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

Healthy Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655064 (Buffer Solution for Injection) in Healthy Chinese and Japanese Male Volunteers (Randomised, Double-blind, Placebocontrolled Within Dose Groups, Clinical Phase I Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917916
• Other study ID #: 1293.8
• Status: Completed
• Phase: Phase 1
• Start date: August 5, 2013
• Est. completion date: May 14, 2014

Study information

• Verified date: September 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 14, 2014
• Est. primary completion date: May 14, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo
Solution for subcutaneous (s.c.) injection.
• BI 655064
Solution for subcutaneous (s.c.) injection.

Locations

Country	Name	City	State
Japan	1293.8.8101 Boehringer Ingelheim Investigational Site	Sumida-ku,Tokyo
Korea, Republic of	1293.8.8201 Boehringer Ingelheim Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Investigator Defined Drug-related Adverse Events	Number of participants with investigator defined drug-related adverse events (AEs) is reported.	From study drug administration until end-of-study examination, up to 77 days.
Secondary	Maximum Measured Concentration of BI 655064 in Plasma (Cmax)	Maximum measured concentration of BI 655064 in plasma (Cmax) is reported.	Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Secondary	Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-8)	Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8) is reported.	Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Secondary	Area Under the Concentration-time Curve of the Analyte BI 655064 in the Plasma Over the Time Interval From 0 to the Last Measurable Time Point (AUC0-tz)	Area under the concentration-time curve of the analyte BI 655064 in the plasma over the time interval from 0 to the last measurable time point (AUC0-tz) is reported.	Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.

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