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Safety of Single Rising Doses and Relative Bioavailability of BI 691751

NCT ID: NCT01843972

Last Updated: 2016-06-27

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

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

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To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

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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

SINGLE

Study Groups

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BI 691751 dose 2 (part I)

single dose given as oral solution

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

oral solution BI 691751, dose 2

BI 691751 dose 3 (part I)

single dose given as oral solution

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

oral solution BI 691751, dose 3

BI 691751 dose 4 (part I)

single dose given as oral solution

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

oral solution BI 69175, dose 4

BI 691751 dose 5 (part I)

single dose given as oral solution

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

oral solution BI 691751, dose 5

BI 691751 dose 6 (part I)

single dose given as oral solution

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

oral solution BI 691751, dose 6

BI 691751 dose 7 (part I)

single dose given as oral solution

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

oral solution BI 691751, dose 7

BI 691751dose 1 (part I)

single dose given as oral solution

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

oral solution BI 69175, dose 1

Placebo (part I)

placebo solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo solution

BI 691751 tablet (part II)

single dose given as 1 tablet

Group Type EXPERIMENTAL

BI 691751

Intervention Type DRUG

1 tablet

BI 691751 solution (part II)

single dose given as oral solution

Group Type ACTIVE_COMPARATOR

BI 691751

Intervention Type DRUG

oral solution

Interventions

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BI 691751

oral solution BI 691751, dose 6

Intervention Type DRUG

BI 691751

oral solution

Intervention Type DRUG

Placebo

placebo solution

Intervention Type DRUG

BI 691751

oral solution BI 691751, dose 2

Intervention Type DRUG

BI 691751

oral solution BI 691751, dose 5

Intervention Type DRUG

BI 691751

1 tablet

Intervention Type DRUG

BI 691751

oral solution BI 691751, dose 3

Intervention Type DRUG

BI 691751

oral solution BI 69175, dose 4

Intervention Type DRUG

BI 691751

oral solution BI 691751, dose 7

Intervention Type DRUG

BI 691751

oral solution BI 69175, dose 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subjects
2. Subjects must be able to understand and comply with study requirements
3. Age from 18 to 55 years
4. BMI range: from 18.5 to 29.9 kg/m2
5. Known genotype as specified in the study protocol

Exclusion Criteria

1\. Any relevant deviation from healthy conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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1334.1.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-005721-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1334.1

Identifier Type: -

Identifier Source: org_study_id

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