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

NCT ID: NCT01917916

Last Updated: 2023-08-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-05

Study Completion Date

2014-05-14

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BI 655064 dose group 1 - 80 mg

Group Type EXPERIMENTAL

BI 655064

Intervention Type DRUG

Solution for subcutaneous (s.c.) injection.

BI 655064 dose group 2 - 120 mg

Group Type EXPERIMENTAL

BI 655064

Intervention Type DRUG

Solution for subcutaneous (s.c.) injection.

BI 655064 dose group 3 - 180 mg

Group Type EXPERIMENTAL

BI 655064

Intervention Type DRUG

Solution for subcutaneous (s.c.) injection.

BI 655064 dose group 4 - 240 mg

Group Type EXPERIMENTAL

BI 655064

Intervention Type DRUG

Solution for subcutaneous (s.c.) injection.

Placebo matching BI 655064

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution for subcutaneous (s.c.) injection.

Interventions

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Placebo

Solution for subcutaneous (s.c.) injection.

Intervention Type DRUG

BI 655064

Solution for subcutaneous (s.c.) injection.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1293.8.8101 Boehringer Ingelheim Investigational Site

Sumida-ku,Tokyo, , Japan

Site Status

1293.8.8201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

Countries

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Japan South Korea

Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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1293.8

Identifier Type: -

Identifier Source: org_study_id

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