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Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers

NCT ID: NCT01347086

Last Updated: 2016-04-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.

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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 207127 NA (low dose)

Single dose of BI 207127 NA

Group Type EXPERIMENTAL

BI 207127 NA (low dose)

Intervention Type DRUG

single dose of BI 207127 NA

Matching placebo (low dose)

Single dose of matching placebo

Group Type PLACEBO_COMPARATOR

Matching placebo (low dose)

Intervention Type DRUG

single dose of matching placebo

BI 207127 NA (medium dose)

Single dose of BI 207127 NA

Group Type EXPERIMENTAL

BI 207127 NA (medium dose)

Intervention Type DRUG

Single does of BI 207127 NA

Matching placebo (medium dose)

Single dose of matching placebo

Group Type PLACEBO_COMPARATOR

Matching placebo (medium dose)

Intervention Type DRUG

Single dose of matching placebo

BI 207127 NA (high dose)

Single dose of BI 207127 NA

Group Type EXPERIMENTAL

BI 207127 NA (high dose)

Intervention Type DRUG

Single dose of BI 207127 NA

Matching placebo (high dose)

Single dose of matching placebo

Group Type PLACEBO_COMPARATOR

Matching placebo (high dose)

Intervention Type DRUG

Single dose of matching placebo

Interventions

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Matching placebo (low dose)

single dose of matching placebo

Intervention Type DRUG

BI 207127 NA (medium dose)

Single does of BI 207127 NA

Intervention Type DRUG

BI 207127 NA (low dose)

single dose of BI 207127 NA

Intervention Type DRUG

Matching placebo (medium dose)

Single dose of matching placebo

Intervention Type DRUG

BI 207127 NA (high dose)

Single dose of BI 207127 NA

Intervention Type DRUG

Matching placebo (high dose)

Single dose of matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteers
2. Chinese ethnicity or Japanese ethnicity or Caucasian
3. Body Mass Index (BMI) = 18.5 and BMI =25 kg/m2 for Japanese and Chinese, BMI =18.5 and BMI = 29.9 kg/m2 for Caucasians

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
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
Minimum Eligible Age

20 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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1241.8.8201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1241.8

Identifier Type: -

Identifier Source: org_study_id

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