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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Matching placebo (medium dose); Drug: BI 207127 NA (high dose); Drug: Matching placebo (high dose); Drug: BI 207127 NA (medium dose); Drug: Matching placebo (low dose); Drug: BI 207127 NA (low dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01347086

1241.8

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 6 patient groups, including a placebo group

BI 207127 NA (low dose)

Experimental group

Description:

Single dose of BI 207127 NA

Treatment:

Drug: BI 207127 NA (low dose)

Matching placebo (low dose)

Placebo Comparator group

Description:

Single dose of matching placebo

Treatment:

Drug: Matching placebo (low dose)

BI 207127 NA (medium dose)

Experimental group

Description:

Single dose of BI 207127 NA

Treatment:

Drug: BI 207127 NA (medium dose)

Matching placebo (medium dose)

Placebo Comparator group

Description:

Single dose of matching placebo

Treatment:

Drug: Matching placebo (medium dose)

BI 207127 NA (high dose)

Experimental group

Description:

Single dose of BI 207127 NA

Treatment:

Drug: BI 207127 NA (high dose)

Matching placebo (high dose)

Placebo Comparator group

Description:

Single dose of matching placebo

Treatment:

Drug: Matching placebo (high dose)