Clinical Trial: Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Volunteers

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

Official Title: Pharmacokinetics, Safety and Tolerability of Single Dose BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Subjects (An Open Label, Matched Pair, Two Center Study)

Brief Summary: To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic impairment in comparison to healthy subjects

Detailed Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome: Plasma concentration-time profiles of the analytes at different time points [ Time Frame: Up to 84 hours after drug administration ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum measured concentration of BIIL 315 ZW in plasma (Cmax) [ Time Frame: Up to 84 hours after drug administration ]
  • Time from dosing to the maximum concentration of BIIL 315 ZW in plasma (tmax) [ Time Frame: Up to 84 hours after drug administration ]
  • Area under the concentration-time curve of BIIL 315 ZW in plasma at different time points (AUC) [ Time Frame: Up to 84 hours after drug administration ]
  • Terminal half-life of BIIL 315 ZW in plasma (t1/2) [ Time Frame: Up to 84 hours after drug administration ]
  • Total mean residence time of BIIL 315 ZW in the body (MRTtot) [ Time Frame: Up to 84 hours after drug administration ]
  • Total apparent clearance of BIIL 315 ZW in plasma after oral administration (CLtot/F) [ Time Frame: Up to 84 hours after drug administration ]
  • Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) [ Time Frame: Up to 84 hours after drug administration ]
  • Number of patients with clinically relevant findings in vital signs [ Time Frame: Up to 4 days after drug administration ]
    blood pressure, pulse rate
  • Changes from baseline in spirometry [ Time Frame: Pre-dose and 1 hour after drug administration ]
  • Number of patients with clinically relevant findings in laboratory tests [ Time Frame: Up to 4 days after drug administration ]
  • Number of patients with clinically relevant findings in 12-lead ECG [ Time Frame: Up to 4 days after drug administration ]
  • Changes from baseline in physical examination [ Time Frame: Pre-dose and 4 days after drug administration ]
  • Number of patients with adverse events [ Time Frame: Up to 11 days after drug administration ]


Original Secondary Outcome: Same as current

Information By: Boehringer Ingelheim

Dates:
Date Received: October 15, 2014
Date Started: March 2000
Date Completion:
Last Updated: October 15, 2014
Last Verified: October 2014