Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01651598
Collaborator
(none)
57
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6
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Study Details
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
Study Design
Study Type:
Interventional
Actual Enrollment
:
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Jul 1, 2012
Actual Primary Completion Date
:
Jan 1, 2013
Actual Study Completion Date
:
Jan 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BI 144807 Subjects receive multiple BID doses of BI 144807 solution |
Drug: BI 144807
multiple dose (bid, low to high dose)
|
| Placebo Comparator: Placebo Subjects receive multiple BID doses of Placebo solution |
Drug: Placebo to BI 144807
multiple dose (bid)
|
Outcome Measures
Primary Outcome Measures
- Number (% patients) of drug-related adverse events [up to 28 days]
Secondary Outcome Measures
- 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]
- Time from first dosing to maximum measured concentration (Tmax) [up to 24 hours after first dose]
- 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]
- 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 after the first dose (t1/2) [up to 24 hours after first dose]
- Terminal half-life of the analyte in plasma at steady state (t1/2,ss) [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) [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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
- mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)
Exclusion criteria:
- Apart from mild asthma any relevant deviation from healthy conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1313.2.44001 Boehringer Ingelheim Investigational Site | Manchester | United Kingdom |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01651598
Other Study ID Numbers:
- 1313.2
- 2012-001615-23
First Posted:
Jul 27, 2012
Last Update Posted:
Nov 1, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms: