Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: BI 1026706; Drug: Placebo

• Registration Number: NCT02642614
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-30
• Study Start: 2016-01-25
• Primary Completion: 2016-06-14
• Study Completion: 2016-06-14
• Results First Submitted: 2018-12-12
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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
BI 1026706 low dose	BI 1026706	-
BI 1026706 high dose	Placebo	-
BI 1026706 medium	BI 1026706	-
BI 1026706 medium	Placebo	-
BI 1026706 high dose	BI 1026706	-
Placebo	Placebo	-
BI 1026706 low dose	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.	From first drug administration until 4 days after last drug administration, up to 32 days	Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period.

Secondary Outcome Measures

Name	Time	Method
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28)	-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.	Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax, ss) after the last dose (morning of Day 28)
Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period	28 days	Change in Absolute Number of Neutrophil in Sputum at the end of the planned treatment period
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1)	-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.	Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax) after the first dose (morning of Day 1)
Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1)	-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.	Area under the concentration-time curve of BI 1026706 in plasma (AUC 0-12h) after the first dose (morning of Day 1)
Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28)	-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.	Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau (Cmax, ss) after the last dose (morning of Day 28)
Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1)	-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.	Maximum measured concentration of BI 1026706 in plasma (Cmax) after the first dose (morning of Day 1)
Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28)	-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.	Area under the concentration-time curve of BI 1026706 in plasma at steady state over a uniform dosing interval tau (AUC tau, ss) after the last dose (morning of Day 28)

Trial Locations

Locations (10)

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH; 🇩🇪 Großhansdorf, Germany

Fraunhofer ITEM; 🇩🇪 Hannover, Germany

Skånes universitetssjukhus, Lund; 🇸🇪 Lund, Sweden

Odense University Hospital; 🇩🇰 Odense C, Denmark

IKF Pneumologie GmbH & Co. KG; 🇩🇪 Frankfurt, Germany

PAREXEL International GmbH; 🇩🇪 Berlin, Germany

Bispebjerg og Frederiksberg Hospital; 🇩🇰 København NV, Denmark

Inamed GmbH; 🇩🇪 Gauting, Germany

The Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

KLB Gesundheitsforschung Lübeck GmbH; 🇩🇪 Lübeck, Germany