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

• Main Authors: Michael D. Aleo (Author), Jiri Aubrecht (Author), Paul D. Bonin (Author), Deborah A. Burt (Author), Jennifer Colangelo (Author), Lina Luo (Author), Shelli Schomaker (Author), Rachel Swiss (Author), Simon Kirby (Author), Greg C. Rigdon (Author), Pinky Dua (Author)
• Format: Book
• Published: Wiley, 2019-02-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract 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 cynomolgu...