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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 135585 XX; Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291732

1283.5

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

BI 135585 XX

Experimental group

Description:

single dose of BI 135585

Treatment:

Drug: BI 135585 XX

matching placebo

Placebo Comparator group

Description:

single dose of matching placebo

Treatment:

Drug: Matching placebo