Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX
NCT01587391 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2013-10-31
Summary
To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range
Conditions
- Healthy
Interventions
- DRUG
-
Placebo to BI 163538 XX
1 single dose per subject as oral solution
- DRUG
-
BI 163538 XX
1 single dose per subject as oral solution
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2012-10-31
- Completion
- 2012-10-31
Countries
- Germany
Study Locations
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