Safety Tolerability and Pharmacokinetic of BI 411034
NCT01581684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2017-08-15
Summary
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.
The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).
Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
Conditions
- Healthy
Interventions
- DRUG
-
BI 411034
Low dose solution for oral administration
- DRUG
-
Solution for oral administration
- DRUG
-
BI 411034
Medium dose solution for oral administration
- DRUG
-
BI 411034
Low dose solution for oral administration
- DRUG
-
BI 411034
High dose solution for oral administration
- DRUG
-
BI 411034
High dose solution for oral administration
- DRUG
-
BI 411034
Medium dose solution for oral administration
- DRUG
-
BI 411034
High dose solution for oral administration
- DRUG
-
BI 411034
Medium dose solution for oral administration
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-04-01
- Primary Completion
- 2012-08-01
- Completion
- 2012-08-01
Countries
- Germany
Study Locations
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