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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005652-26 | EudraCT Number | EudraCT |
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To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 425809 5 mg | Experimental | Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days. |
|
| BI 425809 10 mg | Experimental | Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days. |
|
| BI 425809 25 mg | Experimental | Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days. |
|
| BI 425809 50 mg | Experimental | Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 425809 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14). | 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809. |
| Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14) | Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14). | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809. |
| Maximum Measured Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809. | 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description). |
| Maximum Measured Concentration of BI 425809 in CSF (Cmax) | Maximum measured concentration of BI 425809 in CSF is reported. | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809. |
| Concentration of BI 425809 in Plasma at the Time Point 312h (C312) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events (AEs) | Percentage of participants with drug-related adverse events (AEs). | From the first drug administration until 11 days after the last drug administration, up to 30days. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1346.3.32001 Boehringer Ingelheim Investigational Site | Antwerp | Belgium |
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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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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 applied a non-randomised, open label, sequential-group, multiple-dose design. Participants were allocated to 4 dose groups of 6 participants each. Each participant was treated once daily for 14 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 425809 5 mg | Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days. |
| FG001 | BI 425809 10 mg | Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days. |
| FG002 | BI 425809 25 mg | Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days. |
| FG003 | BI 425809 50 mg | Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 425809 5 mg | Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days. |
| BG001 | BI 425809 10 mg | Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days. |
| 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 | Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) | Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14). | The PK analysis set (PKS) included all subjects from the Treated Set (TS) who provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole*hours/Liter (nmol∙h/L) | 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809. |
|
From the first drug administration until 11 days after the last drug administration, up to 30 days.
Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug.
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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 | BI 425809 5 mg | Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 18.0 | 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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| ID | Term |
|---|---|
| C000634404 | BI 425809 |
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Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.
| 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809. |
| Concentration of BI 425809 in CSF at the Time Point 312h (C312) | Concentration of BI 425809 in CSF at the time point 312h (C312) is reported. | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809. |
| Withdrawal by Subject |
|
| BG002 | BI 425809 25 mg | Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days. |
| BG003 | BI 425809 50 mg | Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | BI 425809 10 mg | Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days. |
| OG002 | BI 425809 25 mg | Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days. |
| OG003 | BI 425809 50 mg | Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days. |
|
|
|
| Primary | Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14) | Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14). | PKS. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol∙h/L | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809. |
|
|
|
|
| Primary | Maximum Measured Concentration of BI 425809 in Plasma (Cmax) | Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809. | PKS. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/L) | 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description). |
|
|
|
|
| Primary | Maximum Measured Concentration of BI 425809 in CSF (Cmax) | Maximum measured concentration of BI 425809 in CSF is reported. | PKS. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809. |
|
|
|
|
| Primary | Concentration of BI 425809 in Plasma at the Time Point 312h (C312) | Concentration of BI 425809 in plasma at the time point 312h (C312) is reported. | PKS. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809. |
|
|
|
|
| Primary | Concentration of BI 425809 in CSF at the Time Point 312h (C312) | Concentration of BI 425809 in CSF at the time point 312h (C312) is reported. | PKS. Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809. |
|
|
|
|
| Secondary | Percentage of Participants With Drug-related Adverse Events (AEs) | Percentage of participants with drug-related adverse events (AEs). | Treated set: all subjects from the entered set (ES) who were documented to have received at least 1 dose of study drug. | Posted | Number | Percentage of participants | From the first drug administration until 11 days after the last drug administration, up to 30days. |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | BI 425809 10 mg | Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days. | 0 | 6 | 5 | 6 |
| EG002 | BI 425809 25 mg | Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days. | 0 | 8 | 8 | 8 |
| EG003 | BI 425809 50 mg | Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days. | 0 | 5 | 4 | 5 |
| Gingivitis | Infections and infestations | 18.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | 18.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 18.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | 18.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | 18.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | 18.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | 18.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | 18.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 18.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 18.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 18.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | 18.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | 18.0 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | 18.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | 18.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | 18.0 | 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.