Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

Phase 1

Completed

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

• Registration Number: NCT01651598
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 144807	BI 144807	Subjects receive multiple BID doses of BI 144807 solution
Placebo	Placebo to BI 144807	Subjects receive multiple BID doses of Placebo solution

Primary Outcome Measures

Name	Time	Method
Number (% patients) of drug-related adverse events	up to 28 days

Secondary Outcome Measures

Name	Time	Method
Time from last dosing to maximum measured concentration (Tmax,ss)	up to 72 hours after last dose
Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2)	up to 24 hours after first dose
Time from first dosing to maximum measured concentration (Tmax)	up to 24 hours after first dose
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)	up to 72 hours after last dose
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)	up to 72 hours after last dose
Maximum measured concentration of the analyte in plasma after first dose (Cmax)	up to 24 hours after first dose
Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)	up to 72 hours after last dose
Terminal half-life of the analyte in plasma after the first dose (t1/2)	up to 24 hours after first dose
RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose)	up to 72 hours after last dose
RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose)	up to 72 hours after last dose

Trial Locations

Locations (1)

1313.2.44001 Boehringer Ingelheim Investigational Site; 🇬🇧 Manchester, United Kingdom