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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002369-39 | EudraCT Number | EudraCT |
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The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.
The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - Young Subjects | Placebo Comparator | Placebo - Young Subjects |
|
| Placebo - Elderly Subjects | Placebo Comparator | Placebo - Elderly Subjects |
|
| BI 409306 25 mg - Young Subjects QD | Experimental | 25 milligram (mg) of BI 409306 were administered in young subjects once daily (QD). |
|
| BI 409306 25 mg - Elderly Subjects QD | Experimental | 25 mg of BI 409306 were administered in elderly subjects once daily (QD). |
|
| BI 409306 50 mg - Young Subjects QD | Experimental | 50 mg of BI 409306 were administered in young subjects once daily (QD). |
|
| BI 409306 50 mg - Young Subjects BID | Experimental | 50 mg of BI 409306 were administered in young subjects twice daily (BID). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 409306 | Drug | Film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product. | From first drug administration until the end-of-trial examination, up to 28 days. |
| Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Number of participants with clinically relevant abnormal findings, as judged by investigator and reported as adverse event (AE), in vital signs (blood pressure, pulse rate, orthostatic test), 12-lead electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis) , physical examination, ophthalmological examination and suicidality assessment. | From first drug administration until the end-of-trial examination, up to 28 days. |
| Number of Participants Per Category of Global Tolerability Assessed by the Investigator | The investigator assessed tolerability based on adverse events and the laboratory evaluation and classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. Investigator judgement based on clinical findings: "good" - No or mild adverse events (AEs) and no clinically significant (NCS) findings in any clinical assessments; "satisfactory" - mild or moderate AEs, NCS clinical findings; "not satisfactory" - moderate/severe AEs and/or clinically significant (CS) findings. | From first drug administration until the end-of-trial examination, up to 28 days. |
| Number of Participants With Abnormal Findings in Color Discrimination Test | Color vision was tested using the Ishihara test for color deficiency. The test consisted of a number of plates, called Ishihara plates, each of which contains a circle of dots of differing color and size. Within the pattern some dots form a number visible to those with normal color vision and invisible, or difficult to see, for those with a color vision deficiency. Participants with abnormal findings in color discrimination test are participants, who are not able to recognize the sign on the presented table. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration of BI 409306 in Plasma (Cmax) | Maximum measured concentration of the BI 409306 in plasma after first dose. | On day 1, at -2:00 hours (pre dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose. |
| Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| 1289.2.1 Boehringer Ingelheim Investigational Site | Mannheim | 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. 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:
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All participants were screened for eligibility to participate in the trial. Participants attended a specialist sites which ensured that they met all of the inclusion and none of exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria was violated.
This is randomised, placebo control, double blind, phase 1, pharmacokinetic study in healthy young and elderly subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo- Young Subjects | Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2. |
| FG001 | Placebo-Elderly Subjects Once Daily (QD) | Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days. |
| FG002 | BI 409306 25 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. |
| FG003 | BI 409306 25 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. |
| FG004 | BI 409306 50 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. |
| FG005 | BI 409306 50 Milligram- Young Subjects (BID) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2). |
| FG006 | BI 409306 50 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. |
| FG007 | BI 409306 100 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. |
| FG008 | BI 409306 100 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set: Included all subjects who are treated with BI 409306.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo- Young Subjects | Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2. |
| BG001 | Placebo-Elderly Subjects Once Daily (QD) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years off all subjects in the study |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Maximum Concentration of BI 409306 in Plasma (Cmax) | Maximum measured concentration of the BI 409306 in plasma after first dose. | Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles/Litre (nmol/L) | On day 1, at -2:00 hours (pre dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose. |
|
From first drug administration until the end-of-trial examination, up to 28 days.
Treated set was used for analysis of adverse events data.
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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- Young Subjects | Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA 15.0 | 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 |
|---|---|
| C000630656 | BI 409306 |
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|
| BI 409306 50 mg - Elderly Subjects QD | Experimental | 50 mg of BI 409306 were administered in elderly subjects once daily |
|
| BI 409306 100 mg - Young Subjects QD | Experimental | 100 mg of BI 409306 were administered in young subjects once daily (QD). |
|
| BI 409306 100 mg - Elderly Subjects QD | Experimental | 100 mg of BI 409306 were administered in elderly subjects once daily (QD). |
|
| Placebo | Drug | Film-coated tablet |
|
| From first drug administration until the end-of-trial examination, up to 28 days. |
| Number of Participants With Abnormal Findings in Visual Acuity Test | Snellen chart was used to measure visual acuity. It measures the smallest line that a participant was able to read at a distance of 3 meter. Participants with abnormal findings in visual acuity test are participants, who are not able to recognize the letters on the line 3. | From first drug administration until the end-of-trial examination, up to 28 days. |
Time from dosing to maximum measured concentration of BI 409306 in plasma (Tmax) after the first dose. |
| On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose. |
| Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after first dose. | On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose. |
| Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) | Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval Ï„ after last dose. | At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment. |
| Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | Time from last dosing until the maximum concentration of the analyte in plasma is reached at steady state after last dose on day 14. | At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment. |
| Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCÏ„,ss) | This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval Ï„ after last dose on day 14. | At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment. |
| Other than specified |
|
Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days. |
| BG002 | BI 409306 25 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. |
| BG003 | BI 409306 25 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. |
| BG004 | BI 409306 50 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. |
| BG005 | BI 409306 50 Milligram- Young Subjects (BID) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2). |
| BG006 | BI 409306 50 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. |
| BG007 | BI 409306 100 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. |
| BG008 | BI 409306 100 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. |
| BG009 | Total | Total of all reporting groups |
Treated Set: Included all subjects who are treated with BI 409306.
