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Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

NCT ID: NCT01681277

Last Updated: 2017-01-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-05-31

Brief Summary

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The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 113608 high dose bid

powder in the bottle for oral solution, oral administration with 240 ml water

Group Type EXPERIMENTAL

Placebo to BI 113608 PIB bid

Intervention Type DRUG

powder for oral solution

BI 113608 PIB bid

Intervention Type DRUG

powder for oral solution

BI 113608 low dose bid

powder in the bottle for oral solution, oral administration with 240 ml water

Group Type EXPERIMENTAL

Placebo to BI 113608 PIB bid

Intervention Type DRUG

powder for oral solution

BI 113608 PIB bid

Intervention Type DRUG

powder for oral solution

BI 113608 medium dose bid

powder in the bottle for oral solution, oral administration with 240 ml water

Group Type EXPERIMENTAL

BI 113608 PIB bid

Intervention Type DRUG

powder for oral solution

Placebo to BI 113608 PIB bid

Intervention Type DRUG

powder for oral solution

BI 113608 high dose qd

powder in the bottle for oral solution, oral administration with 240 ml water

Group Type EXPERIMENTAL

Placebo to BI 113608 PIB qd

Intervention Type DRUG

powder for oral solution

BI 113608 PIB qd

Intervention Type DRUG

powder for oral solution

Interventions

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BI 113608 PIB bid

powder for oral solution

Intervention Type DRUG

Placebo to BI 113608 PIB bid

powder for oral solution

Intervention Type DRUG

Placebo to BI 113608 PIB bid

powder for oral solution

Intervention Type DRUG

Placebo to BI 113608 PIB qd

powder for oral solution

Intervention Type DRUG

Placebo to BI 113608 PIB bid

powder for oral solution

Intervention Type DRUG

BI 113608 PIB bid

powder for oral solution

Intervention Type DRUG

BI 113608 PIB bid

powder for oral solution

Intervention Type DRUG

BI 113608 PIB qd

powder for oral solution

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

50 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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Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-002536-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1314.2

Identifier Type: -

Identifier Source: org_study_id

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