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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 144807; Drug: BI 144807 Placebo

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1313.1.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BI144807; Subjects receive a single oral dose of BI144807solution	Drug: BI 144807; single dose (low to high dose)
PLACEBO_COMPARATOR: Placebo; Subjects receive a single oral dose of placebo solution	Drug: BI 144807 Placebo; Placebo that represents BI drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 24, 2011
• First Posted (ESTIMATE): November 29, 2011

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

• Other Study ID Numbers: 1313.1; 2011-002560-24 (EUDRACT_NUMBER: EudraCT)