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Gender distribution of all subjects in the study | Treated Set: Included all subjects who are treated with BI 409306. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of all included subjects in the study. Ethnicity data was not collected for this trial. | Treated Set: Included all subjects who are treated with BI 409306. | Count of Participants | Participants |
|
| OG001 | BI 409306 25 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. |
| OG002 | BI 409306 50 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. |
| OG003 | BI 409306 50 Milligram- Young Subjects (BID) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2). |
| OG004 | BI 409306 50 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. |
| OG005 | BI 409306 100 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. |
| OG006 | BI 409306 100 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. |
|
|
| Secondary | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | Time from dosing to maximum measured concentration of BI 409306 in plasma (Tmax) after the first dose. | Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics. | Posted | Median | Full Range | Hour (h) | On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 extrapolated to infinity after first dose. | Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole*Hour/Litre (nmol*h/L) | On day 1, at -2:00 hours (pre-dose) and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 hours after the first dose. |
|
|
|
| Secondary | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) | Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval Ï„ after last dose. | Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole/Litre (nmol/L) | At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment. |
|
|
|
| Secondary | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | Time from last dosing until the maximum concentration of the analyte in plasma is reached at steady state after last dose on day 14. | Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics. | Posted | Median | Full Range | Hour (h) | At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCÏ„,ss) | This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval Ï„ after last dose on day 14. | Pharmacokinetic Analysis Set (PKS): Included all subjects in the treated set who provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period (single dose or multiple dose segment) and had no important protocol violation relevant to the evaluation of pharmacokinetics. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole*Hour/Litre (nmol*h/L) | At 312:00 hours (pre dose) and at 312:10 , 312:20, 312:30, 312:45, 313:00, 313:30, 314:00, 314:30, 315:00, 316:00, 318:00, 320:00, 322:00, 324:00, 326:00, 336:00, 360:00, 384:00 hours post dose, for once daily and twice daily treatment. |
|
|
|
| Primary | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | An adverse event is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a subject in a clinical investigation who received a pharmaceutical product. | Treated Set (TS): Included all subjects who are treated with BI 409306. | Posted | Count of Participants | Participants | From first drug administration until the end-of-trial examination, up to 28 days. |
|
|
|
| Primary | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Number of participants with clinically relevant abnormal findings, as judged by investigator and reported as adverse event (AE), in vital signs (blood pressure, pulse rate, orthostatic test), 12-lead electrocardiogram (ECG), clinical laboratory tests (haematology, clinical chemistry, urinalysis) , physical examination, ophthalmological examination and suicidality assessment. | Treated Set (TS): Included all subjects who are treated with BI 409306. | Posted | Count of Participants | Participants | From first drug administration until the end-of-trial examination, up to 28 days. |
|
|
|
| Primary | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | The investigator assessed tolerability based on adverse events and the laboratory evaluation and classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. Investigator judgement based on clinical findings: "good" - No or mild adverse events (AEs) and no clinically significant (NCS) findings in any clinical assessments; "satisfactory" - mild or moderate AEs, NCS clinical findings; "not satisfactory" - moderate/severe AEs and/or clinically significant (CS) findings. | Treated Set (TS): Included all subjects who are treated with BI 409306. | Posted | Count of Participants | Participants | From first drug administration until the end-of-trial examination, up to 28 days. |
|
|
|
| Primary | Number of Participants With Abnormal Findings in Color Discrimination Test | Color vision was tested using the Ishihara test for color deficiency. The test consisted of a number of plates, called Ishihara plates, each of which contains a circle of dots of differing color and size. Within the pattern some dots form a number visible to those with normal color vision and invisible, or difficult to see, for those with a color vision deficiency. Participants with abnormal findings in color discrimination test are participants, who are not able to recognize the sign on the presented table. | Treated Set (TS): Included all subjects who are treated with BI 409306. | Posted | Count of Participants | Participants | From first drug administration until the end-of-trial examination, up to 28 days. |
|
|
|
| Primary | Number of Participants With Abnormal Findings in Visual Acuity Test | Snellen chart was used to measure visual acuity. It measures the smallest line that a participant was able to read at a distance of 3 meter. Participants with abnormal findings in visual acuity test are participants, who are not able to recognize the letters on the line 3. | Treated Set (TS): Included all subjects who are treated with BI 409306. | Posted | Count of Participants | Participants | From first drug administration until the end-of-trial examination, up to 28 days. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Placebo-Elderly Subjects Once Daily (QD) | Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG002 | BI 409306 25 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG003 | BI 409306 25 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. | 0 | 9 | 0 | 9 | 6 | 9 |
| EG004 | BI 409306 50 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. | 0 | 9 | 0 | 9 | 4 | 9 |
| EG005 | BI 409306 50 Milligram- Young Subjects (BID) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2). | 0 | 9 | 0 | 9 | 8 | 9 |
| EG006 | BI 409306 50 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG007 | BI 409306 100 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. | 0 | 9 | 0 | 9 | 8 | 9 |
| EG008 | BI 409306 100 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. | 0 | 9 | 0 | 9 | 8 | 9 |
| Abnormal sensation in eye | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Chromatopsia | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Withdrawal syndrome | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | 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.
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 12-lead ECG |
|
| Clinical laboratory test |
|
| Physical examiniation |
|
| Ophthalmological examination |
|
| Suicidality assessment |
|
| Satisfactory |
|
| Not satisfactory |
|
| Bad |
|
| Not assessable |
|