Clinical Trial: Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pharmacokinetics, Safety and Tolerability of Nintedanib Single Oral Dose in Male and Female Patients With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) as Compared With N
Brief Summary: The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in comparison with a control group with normal hepatic function following oral administration of nintedanib as single dose.
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome:
- AUC (0-inf) of Nintedanib [ Time Frame: Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration ]AUC (0-inf) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 extrapolated to infinity)
- Cmax of Nintedanib [ Time Frame: Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration ]Cmax (Maximum measured concentration of the Nintedanib in plasma)
Original Primary Outcome:
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity of nintedanib [ Time Frame: 8 days ]
- Maximum measured concentration of the analyte in plasma of nintedanib [ Time Frame: 8 days ]
Current Secondary Outcome:
- AUC (0-tz) of Nintedanib [ Time Frame: Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration ]AUC (0-tz) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)
- Number (%) of Subjects With Drug-related Adverse Events (AEs) [ Time Frame: (AEs) during the 'on-treatment' period (from administration of trial medication until the end of the 28-day residual effect period); Up to 29 days ]Number (%) of subjects with drug-related Adverse events (AEs)
Original Secondary Outcome:
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration of nintedanib [ Time Frame: up to 8 days ]
- Frequency (number in percent) of patients with drug-related adverse events during the on-treatment period. [ Time Frame: up to 28 days ]
Information By: Boehringer Ingelheim
Dates:
Date Received: July 14, 2014
Date Started: July 2014
Date Completion:
Last Updated: December 21, 2015
Last Verified: December 2015