A Phase 1 Dose-Escalation Study of the Cardiac Myosin Inhibitor Aficamten in Healthy Participants.

Malik, Fady I; Robertson, Laura A; Armas, Danielle R; Robbie, Edward P; Osmukhina, Anna; Xu, Donghong; Li, Hanbin; Solomon, Scott D

Malik, Fady I; Robertson, Laura A; Armas, Danielle R; Robbie, Edward P; Osmukhina, Anna; Xu, Donghong; Li, Hanbin; Solomon, Scott D.

Afiliación

Malik FI; Research and Development, Cytokinetics, Inc, South San Francisco, California, USA.
Robertson LA; Research and Development, Cytokinetics, Inc, South San Francisco, California, USA.
Armas DR; Celerion, Inc, Tempe, Arizona, USA.
Robbie EP; Research and Development, Cytokinetics, Inc, South San Francisco, California, USA.
Osmukhina A; Research and Development, Cytokinetics, Inc, South San Francisco, California, USA.
Xu D; Research and Development, Cytokinetics, Inc, South San Francisco, California, USA.
Li H; Certara, Inc, Menlo Park, California, USA.
Solomon SD; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.

JACC Basic Transl Sci ; 7(8): 763-775, 2022 Aug.

Article en En | MEDLINE | ID: mdl-36061336

Palabras clave

AE, adverse event; AUC24, area under the plasma concentrationtime curve from time 0 to 24 hours; CV%,, percent coefficient of variation; CYP, cytochrome P450; CYP2D6-PM, cytochrome P450 2D6 poor metabolizer phenotype; Cmax, maximum plasma drug concentration; DLRC, Dose Level Review Committee; ECG, electrocardiogram; HCM, hypertrophic cardiomyopathy; LV contractility; LV, left ventricle; LVEDV, left ventricular end-diastolic volume; LVEF, left ventricular ejection fraction; LVESV, left ventricular end-systolic volume; MAD, multiple ascending dose; PD, pharmacodynamic; PK, pharmacokinetic; QTcF, QT interval corrected for heart rate using Fridericia's formula; SAD, single ascending dose; TEAE, treatment-emergent adverse event; aficamten; cardiac myosin inhibitor; hypertrophic cardiomyopathy; phase 1

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: JACC Basic Transl Sci Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos

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