At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Matching placebo (low dose) +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses (400mg, 800mg, 1200mg) of BI 207127 NA in Healthy Male Asian Volunteers and Single Oral Dose (1200 mg) of BI 207127 NA in Healthy Male Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Group)
In Brief
A Phase 1 clinical trial evaluating Matching placebo (low dose), BI 207127 NA (medium dose), and 4 other interventions for Healthy. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and Caucasian healthy male volunteers administered BI 207127 NA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMay 2011
Primary CompletionJun 2011
TodayJul 2026
First PostedMay 4, 2011
Enrollment StartMay 1, 2011
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.2 years ago
Interventions
Matching placebo (low dose)drug
single dose of matching placebo
BI 207127 NA (medium dose)drug
Single does of BI 207127 NA
BI 207127 NA (low dose)drug
single dose of BI 207127 NA
Matching placebo (medium dose)drug
Single dose of matching placebo
BI 207127 NA (high dose)drug
Single dose of BI 207127 NA
Matching placebo (high dose)drug
Single dose of matching placebo