Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee
- Registration Number
- NCT01207973
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the study is to investigate the safety and tolerability of BI 113823 in male and female patients with osteoarthritis, following oral administration of BI 113823 with repeated rising doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BI 113823 BI 113823 5 dose-groups of multiple oral doses of BI 113823
- Primary Outcome Measures
Name Time Method Safety (Clinical laboratory tests) 15 days Safety (Physical examination) 15 days Safety (Vital signs) 15 days Safety (12-lead ECG) 15 days Safety (Adverse Events) 15 days Tolerability (Assessment of tolerability by investigator) 15 days
- Secondary Outcome Measures
Name Time Method Measures of pharmacodynamic effects 15 days Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed 15 days
Trial Locations
- Locations (1)
1272.2.1 Boehringer Ingelheim Investigational Site
🇩🇪Muenchen, Germany
1272.2.1 Boehringer Ingelheim Investigational Site🇩🇪Muenchen, Germany