Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1060469 | Experimental | single rising doses given as tablet |
|
| Placebo | Placebo Comparator | given as tablet (matching placebo of BI 1060469) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1060469 | Drug | single rising doses given as tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| number of subjects with drug-related adverse events | up to 14 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of BI 1060469 (Cmax) | up to 72 hours after drug administration | |
| Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity) | up to 72 hours after drug administration |
Not provided
Inclusion criteria:
Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
Chinese ethnicity, Japanese ethnicity according to the following criteria:
Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan
Age within the range of 18 to 45 years
Body mass index within the range of 18.5 and 25 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice(GCP) and local legislation.
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1333.3.82002 Boehringer Ingelheim Investigational Site | Busan | South Korea | ||||
| 1333.3.82001 Boehringer Ingelheim Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
given as tablet (matching placebo of BI 1060469) |
|
| Area Under the concentration-time curve of BI 1060469 (AUC0- tz) | up to 72 hours after drug administration |
| Seoul |
| South Korea |