Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 655064; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01917916

1293.8

Details and patient eligibility

About

Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.

Enrollment: 64 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 5 patient groups, including a placebo group

BI 655064 dose group 1 - 80 mg

Experimental group

Treatment:

Drug: BI 655064

BI 655064 dose group 2 - 120 mg

Experimental group

Treatment:

Drug: BI 655064

BI 655064 dose group 3 - 180 mg

Experimental group

Treatment:

Drug: BI 655064

BI 655064 dose group 4 - 240 mg

Experimental group

Treatment:

Drug: BI 655064

Placebo matching BI 655064

Placebo Comparator group

Treatment:

Drug: Placebo