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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 655064; Drug: Placebo

• Registration Number: NCT01917916
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-02
• Study Start: 2013-08-05
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-07
• Primary Completion: 2014-05-14
• Study Completion: 2014-05-14
• Status Verified: 2022-09
• Results First Submitted: 2022-09-26
• Results First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Results First Posted: 2023-08-09
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 655064 dose group 4 - 240 mg	BI 655064	-
BI 655064 dose group 1 - 80 mg	BI 655064	-
BI 655064 dose group 3 - 180 mg	BI 655064	-
BI 655064 dose group 2 - 120 mg	BI 655064	-
Placebo matching BI 655064	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Investigator Defined Drug-related Adverse Events	From study drug administration until end-of-study examination, up to 77 days.	Number of participants with investigator defined drug-related adverse events (AEs) is reported.

Secondary Outcome Measures

Name	Time	Method
Maximum Measured Concentration of BI 655064 in Plasma (Cmax)	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.	Maximum measured concentration of BI 655064 in plasma (Cmax) is reported.
Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	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.	Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
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)	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.	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.

Trial Locations

Locations (2)

1293.8.8201 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1293.8.8101 Boehringer Ingelheim Investigational Site; 🇯🇵 Sumida-ku,Tokyo, Japan