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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001107-71 | EudraCT Number |
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The primary objective of this trial is to investigate the safety and tolerability of BI 1265162 in healthy male subjects following inhalative administration of multiple rising doses.
Secondary objectives is the exploration of the pharmacokinetics (PK) including dose proportionality and time dependency of BI 1265162 after multiple dosing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1265162 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1265162 | Drug | Multiple rising inhaled doses |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events (AEs) | Percentage of participants with drug-related adverse events (AEs). | From first drug administration until 2 days after last drug administration, up to 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the BI 1265162 in Plasma Over the Time Interval of 0 to 12 Hour (h) After Administration of the First Dose (AUC0-12) | Area under the concentration-time curve of the BI 1265162 in plasma over the time interval of 0 to 12 hour (h) after administration of the first dose (AUC0-12). | Pharmacokinetic samples were taken within 1:30 hour:minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20 , 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after dosing on day 1. |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:
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All participants were screened for eligibility to participate in the trial. Participants attended a specialist site which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
This Multiple rising dose (MRD) trial was designed as double-blind, randomised, and placebo-controlled within parallel dose groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching BI 1265162 | Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily. |
| FG001 | 10 Microgram (μg) BI 1265162 | Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily. |
| FG002 | 30 μg BI 1265162 | Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily. |
| FG003 | 100 μg BI 1265162 | Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily. |
| FG004 | 300 μg BI 1265162 | Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily. |
| FG005 | 600 μg BI 1265162 | Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): The TS included included all participants who received at least 1 dose of trial drug. This was the full analysis set population in the sense of International council for harmonisation - efficacy guideline 9: statistical principles for clinical trials (ICH-E9).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching BI 1265162 | Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Drug-related Adverse Events (AEs) | Percentage of participants with drug-related adverse events (AEs). | Treated set (TS): The TS included included all participants who received at least 1 dose of trial drug. This was the full analysis set population in the sense of International council for harmonisation - efficacy guideline 9: statistical principles for clinical trials (ICH-E9). | Posted | Number | Percentage of participants (%) | From first drug administration until 2 days after last drug administration, up to 10 days. |
|
From first drug administration until 2 days after last drug administration, up to 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Matching BI 1265162 | Participants were administered single and multiple dose of placebo matching BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), placebo matching BI 1265162 was administered twice daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2018 | Dec 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2019 | Dec 17, 2021 | SAP_001.pdf |
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| Drug |
Multiple rising inhaled doses |
|
| Maximum Measured Concentration of the BI 1265162 in Plasma After Administration of the First Dose (Cmax) | Maximum measured concentration of the BI 1265162 in plasma after administration of the first dose (Cmax). | Pharmacokinetic samples were taken within 1:30 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00, 12:00 and 24:00 h:m after dosing on day 1. |
| Area Under the Concentration-time Curve of the BI 1265162 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of the BI 1265162 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). | Pharmacokinetic samples were taken 0:05 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after last dosing on day 8. |
| Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss). | Pharmacokinetic samples were taken 0:05 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after last dosing on day 8. |
| BG001 |
| 10 Microgram (μg) BI 1265162 |
Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily. |
| BG002 | 30 μg BI 1265162 | Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily. |
| BG003 | 100 μg BI 1265162 | Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily. |
| BG004 | 300 μg BI 1265162 | Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily. |
| BG005 | 600 μg BI 1265162 | Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 10 Microgram (μg) BI 1265162 | Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily. |
| OG002 | 30 μg BI 1265162 | Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily. |
| OG003 | 100 μg BI 1265162 | Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily. |
| OG004 | 300 μg BI 1265162 | Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily. |
| OG005 | 600 μg BI 1265162 | Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily. |
|
|
| Secondary | Area Under the Concentration-time Curve of the BI 1265162 in Plasma Over the Time Interval of 0 to 12 Hour (h) After Administration of the First Dose (AUC0-12) | Area under the concentration-time curve of the BI 1265162 in plasma over the time interval of 0 to 12 hour (h) after administration of the first dose (AUC0-12). | Pharmacokinetic parameter set (PKS): This subject set included all subjects in the TS who provided at least 1 PK parameter that was not excluded because of protocol deviations relevant to the statistical evaluation of Pharmacokinetic (PK) endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomoles*Hour Per Litre (pmol*h/L) | Pharmacokinetic samples were taken within 1:30 hour:minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20 , 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after dosing on day 1. |
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| Secondary | Maximum Measured Concentration of the BI 1265162 in Plasma After Administration of the First Dose (Cmax) | Maximum measured concentration of the BI 1265162 in plasma after administration of the first dose (Cmax). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomoles Per Litre (pmol/L) | Pharmacokinetic samples were taken within 1:30 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00, 12:00 and 24:00 h:m after dosing on day 1. |
|
|
|
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| Secondary | Area Under the Concentration-time Curve of the BI 1265162 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of the BI 1265162 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomoles*Hour Per Litre (pmol*h/L) | Pharmacokinetic samples were taken 0:05 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after last dosing on day 8. |
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|
|
| Secondary | Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss). | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Picomoles Per Litre (pmol/L) | Pharmacokinetic samples were taken 0:05 hour: minute (h:m) before dosing and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 8:00 and 12:00 h:m after last dosing on day 8. |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | 10 Microgram (μg) BI 1265162 | Participants were administered single and multiple dose of 10 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 10 μg BI 1265162 was administered twice daily. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG002 | 30 μg BI 1265162 | Participants were administered single and multiple dose of 30 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 30 μg BI 1265162 was administered twice daily. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | 100 μg BI 1265162 | Participants were administered single and multiple dose of 100 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 100 μg BI 1265162 was administered twice daily. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG004 | 300 μg BI 1265162 | Participants were administered single and multiple dose of 300 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 300 μg BI 1265162 was administered twice daily. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG005 | 600 μg BI 1265162 | Participants were administered single and multiple dose of 600 μg BI 1265162 solution for inhalation orally via Respimat® A5 inhaler. On days 1 and 8 participant received a single dose in the morning only. On all other trial days (Days 2 to 7), 600 μg BI 1265162 was administered twice daily. | 0 | 8 | 0 | 8 | 2 | 8 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Oral mucosal erythema | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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| Other |
| Other |
| Other |