Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of BI 11634 Oral Solution in Healthy Male Volunteers
NCT02214940 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2014-08-13
Summary
First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in a statistical sense defined)
Conditions
- Healthy
Interventions
- DRUG
-
BI 11634
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2007-09-30
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