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The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 135585 XX | Experimental | single dose of BI 135585 |
|
| matching placebo | Placebo Comparator | single dose of matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching placebo | Drug | single dose of matching placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR)) | up to 21 days | |
| Changes in 12-lead ECG (electrocardiogram) | up to 21 days | |
| Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis) | up to 21 days | |
| Occurrence of Adverse events | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | 10 days | |
| Tmax (maximum measured concentration of the analyte in plasma) | 10 days | |
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |
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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 |
|---|---|---|---|---|---|---|
| 1283.5.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
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| BI 135585 XX |
| Drug |
single dose of low, medium or high dose of BI 135585 XX |
|
| 10 days |