NCT01480648

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

November 21, 2011

Last Update Submit

October 31, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • All adverse events

    up to 14 days postdose

  • Number of participants with clinically significant changes in vital signs

    up to 14 days postdose

  • Number of participants with clinically significant changes in ECG

    up to 14 days postdose

  • Number of participants with clinically significant changes in laboratory tests

    up to 14 days postdose

  • Number of participants with clinically significant changes in physical examination

    up to 14 days postdose

  • Number of participants tolerating BI 144807

    up to 14 days postdose

Secondary Outcomes (5)

  • Cmax (maximum measured concentration of the analyte in plasma)

    up to 72h postdose

  • tmax (time from dosing to maximum measured concentration)

    up to 72h postdose

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

    up to 72h postdose

  • 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)

    up to 72h postdose

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

    up to 72h postdose

Study Arms (2)

BI144807

EXPERIMENTAL

Subjects receive a single oral dose of BI144807solution

Drug: BI 144807

Placebo

PLACEBO COMPARATOR

Subjects receive a single oral dose of placebo solution

Drug: BI 144807 Placebo

Interventions

BI 144807 PlaceboDRUG

Placebo that represents BI drug

Placebo
BI 144807DRUG

single dose (low to high dose)

BI144807

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. healthy male subjects

You may not qualify if:

  • \. any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1313.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 29, 2011

Study Start

November 1, 2011

Primary Completion

February 1, 2012

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

DE(1)