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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Placebo to BI 1026706; Drug: BI 1026706

• Registration Number: NCT02126826
• Lead Sponsor: Boehringer Ingelheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Study Start: 2014-05-28
• Primary Completion: 2014-10-01
• Study Completion: 2014-10-21
• Status Verified: 2018-12
• Results First Submitted: 2018-12-14
• Results First Submitted QC: 2018-12-14
• Last Update Submitted: 2018-12-14
• Results First Posted: 2019-03-25
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to BI 1026706	Placebo to BI 1026706	Multiple Rising Doses Placebo to BI 1026706
BI 1026706	BI 1026706	Multiple Rising Doses BI 1026706

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Drug Related Adverse Events	From first drug administration until 3 days after last drug administration, 15 days	Percentage of subjects with drug related adverse events (AEs)

Secondary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax)	1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin	Maximum measured concentration of the analyte in plasma (Cmax)
Time From Dosing to Maximum Measured Concentration (Tmax)	1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin.	Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)	1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24).
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)	1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12).
Maximum Measured Concentration at Steady-state (Cmax,ss)	5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12	Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval τ (Cmax,ss).
Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)	5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12	Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss).
Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)	5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12	Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ (AUCτ,ss).

Trial Locations

Locations (1)

1320.2.2 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany