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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects

NCT ID: NCT01629849

Last Updated: 2013-05-16

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-12-31

Brief Summary

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To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects

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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 1021958 qd

Multiple rising dose

Group Type EXPERIMENTAL

BI 1021958 qd

Intervention Type DRUG

tablet

Placebo to BI 1021958 qd

Matching placebo as tablets

Group Type PLACEBO_COMPARATOR

Placebo to BI 1021958 qd

Intervention Type DRUG

tablet

BI 1021958 bid

Multiple rising dose

Group Type EXPERIMENTAL

BI 1021958 bid

Intervention Type DRUG

tablets

Placebo to BI 1021958 bid

Matching palcebo as tablet

Group Type PLACEBO_COMPARATOR

Placebo to BI 1021958 bid

Intervention Type DRUG

tablets

Interventions

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Placebo to BI 1021958 qd

tablet

Intervention Type DRUG

BI 1021958 bid

tablets

Intervention Type DRUG

Placebo to BI 1021958 bid

tablets

Intervention Type DRUG

BI 1021958 qd

tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Healthy male and female subjects ofn non child-bearing potential

Exclusion Criteria

1\. Any relevant deviation from healthy conditions except mild controlled asthma
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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1310.2.1 Boehringer Ingelheim Investigational Site

Gauting, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-000926-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1310.2

Identifier Type: -

Identifier Source: org_study_id

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