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

NCT02642614 | Completed Phase 1 Results

• 2 other identifiers: 1320.162015-002123-25
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 10

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.

  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

Secondary Outcomes (7)

• Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period

  28 days

• 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.

• 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.

• 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.

• 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.

Study Arms (4)

BI 1026706 low dose

EXPERIMENTAL

Drug: BI 1026706; Drug: Placebo

BI 1026706 medium

EXPERIMENTAL

Drug: BI 1026706; Drug: Placebo

BI 1026706 high dose

EXPERIMENTAL

Drug: BI 1026706; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1026706 DRUG

BI 1026706 high dose; BI 1026706 low dose; BI 1026706 medium

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent consistent with ICH-Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial. Medication washout and medication restrictions are allowed only after signed informed consent is obtained.
• Males or females not of childbearing potential between 40 and 80 years (each inclusive) of age, on the day of patient´s signature of informed consent.
• All patients must have a documented diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD).
• Post-bronchodilator forced expiratory volume (FEV)1 of \>=40% and \<=90% of predicted normal at Visit 1
• Post-bronchodilator FEV1/forced vital capacity (FVC) \<70% at Visit 1
• Patients must be current or ex-smokers with a smoking history of more than 10 pack years
• Patients on stable respiratory medications for at least 6 weeks prior to randomization (Visit 3).
• Patients must be able to perform technically acceptable pulmonary function tests.

You may not qualify if:

• Significant pulmonary disease other than COPD or other medical conditions as determined by medical history, examination, and clinical investigations at screening that may, in the opinion of the investigator, result in the any of the following:
• Put the patient at risk because of participation in the study
• Influence the results of the study
• Cast doubt on the patients ability to participate in the study
• Patients with current asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
• Patients with a history of myocardial infarction or apoplexy within 6 months of the screening visit (Visit 1) or between the screening visit (Visit 1) and randomization.
• Patients with a history of and/or active life-threatening cardiac arrhythmia, as assessed by the investigator.
• Patients with a marked baseline prolongation of QT/QTcB interval (such as repeated demonstration of a QTcB interval \>450 ms), pulse/heart rate outside 50 to 90 bpm at Visit 1 (if confirmed by pulse rate measurement over 60 seconds), or any other relevant ECG finding.
• Patients with a history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome).
• Patients with known active tuberculosis.
• Patients with clinically relevant bronchiectasis, as assessed by the investigator.
• Patients with any respiratory infection (such as common cold, acute sinusitis, or similar illnesses) or COPD exacerbation within 6 weeks prior to the screening visit (Visit 1) or between the screening visit and randomization.
• Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed to participate.
• Patients with a history of and/or active significant alcohol or drug abuse as assessed by the investigator.
• Patients who are being treated with non-permitted concomitant medication.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

Bispebjerg og Frederiksberg Hospital

København NV, 2400, Denmark

Location

Odense University Hospital

Odense C, 5000, Denmark

Location

PAREXEL International GmbH

Berlin, 14050, Germany

Location

IKF Pneumologie GmbH & Co. KG

Frankfurt, 60596, Germany

Location

Inamed GmbH

Gauting, 82131, Germany

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Fraunhofer ITEM

Hanover, 30625, Germany

Location

KLB Gesundheitsforschung Lübeck GmbH

Lübeck, 23552, Germany

Location

Skånes universitetssjukhus, Lund

Lund, 221 85, Sweden

Location

The Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 30, 2015
• Study Start: January 25, 2016
• Primary Completion: June 14, 2016
• Study Completion: June 14, 2016
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-08

Locations

GB (1); DE (6); DK (2); SE (1)