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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016370-32 | EudraCT Number | EudraCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 671800 high dose | Experimental | Oral drinking solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 671800 | Drug | High dose oral drinking solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces | up to 336 h post treatment | |
| Individual time course profiles of BI 671800 and its major metabolite CD6384 in plasma and urine | up to 336 h post treatment | |
| Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces | 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) | up to 336 h post treatment | |
| Cblood cells/Cplasma ratio of 14C-radioactivity | up to 168 h post treatment | |
| concentrations of BI 671800 and its metabolite CD6384 in plasma and urine | up to 336 h post treatment | |
| concentrations of 14C-radioactivity in whole blood, plasma, urine, and faeces | up to 336 h post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline in Vital signs (pulse rate) | up to 23 days post treatment | |
| Changes from Baseline in Physical examination | up to 23 days post treatment | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1268.7.001 Boehringer Ingelheim Investigational Site | Madison | Wisconsin | United States |
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| Changes from Baseline in Vital signs (blood pressure) |
| up to 23 days post treatment |
| Changes from Baseline in 12-lead electrocardiogram (ECG) | up to 23 days post treatment |
| Changes from Baseline in Clinical laboratory tests | up to 23 days post treatment |
| Occurrence of Adverse Events | up to 23 days post treatment |
| Assessment of tolerability by investigator | up to 23 days post treatment |
| ID | Term |
|---|---|
| C000605880 | BI 671800 |
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