At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 98 enrolled
Drug / intervention
BI 113608 +7 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 and Multiple Rising Oral Doses of BI 113608 in Healthy Male Asian and Caucasian Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
In Brief
A Phase 1 clinical trial evaluating BI 113608 and Placebo for Healthy. Completed, enrolled 98 participants across 1 site.
Detailed Summary
Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedAug 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedAug 14, 2013
Enrollment StartAug 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.9 years ago
Interventions
BI 113608drug
Medium dose (Multiple dosing)
Placebodrug
Placebo (Multiple dosing)
BI 113608drug
Low dose (Multiple dosing)
Placebodrug
Placebo (Single dosing)
BI 113608drug
High dose (Single dosing)
BI 113608drug
Medium dose (Single dosing)
BI 113608drug
Low dose (Single dosing)
BI 113608drug
High dose (Multiple dosing)