Back to resultsMultiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
Primary Purpose
Healthy, Asthma
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo to BI 144807
BI 144807
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
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
Sites / Locations
- 1313.2.44001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BI 144807
Placebo
Arm Description
Subjects receive multiple BID doses of BI 144807 solution
Subjects receive multiple BID doses of Placebo solution
Outcomes
Primary Outcome Measures
Number (% patients) of drug-related adverse events
Secondary Outcome Measures
Maximum measured concentration of the analyte in plasma after first dose (Cmax)
Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)
Time from first dosing to maximum measured concentration (Tmax)
Time from last dosing to maximum measured concentration (Tmax,ss)
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)
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)
Terminal half-life of the analyte in plasma after the first dose (t1/2)
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01651598
Brief Title
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
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BI 144807
Arm Type
Experimental
Arm Description
Subjects receive multiple BID doses of BI 144807 solution
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive multiple BID doses of Placebo solution
Intervention Type
Drug
Intervention Name(s)
Placebo to BI 144807
Intervention Description
multiple dose (bid)
Intervention Type
Drug
Intervention Name(s)
BI 144807
Intervention Description
multiple dose (bid, low to high dose)
Primary Outcome Measure Information:
Title
Number (% patients) of drug-related adverse events
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Maximum measured concentration of the analyte in plasma after first dose (Cmax)
Time Frame
up to 24 hours after first dose
Title
Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)
Time Frame
up to 72 hours after last dose
Title
Time from first dosing to maximum measured concentration (Tmax)
Time Frame
up to 24 hours after first dose
Title
Time from last dosing to maximum measured concentration (Tmax,ss)
Time Frame
up to 72 hours after last dose
Title
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)
Time Frame
up to 24 hours after first dose
Title
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)
Time Frame
up to 72 hours after last dose
Title
Terminal half-life of the analyte in plasma after the first dose (t1/2)
Time Frame
up to 24 hours after first dose
Title
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time Frame
up to 72 hours after last dose
Title
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)
Time Frame
up to 72 hours after last dose
Title
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)
Time Frame
up to 72 hours after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1313.2.44001 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
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