Pharmacokinetics of Cabotegravir in Subjects with Moderate Hepatic Impairment

Pharmacokinetics of Cabotegravir in Subjects with Moderate Hepatic Impairment

Pharmacokinetics of Cabotegravir in Subjects with Severe Renal Impairment

Population Pharmacokinetics of Isavuconazole in Subjects with Mild or Moderate Hepatic Impairment

Isavuconazole, administered as the prodrug isavuconazonium sulfate, was recently approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of adults with invasive aspergillosis and mucormycosis. The objective of this analysis was to develop a population pharmacokinetic model using NONMEM (version 7.2) for subjects with hepatic impairment, using intrav...

Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment.

Two open-label, single-dose, parallel-group studies were conducted to characterize the pharmacokinetics of the novel antibacterial tedizolid and the safety of tedizolid phosphate, its prodrug, in renally or hepatically impaired subjects. Tedizolid pharmacokinetics in subjects with severe renal impairment without dialysis support was compared with that of matched control subjects with normal ren...

Safety and Pharmacokinetics of Solithromycin in Subjects with Hepatic Impairment.

Solithromycin, a new macrolide and the first fluoroketolide, is in late-stage clinical development and, like older macrolides, is primarily metabolized and excreted through liver-dependent mechanisms. This study evaluated the safety and pharmacokinetics of solithromycin in patients with chronic liver disease. This open-label, multiple-dose study in subjects with hepatic impairment and in health...