Phase I study of PF‐04895162, a Kv7 channel opener, reveals unexpected hepatotoxicity in healthy subjects, but not rats or monkeys: clinical evidence of disrupted bile acid homeostasis

During a randomized Phase 1 clinical trial the drug candidate, PF‐04895162 (ICA‐105665), caused transaminase elevations (≥grade 1) in six of eight healthy subjects treated at 300 mg twice daily for 2‐weeks (NCT01691274). This was unexpected since studies in rats (<6 months) and cynomolgus monkeys...

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Detalles Bibliográficos
Autores principales: Aleo, Michael D., Aubrecht, Jiri, D. Bonin, Paul, Burt, Deborah A., Colangelo, Jennifer, Luo, Lina, Schomaker, Shelli, Swiss, Rachel, Kirby, Simon, C. Rigdon, Greg, Dua, Pinky
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6370995/
https://www.ncbi.nlm.nih.gov/pubmed/30784208
http://dx.doi.org/10.1002/prp2.467

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6370995/
https://www.ncbi.nlm.nih.gov/pubmed/30784208
http://dx.doi.org/10.1002/prp2.467

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