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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000805-60 | EudraCT Number |
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In both parts, the primary comparisons of interest are between the percentage of patients with drug-related adverse events at each dose and placebo during single and multiple dosing regimens. Based on these, the primary trial objective is to assess safety and tolerability of BI 894416 at each dose.
Secondary measures of interest are the geometric means of BI 894416 plasma AUC0-∞ and Cmax after single dose in SRD part and AUC0-8 and Cmax after single dose as well as AUCτ,ss and Cmax,ss after 7 days multiple dosing in MRD part. The objective is to assess the pharmacokinetics of BI 894416 following single and multiple administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRD part: Placebo | Placebo Comparator | Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
|
| SRD part: 75 mg BI 894416 | Experimental | Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
|
| SRD part: 125 mg BI 894416 | Experimental | Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
|
| SRD part: 170 mg BI 894416 | Experimental | Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
|
| MRD part: Placebo | Placebo Comparator | Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 894416 | Drug | BI 894416 film-coated tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Treatment-emergent Adverse Events Related to BI 894416 | Percentage of patients with treatment-emergent adverse events (AEs) related to BI 894416. | From start of treatment till the end of trial, up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) of BI 894416 (SRD Part) | AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 894416 (single rising dose part). | 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraunhofer ITEM | Hanover | 30625 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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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). For more details refer to: http://trials.boehringer-ingelheim.com/
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
The trial was randomised, placebo-controlled within groups, and single blinded. The trial consisted of a single rising dose (SRD) and a multiple rising dose (MRD) part. Last follow-up visit occurred between 14 and 16 days after the single dose for the SRD part and between day 14 and 21 days after the last dose for the MRD part.
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| ID | Title | Description |
|---|---|---|
| FG000 | SRD Part: Placebo | Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| FG001 | SRD Part: 75 mg BI 894416 | Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| FG002 | SRD Part: 125 mg BI 894416 | Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| FG003 | SRD Part: 170 mg BI 894416 | Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| FG004 | MRD Part: Placebo | Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| FG005 | MRD Part: 10 mg BI 894416 | Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| FG006 | MRD Part: 25 mg BI 894416 | Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| FG007 | MRD Part: 50 mg BI 894416 | Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| FG008 | MRD Part: 60 mg BI 894416 | Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
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| ID | Title | Description |
|---|---|---|
| BG000 | SRD Part: Placebo | Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| BG001 | SRD Part: 75 mg BI 894416 |
| 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 Patients With Treatment-emergent Adverse Events Related to BI 894416 | Percentage of patients with treatment-emergent adverse events (AEs) related to BI 894416. | Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received. | Posted | Number | Percentage of participants | From start of treatment till the end of trial, up to 30 days. |
|
From start of treatment till the end of trial, up to 30 days.
Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received.
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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 | SRD Part: Placebo | Single rising dose (SRD) part: Placebo film-coated tablet matching BI 894416 taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
The planned last two dose level in the single rising dose (SRD) part and the last dose in the multiple rising dose (MRD) part were not used as the predicted exposure exceeded the limits predefined in the clinical trial protocol.
| 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 | Oct 14, 2020 | Sep 9, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2021 | Sep 9, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| MRD part: 10 mg BI 894416 | Experimental | Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
|
| MRD part: 25 mg BI 894416 | Experimental | Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
|
| MRD part: 50 mg BI 894416 | Experimental | Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
|
| MRD part: 60 mg BI 894416 | Experimental | Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
|
| Placebo | Drug | Placebo film-coated tablet matching BI 894416. |
|
| Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 (SRD Part) | Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 (single rising dose part). | 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment. |
| AUC0-8 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 8 Hours) of BI 894416 After the First Dose (MRD Part) | AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) of BI 894416 after the first dose (Multiple rising dose part). | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours following first dose (day 1). |
| Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 After the First Dose (MRD Part) | Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 after the first dose (Multiple rising dose part). | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23.92 hours following first dose (day 1). |
| AUCtau,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part) | AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part). | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9). |
| Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part) | Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part). | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9). |
| Difference From Baseline in Airway Resistance (RAW) After 7 Days of Treatment (MRD Part) | Difference in airway resistance (RAW) from baseline (measured on day 1) to day 9, after 7 days (day 2-8) of t.i.d. (three times daily) treatment. | Up to 9 days. |
Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours.
