Evidence map›Paper›PMID 35338177›Full record

Trial reportScientific reports2022

Safety, pharmacokinetics, and pharmacodynamics of milvexian in healthy Japanese participants.

Vidya Perera, Zhaoqing Wang, Susan Lubin, Takayo Ueno, Tomomi Shiozaki, Wei Chen, Xiaohui Xu, Dietmar Seiffert, Mary DeSouza, Bindu Murthy

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% of its field
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  5. Article
  6. Review
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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

10 authors at 2 institutions in 3 countries.

Vidya PereraBristol Myers Squibb, Princeton, NJ, USA. Vidya.Perera@bms.com.ORCID 0000-0002-9055-0123
Zhaoqing WangBristol Myers Squibb, Princeton, NJ, USA.
Susan LubinBristol Myers Squibb, Princeton, NJ, USA.
Takayo UenoBristol-Myers Squibb K.K., Tokyo, Japan.
Tomomi ShiozakiBristol-Myers Squibb K.K., Tokyo, Japan.
Wei ChenBristol Myers Squibb, Princeton, NJ, USA.
Xiaohui XuBristol Myers Squibb, Princeton, NJ, USA.
Dietmar SeiffertBristol Myers Squibb, Princeton, NJ, USA.
Mary DeSouzaBristol Myers Squibb, Princeton, NJ, USA.
Bindu MurthyBristol Myers Squibb, Princeton, NJ, USA.
Bristol-Myers Squibb (United States) · USBristol-Myers Squibb (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This randomized, double-blind, placebo-controlled, multiple ascending-dose study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of milvexian, an oral small-molecule FXIa inhibitor, in healthy Japanese participants. Participants received oral milvexian daily under fasted (50 mg and 200 mg) or fed conditions (500 mg) or placebo over 14 days; 24 participants (8/cohort: 6 milvexian; 2 placebo) were planned. Due to an unblinding event, participants in one cohort (200 mg daily) were discontinued, and a second cohort enrolled; 32 participants were included in safety and pharmacodynamic analyses, and 24/32 in pharmacokinetic analyses. Milvexian up to 500 mg daily for 14 days was generally well tolerated, with no deaths, serious adverse events, or discontinuations due to adverse events. Milvexian exposure increased between 50-mg and 200-mg doses. Median T

Indexed as

Double-Blind MethodAdministration, OralArea Under CurveDose-Response Relationship, DrugHealthy VolunteersHumansJapanPartial Thromboplastin Time

Identifiers

PMID35338177
PMCPMC8956633
OpenAlexW4221087926

What OpenQuestion holds

Textmetadata
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.