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Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects

NCT ID: NCT01195688

Last Updated: 2011-06-02

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

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses

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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 638683

1 single dose per subject as oral solution

Group Type EXPERIMENTAL

BI 638683 or placebo

Intervention Type DRUG

oral doses given to 6 subjects per dose group

Placebo solution

1 single dose per subject as oral solution

Group Type PLACEBO_COMPARATOR

Placebo solution

Intervention Type DRUG

oral doses given to 2 subjects per dose group

Interventions

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BI 638683 or placebo

oral doses given to 6 subjects per dose group

Intervention Type DRUG

Placebo solution

oral doses given to 2 subjects per dose group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

healthy male subjects
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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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1279.1.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-021187-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1279.1

Identifier Type: -

Identifier Source: org_study_id

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