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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

NCT01347086 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-04-15

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

Matching placebo (low dose)

single dose of matching placebo

DRUG

BI 207127 NA (medium dose)

Single does of BI 207127 NA

DRUG

BI 207127 NA (low dose)

single dose of BI 207127 NA

DRUG

Matching placebo (medium dose)

Single dose of matching placebo

DRUG

BI 207127 NA (high dose)

Single dose of BI 207127 NA

DRUG

Matching placebo (high dose)

Single dose of matching placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347086 on ClinicalTrials.gov