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First in Man Trial of BI 113608

NCT ID: NCT01540825

Last Updated: 2017-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-05-31

Brief Summary

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The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 113608 high dose 1

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

High dose powder for oral solution

BI 113608 low dose 1

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

Low dose powder for oral solution

BI 113608 low dose 2

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

Low dose powder for oral solution

BI 113608 low dose 4

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

Low dose powder for oral solution

BI 113608 low dose 5

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

Low dose powder for oral solution

BI 113608 medium dose 1

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

Medium dose powder for oral solution

BI 113608 medium dose 2

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

Medium dose powder for oral solution

BI 113608 medium dose 3

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

Medium dose powder for oral solution

BI 113608 high dose 2

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

High dose powder for oral solution

BI 113608 high dose 3

Powder for oral solution

Group Type EXPERIMENTAL

BI 113608

Intervention Type DRUG

High dose powder for oral solution

Placebo

Powder for oral solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Powder for oral solution

Interventions

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BI 113608

Low dose powder for oral solution

Intervention Type DRUG

BI 113608

High dose powder for oral solution

Intervention Type DRUG

BI 113608

Medium dose powder for oral solution

Intervention Type DRUG

BI 113608

Low dose powder for oral solution

Intervention Type DRUG

Placebo

Powder for oral solution

Intervention Type DRUG

BI 113608

Low dose powder for oral solution

Intervention Type DRUG

BI 113608

High dose powder for oral solution

Intervention Type DRUG

BI 113608

High dose powder for oral solution

Intervention Type DRUG

BI 113608

Medium dose powder for oral solution

Intervention Type DRUG

BI 113608

Medium dose powder for oral solution

Intervention Type DRUG

BI 113608

Low dose 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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2011-005034-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1314.1

Identifier Type: -

Identifier Source: org_study_id

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