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

Conditions

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

  • United Kingdom
      • 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
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)

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

Boehringer Ingelheim

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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