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Population Pharmacokinetics of Vamorolone (VBP15) in Healthy Men and Boys With Duchenne Muscular Dystrophy.
Mavroudis, Panteleimon D; van den Anker, John; Conklin, Laurie S; Damsker, Jesse M; Hoffman, Eric P; Nagaraju, Kanneboyina; Clemens, Paula R; Jusko, William J.
Afiliación
  • Mavroudis PD; Department of Pharmaceutical Sciences, University at Buffalo, State University of New York, Buffalo, NY, USA.
  • van den Anker J; ReveraGen Biopharma, Rockville, MD, USA.
  • Conklin LS; Children's National Health System, Washington, DC, USA.
  • Damsker JM; ReveraGen Biopharma, Rockville, MD, USA.
  • Hoffman EP; Children's National Health System, Washington, DC, USA.
  • Nagaraju K; ReveraGen Biopharma, Rockville, MD, USA.
  • Clemens PR; ReveraGen Biopharma, Rockville, MD, USA.
  • Jusko WJ; Binghamton University-SUNY, Binghamton, NY, USA.
J Clin Pharmacol ; 59(7): 979-988, 2019 07.
Article en En | MEDLINE | ID: mdl-30742306
Duchenne muscular dystrophy (DMD) is an inherited neuromuscular disorder occurring in boys and caused by mutations in the dystrophin gene. Vamorolone is a first-generation delta-9,11 compound that has favorable efficacy and side effect profiles relative to classical glucocorticoids. The pharmacokinetics (PK) of oral vamorolone were assessed in parallel-group studies in healthy men (phase 1, n = 86) and boys with DMD (phase 2a, n = 48) during 14 days of once-daily dosing with a range of doses. Vamorolone exhibited moderate variability in PK, with the maximum plasma concentration usually occurring at 2-4 hours and a half-life of approximately 2 hours for all doses and days examined. Population PK modeling of all data together indicated that the PK of vamorolone can be well described by a 1-compartment model with zero-order absorption. Both men and boys showed a dose-linearity of PK parameters for the doses examined, with no accumulation of the drug during daily dosing. Ingestion with food resulted in markedly enhanced absorption of the drug, as tested in healthy men. There were similar PK of vamorolone in healthy men and DMD boys with apparent clearance averaging 2.0 L/h/kg in men and 1.7 L/h/kg in boys. Overall, vamorolone exhibited well-behaved linear PK, with similar profiles in healthy men and boys with DMD, moderate variability in PK parameters, and absorption and disposition profiles similar to those of classical glucocorticoids.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pregnadienodioles / Distrofia Muscular de Duchenne / Antiinflamatorios Tipo de estudio: Prognostic_studies Límite: Adult / Humans / Male / Middle aged Idioma: En Revista: J Clin Pharmacol Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pregnadienodioles / Distrofia Muscular de Duchenne / Antiinflamatorios Tipo de estudio: Prognostic_studies Límite: Adult / Humans / Male / Middle aged Idioma: En Revista: J Clin Pharmacol Año: 2019 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido