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Open-Label Single-Dose Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of Mirogabalin.

Kenneth DuchinGiorgio SenaldiVance WarrenThomas MarburyKenneth LasseterHamim Zahir
Published in: Clinical drug investigation (2018)
Mild hepatic impairment resulted in lower A200-700 and A204-4455 exposure, while moderate hepatic impairment did not affect A200-700 exposure. Overall, mild-to-moderate hepatic impairment did not have a significant effect on mirogabalin exposure. A single 15-mg dose of mirogabalin was well tolerated by subjects with mild or moderate hepatic impairment.
Keyphrases
  • open label
  • high intensity
  • clinical trial
  • squamous cell carcinoma
  • rectal cancer
  • phase iii