Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 144807; Drug: BI 144807 Placebo

• Registration Number: NCT01480648
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-24
• Study First Posted: 2011-11-29
• Primary Completion: 2012-02
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 74

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
BI144807	BI 144807	Subjects receive a single oral dose of BI144807solution
Placebo	BI 144807 Placebo	Subjects receive a single oral dose of placebo solution

Primary Outcome Measures

Name	Time	Method
Number of participants with clinically significant changes in laboratory tests	up to 14 days postdose
Number of participants tolerating BI 144807	up to 14 days postdose
Number of participants with clinically significant changes in ECG	up to 14 days postdose
Number of participants with clinically significant changes in physical examination	up to 14 days postdose
All adverse events	up to 14 days postdose
Number of participants with clinically significant changes in vital signs	up to 14 days postdose

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	up to 72h postdose
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 72h postdose
AUC(0-tz) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)	up to 72h postdose
tmax (time from dosing to maximum measured concentration)	up to 72h postdose
t1/2 (terminal half-life of the analyte in plasma)	up to 72h postdose

Trial Locations

Locations (1)

1313.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany