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Completed

NCT Number: NCT01651598

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

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

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Key information

Conditions

Healthy Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1313.2.44001 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo to BI 144807

Drug

multiple dose (bid)

BI 144807

Drug

multiple dose (bid, low to high dose)

Primary outcomes

  1. Number (% patients) of drug-related adverse events

    Time frame: up to 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 27, 2012
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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