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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee

NCT02126826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-03-25

Study results available
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Summary

* To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses
* To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients
* The assessment of pharmacodynamics in OA patients

Conditions

Interventions

DRUG

BI 1026706

Multiple Rising Doses (oral solution, tablet)

DRUG

Placebo to BI 1026706

Multiple Rising Doses (oral solution / tablet, identical to active treatment)

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-28
Primary Completion
2014-10-01
Completion
2014-10-21

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126826 on ClinicalTrials.gov