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

NCT ID: NCT01480648

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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BI144807

Subjects receive a single oral dose of BI144807solution

Group Type EXPERIMENTAL

BI 144807

Intervention Type DRUG

single dose (low to high dose)

Placebo

Subjects receive a single oral dose of placebo solution

Group Type PLACEBO_COMPARATOR

BI 144807 Placebo

Intervention Type DRUG

Placebo that represents BI drug

Interventions

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BI 144807 Placebo

Placebo that represents BI drug

Intervention Type DRUG

BI 144807

single dose (low to high dose)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. healthy male subjects

Exclusion Criteria

1\. any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1313.1.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2011-002560-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1313.1

Identifier Type: -

Identifier Source: org_study_id