- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651598
Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
October 31, 2013 updated by: Boehringer Ingelheim
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
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
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Manchester, United Kingdom
- 1313.2.44001 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 144807
Subjects receive multiple BID doses of BI 144807 solution
|
multiple dose (bid, low to high dose)
|
Placebo Comparator: Placebo
Subjects receive multiple BID doses of Placebo solution
|
multiple dose (bid)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number (% patients) of drug-related adverse events
Time Frame: up to 28 days
|
up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum measured concentration of the analyte in plasma after first dose (Cmax)
Time Frame: up to 24 hours after first dose
|
up to 24 hours after first dose
|
Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)
Time Frame: up to 72 hours after last dose
|
up to 72 hours after last dose
|
Time from first dosing to maximum measured concentration (Tmax)
Time Frame: up to 24 hours after first dose
|
up to 24 hours after first dose
|
Time from last dosing to maximum measured concentration (Tmax,ss)
Time Frame: up to 72 hours after last dose
|
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)
Time Frame: up to 24 hours after first dose
|
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)
Time Frame: up to 72 hours after last dose
|
up to 72 hours after last dose
|
Terminal half-life of the analyte in plasma after the first dose (t1/2)
Time Frame: up to 24 hours after first dose
|
up to 24 hours after first dose
|
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time Frame: up to 72 hours after last dose
|
up to 72 hours after last 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)
Time Frame: up to 72 hours after last 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)
Time Frame: up to 72 hours after last dose
|
up to 72 hours after last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
July 23, 2012
First Submitted That Met QC Criteria
July 25, 2012
First Posted (Estimate)
July 27, 2012
Study Record Updates
Last Update Posted (Estimate)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 31, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1313.2
- 2012-001615-23 (EudraCT Number: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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