Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of \[14C\]-BI 207127 and to characterize the metabolic profile following single dose administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA
1241.22.001 Boehringer Ingelheim Investigational Site
Madison, Wisconsin, United States
AUC0-infinity of Plasma Deleobuvir
Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)
Time frame: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration
Cmax of Plasma Deleobuvir
Maximum measured concentration (Cmax) of plasma deleobuvir
Time frame: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration
t1/2 of [14C]-Radioactivity in Plasma
Terminal half life (T1/2) of \[14C\]-radioactivity in plasma
Time frame: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration
Excretion Balance of Total [14C]-Radioactivity
Excretion balance of total \[14C\]-radioactivity (urine and faeces)
Time frame: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration
Excretion of Total [14C]-Radioactivity in Urine
Excretion of total \[14C\]-radioactivity in urine
Time frame: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration
Excretion of Total [14C]-Radioactivity in Faeces
Excretion of total \[14C\]-radioactivity in faeces
Time frame: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration
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