Using Concentration-QT Analysis to Evaluate the Effects of Centanafadine on Cardiac Repolarization.

Osman S Turkoglu, Xiaofeng Wang, Jennifer Repella-Gordon, Susan E Shoaf

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

1 citing paper in PubMed.

  1. Trial
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.

Osman S TurkogluOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA.
Xiaofeng WangOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA.
Jennifer Repella-GordonOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA.
Susan E ShoafOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Centanafadine is a norepinephrine/dopamine/serotonin reuptake inhibitor in development for treatment of attention-deficit/hyperactivity disorder. This double-blind, placebo- and moxifloxacin-controlled, 3-period crossover trial evaluated the effects of centanafadine (EB-1020) and its metabolite (EB-10601) on cardiac repolarization in 30 healthy adults (18-65 years). Dosing sequences included centanafadine sustained-release 800 mg (supratherapeutic) total daily dose, placebo, and moxifloxacin 400 mg. Electrocardiogram parameters and heart rate (HR) were assessed. The primary endpoint was placebo-corrected change from baseline QTc (ΔΔQTc), analyzed using concentration-QTc (C-QTc) analysis. The C-QTc slopes for centanafadine (-0.001 ms/[ng/mL]) and EB-10601 (-0.0003 ms/[ng/mL]) were not statistically significant. Assay sensitivity was confirmed by the statistically significant C-QTc slope for moxifloxacin (0.004 ms/[ng/mL]) and a 2-sided 90% confidence interval lower bound >5 milliseconds. No change from baseline in QTcF or placebo-corrected QTcF ≥10 milliseconds for centanafadine was observed at any postdose time point. No centanafadine-treated participants had QTcF increases of >30 milliseconds and no relevant PR/QRS interval or HR increases were observed. The predicted ΔΔQTcF values of centanafadine, EB-10601, and moxifloxacin at the geometric mean C

Indexed as

Heart RateAdolescentAdultAgedCross-Over StudiesDelayed-Action PreparationsDouble-Blind MethodElectrocardiographyFemaleHealthy VolunteersHumansLong QT SyndromeMaleMiddle AgedMoxifloxacinYoung AdultDelayed-Action PreparationsMoxifloxacinattention‐deficit/hyperactivity disordercardiac repolarizationelectrocardiogramspharmacokineticsQT prolongation

Identifiers

PMID40424304
PMCPMC12314114

What OpenQuestion holds

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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.