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Completed

NCT Number: NCT01480648

Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers

This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1313.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy male subjects

Exclusion criteria

  • any relevant deviation from healthy conditions

Treatment and study plan

BI 144807 Placebo

Drug

Placebo that represents BI drug

BI 144807

Drug

single dose (low to high dose)

Primary outcomes

  1. All adverse events

    Time frame: up to 14 days postdose

  2. Number of participants with clinically significant changes in vital signs

    Time frame: up to 14 days postdose

  3. Number of participants with clinically significant changes in ECG

    Time frame: up to 14 days postdose

  4. Number of participants with clinically significant changes in laboratory tests

    Time frame: up to 14 days postdose

  5. Number of participants with clinically significant changes in physical examination

    Time frame: up to 14 days postdose

  6. Number of participants tolerating BI 144807

    Time frame: up to 14 days postdose

Secondary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 72h postdose

  2. tmax (time from dosing to maximum measured concentration)

    Time frame: up to 72h postdose

  3. AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Time frame: up to 72h postdose

  4. AUC(0-tz) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

    Time frame: up to 72h postdose

  5. t1/2 (terminal half-life of the analyte in plasma)

    Time frame: up to 72h postdose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 144807 Powder in Bottle (1 to 1200 mg) in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Trial

Important dates

Study start
2011
Primary completion
2012
First posted
Nov 29, 2011
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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