Healthy
Conditions
Brief summary
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
Interventions
DRUGBI 409306
Film-coated tablet
DRUGPlacebo
Film-coated tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests 2. Age \>21 and Age \<50 years for young healthy volunteers or Age \>65 and Age \<80 years for elderly healthy volunteers 3. BMI \>18.5 and BMI \<29.9 kg/m2 (Body Mass Index) 4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation. 5. For female subjects: Female subjects must be surgically sterilized or postmenopausal. Surgical sterilization or hysterectomy must have occurred at least 6 months prior to screening. Menopausal women must have no regular menstrual bleeding for at least 2 years prior to screening.
Exclusion criteria
1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance 2. Any evidence of a clinically relevant concomitant disease 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. Surgery of the gastrointestinal tract (except appendectomy) 5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders) 6. History or evidence of relevant orthostatic reaction (drop in systolic blood pressure (SBP) \>20 mm Hg and increase in heart rate \> 30 bpm after 2 minutes standing relative to supine data), fainting spells or blackouts. 7. Chronic or relevant acute infections 8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) 9. Intake of any drugs within 14 days or drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial 10. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial 11. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial 12. Smoker (\> 5 cigarettes or \> 1 cigars or \> 1 pipes/day) 13. Inability to refrain from smoking on trial days 14. Alcohol abuse (more than 20 g/day) 15. Drug abuse 16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial) 17. Excessive physical activities (within one week prior to administration or during the trial) 18. Any laboratory value outside the reference range that is of clinical relevance in the judgment of investigator 19. Inability to comply with dietary regimen of trial site 20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc F interval \>430 ms in males and \>450 ms in females); 21. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | From first drug administration until the end-of-trial examination, up to 28 days. | 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. |
| Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | From first drug administration until the end-of-trial examination, up to 28 days. | 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. |
| Number of Participants Per Category of Global Tolerability Assessed by the Investigator | From first drug administration until the end-of-trial examination, up to 28 days. | 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. |
| Number of Participants With Abnormal Findings in Color Discrimination Test | From first drug administration until the end-of-trial examination, up to 28 days. | 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. |
| Number of Participants With Abnormal Findings in Visual Acuity Test | From first drug administration until the end-of-trial examination, up to 28 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration of BI 409306 in Plasma (Cmax) | 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 measured concentration of the BI 409306 in plasma after first dose. |
| Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 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. | This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose on day 14. |
| Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 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) 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-∞) | 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 after first dose. |
| Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 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. | Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose. |
| Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 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 from last dosing until the maximum concentration of the analyte in plasma is reached at steady state after last dose on day 14. |
Countries
Germany
Participant flow
Recruitment details
This is randomised, placebo control, double blind, phase 1, pharmacokinetic study in healthy young and elderly subjects.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Placebo-Elderly Subjects Once Daily (QD) Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days. | 9 |
| 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. | 9 |
| 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. | 9 |
| 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. | 9 |
| 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). | 9 |
| 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. | 8 |
| 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. | 9 |
| 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. | 9 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other than specified | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | BI 409306 50 Milligram- Elderly Subjects (QD) | BI 409306 25 Milligram- Elderly Subjects (QD) | Placebo-Elderly Subjects Once Daily (QD) | BI 409306 100 Milligram- Elderly Subjects (QD) | Total | BI 409306 25 Milligram- Young Subjects (QD) | Placebo- Young Subjects | BI 409306 100 Milligram- Young Subjects (QD) | BI 409306 50 Milligram- Young Subjects (BID) | BI 409306 50 Milligram- Young Subjects (QD) |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Elderly Subjects | 70.5 Years STANDARD_DEVIATION 4 | 69.1 Years STANDARD_DEVIATION 3.1 | 67.6 Years STANDARD_DEVIATION 3 | 67.9 Years STANDARD_DEVIATION 3.6 | 68.7 Years STANDARD_DEVIATION 3.5 | — | — | — | — | — |
| Age, Continuous Young Subjects | — | — | — | — | 42.0 Years STANDARD_DEVIATION 7.6 | 42.2 Years STANDARD_DEVIATION 6.6 | 41.8 Years STANDARD_DEVIATION 9.7 | 42.2 Years STANDARD_DEVIATION 6.3 | 41.9 Years STANDARD_DEVIATION 7.9 | 42.1 Years STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 9 Participants | 9 Participants | 82 Participants | 9 Participants | 12 Participants | 9 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 7 Participants | 3 Participants | 36 Participants | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants | 6 Participants | 47 Participants | 7 Participants | 8 Participants | 7 Participants | 6 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 6 / 12 | 3 / 9 | 5 / 9 | 6 / 9 | 4 / 9 | 8 / 9 | 5 / 8 | 8 / 9 | 8 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 |
Outcome results
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.
Time frame: From first drug administration until the end-of-trial examination, up to 28 days.
Population: Treated Set (TS): Included all subjects who are treated with BI 409306.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 1 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 11 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 9 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 9 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 9 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 9 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 9 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 8 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 9 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not assessable | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Bad | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Not satisfactory | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Good | 8 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants Per Category of Global Tolerability Assessed by the Investigator | Satisfactory | 1 Participants |
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.
Time frame: From first drug administration until the end-of-trial examination, up to 28 days.
Population: Treated Set (TS): Included all subjects who are treated with BI 409306.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 1 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Color Discrimination Test | 0 Participants |
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.
Time frame: From first drug administration until the end-of-trial examination, up to 28 days.
Population: Treated Set (TS): Included all subjects who are treated with BI 409306.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Abnormal Findings in Visual Acuity Test | 1 Participants |
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.
Time frame: From first drug administration until the end-of-trial examination, up to 28 days.
Population: Treated Set (TS): Included all subjects who are treated with BI 409306.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Suicidality assessment | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Ophthalmological examination | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Vital signs | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Physical examiniation | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | Clinical laboratory test | 0 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Participants With Clinically Relevant Abnormal Findings in Vital Signs, 12-lead ECG, Clinical Laboratory Tests, Physical Examination, Ophthalmological Examination and Suicidality Assessment | 12-lead ECG | 0 Participants |
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.
Time frame: From first drug administration until the end-of-trial examination, up to 28 days.
Population: Treated Set (TS): Included all subjects who are treated with BI 409306.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 6 Participants |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 3 Participants |
| BI 409306 50 Milligram- Young Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 5 Participants |
| BI 409306 50 Milligram- Young Subjects (BID) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 6 Participants |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 4 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 8 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 5 Participants |
| BI 409306 100 Milligram- Young Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 8 Participants |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Number of Young and Elderly Subjects With On-treatment Adverse Events by Treatment Group | 8 Participants |
Secondary
Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss)
This endpoint calculates area under the concentration-time curve of BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose on day 14.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 747 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 93.1 |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 621 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 55.8 |
| BI 409306 50 Milligram- Young Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 1070 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 125 |
| BI 409306 50 Milligram- Young Subjects (BID) | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 1100 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 52.4 |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 1710 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 83.6 |
| BI 409306 100 Milligram- Young Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 1960 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 64.3 |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma at Steady State (AUCτ,ss) | 3990 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 119 |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 548 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 142 |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 594 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 48.6 |
| BI 409306 50 Milligram- Young Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 955 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 97.6 |
| BI 409306 50 Milligram- Young Subjects (BID) | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1140 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 54 |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1510 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 70.5 |
| BI 409306 100 Milligram- Young Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 1620 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 60.1 |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 2840 Nanomole*Hour/Litre (nmol*h/L) | Geometric Coefficient of Variation 56.1 |
Secondary
Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Maximum measured concentration of the BI 409306 in plasma at steady state over a uniform dosing interval τ after last dose.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 348 Nanomole/Litre (nmol/L) | Geometric Coefficient of Variation 71.4 |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 444 Nanomole/Litre (nmol/L) | Geometric Coefficient of Variation 44.2 |
| BI 409306 50 Milligram- Young Subjects (QD) | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 663 Nanomole/Litre (nmol/L) | Geometric Coefficient of Variation 98 |
| BI 409306 50 Milligram- Young Subjects (BID) | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 596 Nanomole/Litre (nmol/L) | Geometric Coefficient of Variation 42.8 |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 1250 Nanomole/Litre (nmol/L) | Geometric Coefficient of Variation 76.6 |
| BI 409306 100 Milligram- Young Subjects (QD) | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 1260 Nanomole/Litre (nmol/L) | Geometric Coefficient of Variation 55.4 |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Maximum Concentration of BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | 2150 Nanomole/Litre (nmol/L) | Geometric Coefficient of Variation 87 |
Secondary
Maximum Concentration of BI 409306 in Plasma (Cmax)
Maximum measured concentration of the BI 409306 in plasma after first dose.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Maximum Concentration of BI 409306 in Plasma (Cmax) | 245 Nanomoles/Litre (nmol/L) | Geometric Coefficient of Variation 130 |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Maximum Concentration of BI 409306 in Plasma (Cmax) | 376 Nanomoles/Litre (nmol/L) | Geometric Coefficient of Variation 48 |
| BI 409306 50 Milligram- Young Subjects (QD) | Maximum Concentration of BI 409306 in Plasma (Cmax) | 565 Nanomoles/Litre (nmol/L) | Geometric Coefficient of Variation 84.6 |
| BI 409306 50 Milligram- Young Subjects (BID) | Maximum Concentration of BI 409306 in Plasma (Cmax) | 696 Nanomoles/Litre (nmol/L) | Geometric Coefficient of Variation 47.8 |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Maximum Concentration of BI 409306 in Plasma (Cmax) | 1100 Nanomoles/Litre (nmol/L) | Geometric Coefficient of Variation 58.5 |
| BI 409306 100 Milligram- Young Subjects (QD) | Maximum Concentration of BI 409306 in Plasma (Cmax) | 1030 Nanomoles/Litre (nmol/L) | Geometric Coefficient of Variation 79.2 |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Maximum Concentration of BI 409306 in Plasma (Cmax) | 1840 Nanomoles/Litre (nmol/L) | Geometric Coefficient of Variation 68.1 |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 0.750 Hour (h) |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 0.500 Hour (h) |
| BI 409306 50 Milligram- Young Subjects (QD) | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 0.500 Hour (h) |
| BI 409306 50 Milligram- Young Subjects (BID) | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 0.750 Hour (h) |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 0.333 Hour (h) |
| BI 409306 100 Milligram- Young Subjects (QD) | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 0.500 Hour (h) |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Time From Dosing to Maximum Measured Concentration of BI 409306 in Plasma (Tmax) | 0.500 Hour (h) |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 0.750 Hour (h) |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 0.500 Hour (h) |
| BI 409306 50 Milligram- Young Subjects (QD) | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 0.625 Hour (h) |
| BI 409306 50 Milligram- Young Subjects (BID) | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 0.750 Hour (h) |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 0.417 Hour (h) |
| BI 409306 100 Milligram- Young Subjects (QD) | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 0.500 Hour (h) |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Time to Achieve Maximum Concentration of BI 409306 in Plasma at Steady State (Tmax,ss) | 0.333 Hour (h) |