NCT01651598
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Multiple Rising Doses of BI 144807 Powder for Oral Drinking Solution Over a Period of 14 Days in Otherwise Healthy Controlled Asthmatic Subjects in a Randomised, Double-blind, Placebo-controlled Trial
Overview
- Phase
- Phase 1
- Intervention
- BI 144807
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Number (% patients) of drug-related adverse events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 144807
Subjects receive multiple BID doses of BI 144807 solution
Intervention: BI 144807
Placebo
Subjects receive multiple BID doses of Placebo solution
Intervention: Placebo to BI 144807
Outcomes
Primary Outcomes
Number (% patients) of drug-related adverse events
Time Frame: up to 28 days
Secondary Outcomes
- 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)
Study Sites (1)
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