Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee

Phase 1

Terminated

• Conditions: Osteoarthritis
• Interventions: Drug: BI 113823

• 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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-09-22
• Study First Posted: 2010-09-23
• Primary Completion: 2011-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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 (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
Safety (Clinical laboratory tests)	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