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To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706

NCT ID: NCT01763333

Last Updated: 2019-03-25

Study Results

Results available

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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

2013-01-08

Study Completion Date

2013-09-04

Brief Summary

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To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706

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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

SINGLE

Study Groups

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1 BI 1026706 single rising dose part

single rising doses of BI 1026706

Group Type EXPERIMENTAL

BI 1026706 Placebo

Intervention Type DRUG

Placebo to BI 1026706

BI 1026706

Intervention Type DRUG

different dose formulations

2 BI 1026706 bioavailability part

bioavailability part of BI 1026706

Group Type EXPERIMENTAL

BI 1026706

Intervention Type DRUG

different dose formulations

Interventions

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BI 1026706 Placebo

Placebo to BI 1026706

Intervention Type DRUG

BI 1026706

different dose formulations

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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1320.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-002366-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1320.1

Identifier Type: -

Identifier Source: org_study_id

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