The main objectives of the present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg \[14C\]BI 671800 HEA to healthy male volunteers. Secondary objectives are to evaluate the safety and tolerability following a single oral dose of 400 mg \[14C\]BI 671800 HEA to healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
High dose oral drinking solution
1268.7.001 Boehringer Ingelheim Investigational Site
Madison, Wisconsin, United States
Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces
Time frame: up to 336 h post treatment
Individual time course profiles of BI 671800 and its major metabolite CD6384 in plasma and urine
Time frame: up to 336 h post treatment
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time frame: up to 336 h post treatment
Elucidation of metabolite structures and identification of major metabolites in plasma, urine, and faeces (if feasible) in comparison with various animal species (to be presented in a separate report)
Time frame: up to 336 h post treatment
Cblood cells/Cplasma ratio of 14C-radioactivity
Time frame: up to 168 h post treatment
concentrations of BI 671800 and its metabolite CD6384 in plasma and urine
Time frame: up to 336 h post treatment
concentrations of 14C-radioactivity in whole blood, plasma, urine, and faeces
Time frame: up to 336 h post treatment
Changes from Baseline in Vital signs (pulse rate)
Time frame: up to 23 days post treatment
Changes from Baseline in Physical examination
Time frame: up to 23 days post treatment
Changes from Baseline in Vital signs (blood pressure)
Time frame: up to 23 days post treatment
Changes from Baseline in 12-lead electrocardiogram (ECG)
Time frame: up to 23 days post treatment
Changes from Baseline in Clinical laboratory tests
Time frame: up to 23 days post treatment
Occurrence of Adverse Events
Time frame: up to 23 days post treatment
Assessment of tolerability by investigator
Time frame: up to 23 days post treatment
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