Status:
COMPLETED
Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria. Japanese: born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who were all born in Japan. Chinese: ethnic 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
- Age within the range of 20 to 45 years inclusive
- Body mass index within the range of 18.5 and 25 kg/m2 inclusive
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
- Exclusion criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any disease or clinically relevant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the subject or interfere with the subjects participation in the trial or compromise the trial objectives
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections
Exclusion
Key Trial Info
Start Date :
August 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01917916
Start Date
August 5 2013
End Date
May 14 2014
Last Update
August 9 2023
Active Locations (2)
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1
1293.8.8101 Boehringer Ingelheim Investigational Site
Sumida-ku,Tokyo, Japan
2
1293.8.8201 Boehringer Ingelheim Investigational Site
Seoul, South Korea