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

Phase 1TerminatedNCT01207973

Boehringer Ingelheim36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis

Interventions

BI 113823DRUG

5 dose-groups of multiple oral doses of BI 113823

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria patients with osteoarthritis Exclusion criteria

Locations (1)

1272.2.1 Boehringer Ingelheim Investigational Site

München, Germany

Outcomes

Primary Outcomes

Safety (Physical examination)

Time frame: 15 days

Safety (Vital signs)

Time frame: 15 days

Safety (12-lead ECG)

Time frame: 15 days

Safety (Clinical laboratory tests)

Time frame: 15 days

Safety (Adverse Events)

Time frame: 15 days

Tolerability (Assessment of tolerability by investigator)

Time frame: 15 days

Secondary Outcomes

Measures of pharmacodynamic effects

Time frame: 15 days

Standard pharmacokinetic parameters for single dose and steady state conditions will be assessed

Time frame: 15 days

Data from ClinicalTrials.gov

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