Evidence map›Paper›PMID 41549794›Full record

Trial reportClinical pharmacology in drug development2026

A Thorough QT Study to Assess the Effects of Milvexian on Cardiac Repolarization in Healthy Participants.

Peter Zannikos, JongHanne Park, Anna Dari, Samiha Takhtoukh, Paul Levesque, Alexei N Plotnikov, Amitava Mitra, Antoinette Ajavon-Hartmann, Samira Merali, Juan Jose Perez Ruixo and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. 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. Review
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.

Peter ZannikosJohnson & Johnson, Raritan, NJ, USA.
JongHanne ParkJohnson & Johnson, Raritan, NJ, USA.
Anna DariJohnson & Johnson, Beerse, Belgium.
Samiha TakhtoukhJohnson & Johnson, Beerse, Belgium.
Paul LevesqueBristol Myers Squibb, Princeton, NJ, USA.
Alexei N PlotnikovJohnson & Johnson, Raritan, NJ, USA.
Amitava MitraKura Oncology, Inc., Boston, MA, USA.
Antoinette Ajavon-HartmannBristol Myers Squibb, Princeton, NJ, USA.
Samira MeraliBristol Myers Squibb, Princeton, NJ, USA.
Juan Jose Perez RuixoJohnson & Johnson, Beerse, Belgium.
Navin GoyalJohnson & Johnson, Raritan, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Milvexian is an oral factor XIa inhibitor in development for prevention of major thromboembolic conditions. This randomized, double-blind, placebo- and positive-controlled, multiple-dose, four-period crossover study assessed the cardic safety of milvexian (including effects on the QT interval of the electrocardiogram), with a supporting in vitro component. Sixty-six participants were enrolled. In each treatment period, participants received milvexian (100 or 200 mg) or placebo every 12 h for 4 days. A single-dose moxifloxacin (400 mg) served as a positive control. Electrocardiographs and time-matched pharmacokinetic samples were collected during each period. In mixed-effects models, the upper limit of the two-sided 90% confidence interval for the least squares means for change from baseline QTc (Fridericia [QTcF], as the primary correction method) for milvexian versus placebo (ΔΔQTc) was ˂10 ms at all time points after each milvexian regimen. In addition, there was no apparent relationship between ΔΔQTcF and plasma milvexian concentrations. Moxifloxacin response confirmed assay sensitivity. Milvexian inhibited human ether-a-go-go-related gene potassium, sodium, and L-type calcium ion channel currents with weak-to-moderate potency at concentrations exceeding the highest mean unbound maximum plasma concentrations of TQT study participants. Milvexian regimens were safe and well tolerated. These data indicate that milvexian does not prolong the QTc interval at clinically relevant concentrations.

Indexed as

AdultCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodElectrocardiographyFemaleHealthy VolunteersHeart RateHumansLong QT SyndromeMaleMiddle AgedMoxifloxacinPyrimidinesTriazolesYoung AdultmilvexianMoxifloxacinPyrimidinesTriazolesmilvexianpharmacokineticsQTrepolarizationsafety

Identifiers

PMID41549794
PMCPMC12813654

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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.