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Effect of Activated Charcoal on Mavacamten Pharmacokinetics in Healthy Participants.
Merali, Samira; Chiang, Manting; Sychterz, Caroline; Chao, Longfei; Simmons, Tara; Xu, Yiru; Zhao, Alice; Attanasio, Massimo; Murthy, Bindu; Perera, Vidya.
Afiliación
  • Merali S; Bristol Myers Squibb, Princeton, NJ, USA. samira.merali@bms.com.
  • Chiang M; Bristol Myers Squibb, Princeton, NJ, USA.
  • Sychterz C; Bristol Myers Squibb, Princeton, NJ, USA.
  • Chao L; Bristol Myers Squibb, Princeton, NJ, USA.
  • Simmons T; Bristol Myers Squibb, Princeton, NJ, USA.
  • Xu Y; Bristol Myers Squibb, Princeton, NJ, USA.
  • Zhao A; Cytel Inc., Cambridge, MA, USA.
  • Attanasio M; Bristol Myers Squibb, Princeton, NJ, USA.
  • Murthy B; Bristol Myers Squibb, Princeton, NJ, USA.
  • Perera V; Bristol Myers Squibb, Princeton, NJ, USA.
Am J Cardiovasc Drugs ; 24(4): 569-575, 2024 Jul.
Article en En | MEDLINE | ID: mdl-38926266
ABSTRACT

OBJECTIVE:

To assess the effect of activated charcoal on the single-dose pharmacokinetics of mavacamten when administered 2 h or 6 h after mavacamten dosing.

METHODS:

In this open-label, randomized, parallel-group study, healthy adults were randomized into three groups to receive mavacamten 15 mg alone or mavacamten 15 mg plus activated charcoal 50 g administered either 2 h or 6 h after mavacamten dosing. Pharmacokinetic parameters were derived from plasma concentration-time data using noncompartmental methods.

RESULTS:

Of the 45 participants randomized, 37 completed the study. When activated charcoal was administered 2 h after mavacamten dosing, mavacamten absorption and exposure were reduced compared with when mavacamten was administered alone the area under the concentration-time curve from 0 to 72 h (AUC0-72) and area under the concentration-time curve from time 0 extrapolated to infinity (AUCINF) were reduced by 14% and 34%, respectively. The maximum plasma concentration (Cmax) was also slightly lower when activated charcoal was administered 2 h after mavacamten dosing than with mavacamten alone. Pharmacokinetic profiles were similar for mavacamten alone and mavacamten plus activated charcoal administered 6 h after mavacamten dosing.

CONCLUSIONS:

Activated charcoal was successful in reducing mavacamten absorption and exposure when administered as soon as possible after identification of a need for adsorption (2 h after mavacamten dosing). No change in exposure was observed when activated charcoal was administered 6 h after mavacamten dosing. CLINICAL TRIAL REGISTRATION NCT05320094.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carbón Orgánico / Área Bajo la Curva / Voluntarios Sanos Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Am J Cardiovasc Drugs Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carbón Orgánico / Área Bajo la Curva / Voluntarios Sanos Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Am J Cardiovasc Drugs Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Nueva Zelanda