Multiple dose escalation study in a multicenter, randomized, single-blind, parallel-group, placebo-controlled design to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of BAY 1213790 administered subcutaneously in healthy male subjects.
Completed
- Conditions
- Veneuze trombo-embolie.Venous thromboembolism
- Registration Number
- NL-OMON46278
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
white healthy male
18 - 55 years
weight less then 115 kilograms
BMI 18 - 29.9 kilograms/meter2
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study. Donation of more than 100 mL of whole blood or plasma within 4 weeks or 500 mL whole blood within 3 months before study drug administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the safety and tolerability of BAY 1213790 administered<br /><br>subcutaneously as a single loading dose followed by multiple maintenance doses<br /><br>in healthy male subjects by means of frequency of TEAEs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the PK of BAY 1213790 in plasma after multiple subcutaneous<br /><br>doses</p><br>