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Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.

NCT ID: NCT01291732

Last Updated: 2013-11-01

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Brief Summary

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The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.

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 135585 XX

single dose of BI 135585

Group Type EXPERIMENTAL

BI 135585 XX

Intervention Type DRUG

single dose of low, medium or high dose of BI 135585 XX

matching placebo

single dose of matching placebo

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type DRUG

single dose of matching placebo

Interventions

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Matching placebo

single dose of matching placebo

Intervention Type DRUG

BI 135585 XX

single dose of low, medium or high dose of BI 135585 XX

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteers,
2. Chinese or Japanese ethnicity

Exclusion Criteria

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
Minimum Eligible Age

20 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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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1283.5.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1283.5

Identifier Type: -

Identifier Source: org_study_id