Clinical trial NCT01651598: Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion criteria:

1. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)

Exclusion criteria:

1. Apart from mild asthma any relevant deviation from healthy conditions

Primary outcomes:
measure: Number (% patients) of drug-related adverse events
timeFrame: up to 28 days
Secondary outcomes:
measure: Maximum measured concentration of the analyte in plasma after first dose (Cmax)
timeFrame: up to 24 hours after first dose
measure: Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)
timeFrame: up to 72 hours after last dose
measure: Time from first dosing to maximum measured concentration (Tmax)
timeFrame: up to 24 hours after first dose
measure: Time from last dosing to maximum measured concentration (Tmax,ss)
timeFrame: up to 72 hours after last dose
measure: 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)
timeFrame: up to 24 hours after first dose
measure: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)
timeFrame: up to 72 hours after last dose
measure: Terminal half-life of the analyte in plasma after the first dose (t1/2)
timeFrame: up to 24 hours after first dose
measure: Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
timeFrame: up to 72 hours after last dose
measure: 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)
timeFrame: up to 72 hours after last dose
measure: 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)
timeFrame: up to 72 hours after last dose
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: 1313.2.44001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: