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About
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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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