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Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

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ClinicalTrials.gov Identifier: NCT01651598
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Healthy Asthma Drug: Placebo to BI 144807 Drug: BI 144807 Phase 1

Study Type : Interventional  (Clinical Trial)
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 : July 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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)



Primary Outcome Measures :
  1. Number (% patients) of drug-related adverse events [ Time Frame: up to 28 days ]

Secondary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma after first dose (Cmax) [ Time Frame: up to 24 hours after first dose ]
  2. Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss) [ Time Frame: up to 72 hours after last dose ]
  3. Time from first dosing to maximum measured concentration (Tmax) [ Time Frame: up to 24 hours after first dose ]
  4. Time from last dosing to maximum measured concentration (Tmax,ss) [ Time Frame: up to 72 hours after last dose ]
  5. 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 ]
  6. 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 ]
  7. Terminal half-life of the analyte in plasma after the first dose (t1/2) [ Time Frame: up to 24 hours after first dose ]
  8. Terminal half-life of the analyte in plasma at steady state (t1/2,ss) [ Time Frame: up to 72 hours after last dose ]
  9. 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 ]
  10. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651598


Locations
United Kingdom
1313.2.44001 Boehringer Ingelheim Investigational Site
Manchester, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01651598     History of Changes
Other Study ID Numbers: 1313.2
2012-001615-23 ( EudraCT Number: EudraCT )
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013