Evidence map›Paper›PMID 39014868›Full record

ArticleClinical and translational science2024

Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different CYP2C19 phenotypes.

Xiaojie Wu, Nanye Chen, Peiwen Hsu, Jing Sun, Wenting Li, Qi Wang, Merali Samira, Qiong Wei, Jicheng Yu, Guoying Cao and 9 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
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

19 authors.

Xiaojie WuPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Nanye ChenPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Peiwen HsuShanghai LianBio Development Co., Ltd, Shanghai, China.
Jing SunBristol Myers Squibb, Shanghai, China.
Wenting LidMed Biopharmaceutical Co., Ltd, Shanghai, China.
Qi WangBristol Myers Squibb, Shanghai, China.
Merali SamiraBristol Myers Squibb, New Brunswick, New Jersey, USA.ORCID 0000-0001-6659-3687
Qiong WeiPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Jicheng YuPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Guoying CaoPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Haijing YangPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Lili WangPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Jingjing WangPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Yi JinPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Wei LiuPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Jufang WuPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Jinjie HePhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Cheng LyuShanghai LianBio Development Co., Ltd, Shanghai, China.
Jing ZhangPhase 1 Clinical Research Center, Huashan Hospital, Fudan University, Shanghai, China.ORCID 0000-0003-2966-9149

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Obstructive hypertrophic cardiomyopathy (oHCM) is a subtype of HCM characterized by left ventricular outflow tract obstruction resulting from cardiac muscle hypertrophy and anatomic alterations in the mitral valve and apparatus. Mavacamten, a cardiac myosin inhibitor metabolized primarily by CYP2C19 in the liver, is the first and only targeted medication approved for the treatment of symptomatic New York Heart Association (NYHA) class II-III oHCM. Previous pharmacokinetic (PK) results of mavacamten in healthy Caucasian, Japanese, and Asian participants demonstrated that mavacamten exposure was affected by CYP2C19 metabolism status. This open-label, parallel-group, phase I trial aimed to determine the PK and safety of mavacamten in healthy Chinese participants with different CYP2C19 genotypes. The primary outcome was to define the PK of mavacamten in healthy Chinese participants; the secondary outcome was to examine safety and tolerability. After a single oral dose of 15 or 25 mg mavacamten in fasted healthy adult Chinese individuals, C

Indexed as

BenzylaminesCytochrome P-450 CYP2C19UracilAdministration, OralAdultChinaEast Asian PeopleFemaleGenotypeHalf-LifeHealthy VolunteersHumansMaleMiddle AgedPhenotypeYoung AdultBenzylaminesCYP2C19 protein, humanCytochrome P-450 CYP2C19MYK-461Uracil

Identifiers

PMID39014868
PMCPMC11252221

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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.