Healthy
Conditions
Brief summary
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy young and elderly male and female volunteers following oral administration of repeated rising doses, given once daily over 14 days to young healthy genotyped and elderly healthy male/female volunteers.
Interventions
DRUGBI 409306
Film-coated tablet
DRUGPlacebo
Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Healthy male/female subjects
Exclusion criteria
1\. Any relevant deviation from healthy conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days | Percentage of subjects with investigator defined drug-related Adverse Events (AEs). |
| Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days | Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24) | PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration. | Area under the concentration-time curve of the BI 409306 in plasma from 0 to 24 hours (AUC0-24). |
| Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration. | Area under the concentration-time curve of the BI 409306 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss). |
| Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) | PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration. | Maximum measured concentration of the BI 409306 in plasma (Cmax). |
| Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss) | PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration. | Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss). |
| Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax) | PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration. | Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (tmax). |
| Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss) | PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration. | Maximum measured concentration of the BI 409306 in plasma at steady state (Cmax, ss). |
Countries
Germany
Participant flow
Recruitment details
Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BI 409306 film-coated tablets given orally once daily (q.d.) for 14 days in young and elderly healthy male/female volunteers (randomized, double-blind, placebo controlled within dose groups Phase I study).All young subjects were Poor Metabolizer for CYP2C19
Pre-assignment details
All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be entered to trial if any one of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Young Subjects) Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days | 4 |
| BI 409306 - 25 Milligram (mg) (Young Subjects) Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days | 6 |
| BI 409306 - 50 Milligram (mg) (Young Subjects) Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days | 6 |
| Placebo (Elderly Subjects) Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days | 6 |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days | 9 |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days | 9 |
| Total | 40 |
Baseline characteristics
| Characteristic | BI 409306 - 50 Milligram (mg) (Elderly Subjects) | BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Placebo (Elderly Subjects) | Total | Placebo (Young Subjects) | BI 409306 - 50 Milligram (mg) (Young Subjects) | BI 409306 - 25 Milligram (mg) (Young Subjects) |
|---|---|---|---|---|---|---|---|
| Age, Continuous Elderly subjects | 68.1 Years STANDARD_DEVIATION 2.4 | 69.9 Years STANDARD_DEVIATION 3.1 | 70.8 Years STANDARD_DEVIATION 3.4 | 69.5 Years STANDARD_DEVIATION 3.1 | — | — | — |
| Age, Continuous Young subjects | — | — | — | 30.5 Years STANDARD_DEVIATION 8.7 | 23.8 Years STANDARD_DEVIATION 3 | 30.8 Years STANDARD_DEVIATION 10.2 | 34.7 Years STANDARD_DEVIATION 7.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 14 Participants | 4 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 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 |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 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 |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 6 Participants | 26 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 2 Participants | 17 Participants | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 4 Participants | 23 Participants | 1 Participants | 4 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 2 / 4 | 3 / 6 | 3 / 6 | 4 / 6 | 6 / 9 | 5 / 9 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests
Percentage of subjects with clinically relevant abnormalities in Vital signs,12-lead electrocardiogram (ECG), Clinical laboratory tests (hematology, clinical chemistry, and urinalysis), Physical examination, Suicidality assessment, Color discrimination test, Visual acuity test.
Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Population: The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Visual acuity test | 0.0 Percentage of subjects with findings |
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Suicidality assessment | 0.0 Percentage of subjects with findings |
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Orthostatic intolerance | 25.0 Percentage of subjects with findings |
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Physical examination | 0.0 Percentage of subjects with findings |
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Clinical laboratory tests | 0.0 Percentage of subjects with findings |
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Blood pressure and pulse rate | 0.0 Percentage of subjects with findings |
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | 12-lead electrocardiogram (ECG) | 25.0 Percentage of subjects with findings |
| Placebo (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Color discrimination test | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Visual acuity test | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Clinical laboratory tests | 16.6 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | 12-lead electrocardiogram (ECG) | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Color discrimination test | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Blood pressure and pulse rate | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Suicidality assessment | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Orthostatic intolerance | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Physical examination | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | 12-lead electrocardiogram (ECG) | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Blood pressure and pulse rate | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Clinical laboratory tests | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Visual acuity test | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Physical examination | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Color discrimination test | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Orthostatic intolerance | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Suicidality assessment | 0.0 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Blood pressure and pulse rate | 0.0 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Orthostatic intolerance | 33.3 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Color discrimination test | 0.0 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Suicidality assessment | 0.0 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Physical examination | 0.0 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Clinical laboratory tests | 0.0 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Visual acuity test | 0.0 Percentage of subjects with findings |
| Placebo (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | 12-lead electrocardiogram (ECG) | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Physical examination | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Blood pressure and pulse rate | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | 12-lead electrocardiogram (ECG) | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Visual acuity test | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Suicidality assessment | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Color discrimination test | 0.0 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Orthostatic intolerance | 33.3 Percentage of subjects with findings |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Clinical laboratory tests | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Orthostatic intolerance | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Visual acuity test | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Color discrimination test | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Physical examination | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Clinical laboratory tests | 11.1 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | 12-lead electrocardiogram (ECG) | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Blood pressure and pulse rate | 0.0 Percentage of subjects with findings |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Clinically Relevant Abnormalities for Different Tests | Suicidality assessment | 0.0 Percentage of subjects with findings |
Primary
Percentage of Subjects With Investigator Defined Drug-Related Adverse Events
Percentage of subjects with investigator defined drug-related Adverse Events (AEs).
Time frame: From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
Population: The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Young Subjects) | Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | 50.0 Percentage of subjects |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | 50.0 Percentage of subjects |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | 66.7 Percentage of subjects |
| Placebo (Elderly Subjects) | Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | 50.0 Percentage of subjects |
| BI 409306 - 25 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | 55.6 Percentage of subjects |
| BI 409306 - 50 Milligram (mg) (Elderly Subjects) | Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | 44.4 Percentage of subjects |
Secondary
Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of the BI 409306 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss).
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Young Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | 1800 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 29.7 |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | 3410 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 40.8 |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | 682 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 58.9 |
| Placebo (Elderly Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | 1250 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 50.1 |
Secondary
Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24)
Area under the concentration-time curve of the BI 409306 in plasma from 0 to 24 hours (AUC0-24).
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Young Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24) | 1570 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 33.5 |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24) | 2690 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 50.2 |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24) | 622 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 72.6 |
| Placebo (Elderly Subjects) | Area Under the Concentration-time Curve of the BI 409306 in Plasma From 0 to 24 Hours (AUC0-24) | 1030 Nanomoles*hour per liter (nmol*h/L) | Geometric Coefficient of Variation 42.1 |
Secondary
Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss)
Maximum measured concentration of the BI 409306 in plasma at steady state (Cmax, ss).
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Young Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss) | 694 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 33.1 |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss) | 1740 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 29.8 |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss) | 516 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 51.2 |
| Placebo (Elderly Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma at Steady State (Cmax, ss) | 872 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 56.3 |
Secondary
Maximum Measured Concentration of the BI 409306 in Plasma (Cmax)
Maximum measured concentration of the BI 409306 in plasma (Cmax).
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Young Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) | 679 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 44.1 |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) | 1310 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 33.9 |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) | 459 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 55.2 |
| Placebo (Elderly Subjects) | Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) | 768 Nanomoles per liter (nmol/L) | Geometric Coefficient of Variation 55.3 |
Secondary
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss)
Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss).
Time frame: PK blood samples were taken at 312, 312.167, 312.333, 312.5, 312.75, 313, 313.5, 314, 314.5, 315, 316, 318, 320, 322, 324, 326, 336, 360, 384 hours after drug administration.
Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo (Young Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss) | 0.634 hours |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss) | 0.417 hours |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss) | 0.333 hours |
| Placebo (Elderly Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306in Plasma at Steady State (Tmax,ss) | 0.367 hours |
Secondary
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax)
Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (tmax).
Time frame: PK blood samples were taken at 0, 0.167, 0.333, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours after drug administration.
Population: The pharmacokinetics (PK) set included all subjects in the treated set with at least 1 evaluable observation for a PK endpoint in at least 1 treatment period and no important protocol violations relevant to the PK evaluation. All subjects in the treated set who received active drug were included in the PK set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo (Young Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax) | 0.625 hours |
| BI 409306 - 25 Milligram (mg) (Young Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax) | 0.750 hours |
| BI 409306 - 50 Milligram (mg) (Young Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax) | 0.500 hours |
| Placebo (Elderly Subjects) | Time From Dosing to the Maximum Concentration of the BI 409306 in Plasma (Tmax) | 0.500 hours |