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

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of Multiple Rising Oral Doses (50, 100, 200 and 350 mg qd and 100 mg Bid for 12 Days) of BI 113823 as Tablet in Male and Female Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01207973

Enrollment

Registered

2010-09-23

Start date

2010-09-30

Completion date

Unknown

Last updated

2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DRUGBI 113823

5 dose-groups of multiple oral doses of BI 113823

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

Inclusion criteria

patients with osteoarthritis

Design outcomes

Primary

Measure	Time frame
Tolerability (Assessment of tolerability by investigator)	15 days
Safety (Clinical laboratory tests)	15 days
Safety (Adverse Events)	15 days
Safety (Physical examination)	15 days
Safety (Vital signs)	15 days
Safety (12-lead ECG)	15 days

Secondary

Measure	Time frame
Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed	15 days
Measures of pharmacodynamic effects	15 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026