Clinical Trial: Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency

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

Official Title: An Open-label Study to Determine the Pharmacokinetics of Single-dose and/or Steady-state TPV/r 500/200 mg in Subjects With Mild and Moderate Hepatic Insufficiency

Brief Summary: To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome:

  • AUC0-∞ (area under the concentration time curve of drug in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to day 12 after first drug administration ]
  • AUC0-12h (area under the concentration time curve of drug in plasma over the time interval from 0 to 12h) [ Time Frame: Up to 12 hours after drug administration ]
  • Cmax (maximum concentration of drug in plasma) [ Time Frame: Up to day 12 after first drug administration ]
  • Cp12h (drug concentration in plasma at 12 hours after administration) for the mild hepatic subjects [ Time Frame: Up to 12 hours (h) after drug administration ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • time from dosing to the maximum concentration (tmax) [ Time Frame: Up to day 12 after first drug administration ]
  • elimination half-life (t1/2) [ Time Frame: Up to day 12 after first drug administration ]
  • oral clearance (CL/F) [ Time Frame: Up to day 12 after first drug administration ]
  • volume of distribution (Vz/F) [ Time Frame: Up to day 12 after first drug administration ]
  • Relationship between pharmacokinetic parameters and baseline covariates [ Time Frame: Up to day 12 after first drug administration ]
    Covariates = age, weight, race, cigarette smoking and hepatic impairment
  • Relationship between pharmacokinetic parameters and baseline covariates [ Time Frame: Up to day 12 after first drug administration ]
    Covariates = age, weight, race, cigarette smoking and the child-Pugh score as linear and quadratic terms
  • Number of patients with abnormal changes in clinical laboratory parameters [ Time Frame: Up to day 12 after first drug administration ]
  • Number of patients with adverse events [ Time Frame: Up to day 12 after first drug administration ]


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: September 23, 2014
Date Started: October 2003
Date Completion:
Last Updated: September 25, 2014
Last Verified: September 2014