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

NCT ID: NCT01651598

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 144807

Subjects receive multiple BID doses of BI 144807 solution

Group Type EXPERIMENTAL

BI 144807

Intervention Type DRUG

multiple dose (bid, low to high dose)

Placebo

Subjects receive multiple BID doses of Placebo solution

Group Type PLACEBO_COMPARATOR

Placebo to BI 144807

Intervention Type DRUG

multiple dose (bid)

Interventions

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Placebo to BI 144807

multiple dose (bid)

Intervention Type DRUG

BI 144807

multiple dose (bid, low to high dose)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. mild asthmatic, otherwise healthy subjects (male and female of non-childbearing potential)

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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1313.2.44001 Boehringer Ingelheim Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2012-001615-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1313.2

Identifier Type: -

Identifier Source: org_study_id

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