| BG002 | SRD Part: 125 mg BI 894416 | Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| BG003 | SRD Part: 170 mg BI 894416 | Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| BG004 | MRD Part: Placebo | Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| BG005 | MRD Part: 10 mg BI 894416 | Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| BG006 | MRD Part: 25 mg BI 894416 | Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| BG007 | MRD Part: 50 mg BI 894416 | Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| BG008 | MRD Part: 60 mg BI 894416 | Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| BG009 | 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 |
|
Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| OG002 | SRD Part: 125 mg BI 894416 | Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| OG003 | SRD Part: 170 mg BI 894416 | Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| OG004 | MRD Part: Placebo | Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| OG005 | MRD Part: 10 mg BI 894416 | Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| OG006 | MRD Part: 25 mg BI 894416 | Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| OG007 | MRD Part: 50 mg BI 894416 | Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| OG008 | MRD Part: 60 mg BI 894416 | Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. |
| OG009 | SRD Part: Total BI 894416 | Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg). |
| OG010 | SRD Part: Total (BI 894416 and Placebo) | Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo). |
| OG011 | MRD Part: Total BI 894416 | Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg). |
| OG012 | MRD Part: Total (BI 894416 and Placebo) | Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo). |
|
|
| Secondary | AUC0-∞ (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) of BI 894416 (SRD Part) | AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 894416 (single rising dose part). | Pharmacokinetic set (PKS): the PKS includes all patients in the TS who provided at least one pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles*hours/liter | 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment. |
|
|
|
| Secondary | Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 (SRD Part) | Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 (single rising dose part). | Pharmacokinetic set (PKS): the PKS includes all patients in the TS who provided at least one pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles/liter | 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following treatment. |
|
|
|
| Secondary | AUC0-8 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 8 Hours) of BI 894416 After the First Dose (MRD Part) | AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 8 hours) of BI 894416 after the first dose (Multiple rising dose part). | Pharmacokinetic set (PKS): the PKS includes all patients in the TS who provided at least one pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles*hours/liter | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours following first dose (day 1). |
|
|
|
| Secondary | Cmax (Maximum Measured Concentration of the Analyte in Plasma) of BI 894416 After the First Dose (MRD Part) | Cmax (maximum measured concentration of the analyte in plasma) of BI 894416 after the first dose (Multiple rising dose part). | Pharmacokinetic set (PKS): the PKS includes all patients in the TS who provided at least one pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles/liter | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23.92 hours following first dose (day 1). |
|
|
|
| Secondary | AUCtau,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part) | AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part). | Pharmacokinetic set (PKS): the PKS includes all patients in the TS who provided at least one pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles*hours/liter | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9). |
|
|
|
| Secondary | Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State) of BI 894416 After the Last Dose (MRD Part) | Cmax,ss (maximum measured concentration of the analyte in plasma at steady state) of BI 894416 after the last dose (Multiple rising dose part). | Pharmacokinetic set (PKS): the PKS includes all patients in the TS who provided at least one pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics, or due to pharmacokinetic non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles/liter | 5 minutes before and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following last dose (day 9). |
|
|
|
| Secondary | Difference From Baseline in Airway Resistance (RAW) After 7 Days of Treatment (MRD Part) | Difference in airway resistance (RAW) from baseline (measured on day 1) to day 9, after 7 days (day 2-8) of t.i.d. (three times daily) treatment. | Treated set (TS): the TS includes all patients who were randomised and treated with at least one dose of trial medication. The treatment assignment was determined based on the 1st treatment the patient received. The TS was used for safety analyses. | Posted | Mean | Standard Deviation | kilopascal/liter/second | Up to 9 days. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | SRD Part: 75 mg BI 894416 | Single rising dose (SRD) part: 75 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG002 | SRD Part: 125 mg BI 894416 | Single rising dose (SRD) part: 125 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG003 | SRD Part: 170 mg BI 894416 | Single rising dose (SRD) part: 170 milligram (mg) BI 894416 film-coated tablet taken once orally with 240 milliliter of water after an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG004 | MRD Part: Placebo | Multiple rising dose (MRD) part: Placebo film-coated tablet matching BI 894416 taken for 9 days orally with 240 milliliter of water. Administration of Placebo at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG005 | MRD Part: 10 mg BI 894416 | Multiple rising dose (MRD) part: 10 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG006 | MRD Part: 25 mg BI 894416 | Multiple rising dose (MRD) part: 25 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG007 | MRD Part: 50 mg BI 894416 | Multiple rising dose (MRD) part: 50 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG008 | MRD Part: 60 mg BI 894416 | Multiple rising dose (MRD) part: 60 milligram (mg) BI 894416 film-coated tablet taken for 9 days orally with 240 milliliter of water. Administration of BI 894416 at Day 1 and Day 9 once daily in the morning (q.d.) and at Day 2 to Day 8 three times daily at an interval of 8 hours (t.i.d.). Morning dose to be taken after an overnight fast of at least 10 hours, afternoon dose to be taken after fasting for 2 hours. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG009 | SRD Part: Total BI 894416 | Single rising dose (SRD) part, total of all subjects treated with BI 894416 (75 mg, 125 mg and 170 mg). | 0 | 23 | 0 | 23 | 17 | 23 |
| EG010 | SRD Part: Total (BI 894416 and Placebo) | Single rising dose (SRD) part, total of all subjects in SRD part (75 mg, 125 mg 170 mg and placebo). | 0 | 29 | 0 | 29 | 18 | 29 |
| EG011 | MRD Part: Total BI 894416 | Multiple rising dose (MRD) part, total of all subjects treated with BI 894416 (10 mg, 25 mg, 50 mg and 60 mg). | 0 | 31 | 0 | 31 | 24 | 31 |
| EG012 | MRD Part: Total (BI 894416 and Placebo) | Multiple rising dose (MRD) part, total of all subjects in MRD part (10 mg, 25 mg, 50 mg, 60 mg and placebo). | 0 | 39 | 0 | 39 | 30 | 39 |
| EG013 | Total BI 894416 | All subjects treated with BI 894416 in either the single rising dose or multiple rising dose part. | 0 | 54 | 0 | 54 | 41 | 54 |
| EG014 | Total | All subjects in the study. | 0 | 68 | 0 | 68 | 48 | 68 |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Medical device site pruritus | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Sluggishness | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Mite allergy | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Eyelid infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 23.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Anxiety disorder | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Bladder pain | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.1 | 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.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |