Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers

Phase 1

Completed

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

• Registration Number: NCT01510782
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-16
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 655064 subcutaneous	BI 655064	Escalating single dose as solution for subcutaneous injection
Placebo to BI 655064 subcutaneous	Placebo to BI 655064	Escalation single dose as solution for subcutaneous injection (Placebo)
BI 655064 intravenous	BI 655064	Escalating single dose as solution for intravenous infusion
Placebo to BI 655064 intravenous	Placebo to BI 655064	Escalating single dose as solution for intravenous infusion (Placebo)

Primary Outcome Measures

Name	Time	Method
Changes in 12-lead ECG (electrocardiogram)	up to 70 days post treatment
Assessment of local tolerability by investigator	up to 70 days post treatment
Changes in vital signs (blood pressure [BP], pulse rate [PR])	up to 70 days post treatment
Incidence of adverse events	up to 70 days post treatment
Assessment of global tolerability by investigator	up to 70 days post treatment

Secondary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma	up to 1656 hours post treatment
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	up to 1656 hours post treatment
Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose	up to 1656 hours post treatment

Trial Locations

Locations (1)

1293.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany