Clinical Trial: Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label, Single-dose Study to Assess the Pharmacokinetics of Oral Everolimus (Afinitor®) in Subjects With Impaired Hepatic Function

Brief Summary: This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Evaluate the pharmacokinetics of a single oral dose of everolimus in subjects with severely impaired hepatic function (Child-Pugh C) relative to healthy controls. Measure: AUC, Cmax, tmax, λz, Vd/F, CL/F and t1/2 [ Time Frame: First 8 days ]

Original Primary Outcome: Evaluate the pharmacokinetics of a single oral dose of everolimus in subjects with severely impaired hepatic function (Child-Pugh C) relative to healthy controls. Measure: AUC, Cmax, tmax, λz, Vd/F, CL/F and t1/2 [ Time Frame: 8 days ]

Current Secondary Outcome:

  • Evaluate the pharmacokinetics of a single oral dose of everolimus in subjects with mild and moderate impaired hepatic function (Child-Pugh A and B, respectively) relative to healthy controls. [ Time Frame: First 8 days ]
  • Assess the safety and tolerability of a single oral dose of everolimus in subjects with impaired hepatic function (Child-Pugh A, B, and C). [ Time Frame: First 8 days plus day 15 and day 28 post-dose follow-ups for safety ]
  • Explore correlation between pharmacokinetics and hepatic function parameters [ Time Frame: First 8 days ]


Original Secondary Outcome:

  • Evaluate the pharmacokinetics of a single oral dose of everolimus in subjects with mild and moderate impaired hepatic function (Child-Pugh A and B, respectively) relative to healthy controls. [ Time Frame: 8 days ]
  • Assess the safety and tolerability of a single oral dose of everolimus in subjects with impaired hepatic function (Child-Pugh A, B, and C). [ Time Frame: 8 days plus 15-day and 28-day post-dose follow-ups for safety ]
  • Explore correlation between pharmacokinetics and hepatic function parameters [ Time Frame: 8 days ]


Information By: Novartis

Dates:
Date Received: August 27, 2009
Date Started: November 2009
Date Completion:
Last Updated: April 20, 2016
Last Verified: April 2016