Evidence map›Paper›PMID 35906349›Full record

Trial reportClinical pharmacokinetics2022

Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment.

Vidya Perera, Grigor Abelian, Danshi Li, Zhaoqing Wang, Liping Zhang, Susan Lubin, Akintunde Bello, Bindu Murthy

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03196206 (An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.9field-weighted citation impact, top 8% 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.

NCT03196206 phase1completednot on this map

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment

TypeinterventionalSponsorBristol-Myers SquibbRan2017 to 2018Enrolled24ConditionsThrombosisArmsBMS-986177
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 22 citations in OpenAlex.

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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

8 authors at 2 institutions in 3 countries.

Vidya PereraBristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA. Vidya.Perera@bms.com.ORCID 0000-0002-9055-0123
Grigor AbelianBristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA.
Danshi LiBristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA.
Zhaoqing WangBristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA.
Liping ZhangJanssen Research & Development, LLC, Titusville, NJ, USA.
Susan LubinBristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA.
Akintunde BelloBristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA.
Bindu MurthyBristol Myers Squibb, 3401 Princeton Pike, Lawrenceville, NJ, 08648, USA.
Bristol-Myers Squibb (United States) · USJanssen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to assess the effect of moderate or severe renal impairment on the pharmacokinetic (PK) properties of milvexian.

methodsThis open-label, parallel-group study assessed the PK, safety, and tolerability of a single oral 60 mg dose of milvexian in participants with normal renal function (n = 8; estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m

resultsMilvexian was well tolerated, with no deaths, serious adverse events, or serious bleeding reported. The maximum milvexian concentration (C

conclusionA single dose of milvexian 60 mg was safe and well tolerated in participants with normal renal function and moderate or severe renal impairment. There was a similar increase in milvexian exposure between the moderate and severe renal groups. CLINICAL TRIALS REGISTRATION: This study was registered with ClinicalTrials.gov (NCT03196206, first posted 22 June 2017).

Indexed as

Renal InsufficiencyArea Under CurveGlomerular Filtration RateHalf-LifeHumansKidney

Identifiers

PMID35906349
PMCPMC9553801
OpenAlexW4288685273

What OpenQuestion holds

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LicenceCC BY-NC
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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.