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