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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000052-34 | EudraCT Number | EudraCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Young subjects) | Placebo Comparator | Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days |
|
| BI 409306 - 25 milligram (mg) (Young subjects) | Experimental | Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days |
|
| BI 409306 - 50 milligram (mg) (Young subjects) | Experimental | Young healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days |
|
| Placebo (Elderly subjects) | Placebo Comparator | Elderly healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days |
|
| BI 409306 - 25 milligram (mg) (Elderly subjects) | Experimental | Elderly healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 409306 | Drug | Film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | Percentage of subjects with investigator defined drug-related Adverse Events (AEs). | 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 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. | From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) | 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 at Steady State (Cmax, ss) |
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Inclusion criteria:
1. Healthy male/female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1289.17.1 Boehringer Ingelheim Investigational Site | Neuss | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | 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 |
| FG005 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | BI 409306 - 25 Milligram (mg) (Young Subjects) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | As pre-specified in the protocol, the young and elderly subjects were analyzed separately. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Investigator Defined Drug-Related Adverse Events | Percentage of subjects with investigator defined drug-related Adverse Events (AEs). | The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment. | Posted | Number | Percentage of subjects | From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days |
|
From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days
The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment.
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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) | Young healthy subjects received placebo matching film-coated tablets of BI 409306 orally after an overnight fast once daily for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 15.1 | 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 milligram (mg) (Elderly subjects) | Experimental | Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days |
|
| Placebo | Drug | Elderly healthy subjects received 50 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days |
|
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. |
| 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). | 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 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). | 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 409306 in Plasma (Tmax) | 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 409306in Plasma at Steady State (Tmax,ss) | 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. |
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | Total | Total of all reporting groups |
Treated Set
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Treated Set | Count of Participants | Participants |
|
| Race (NIH/OMB) | Ethnicity was not reported in this trial | Treated Set | Count of Participants | Participants |
|
Young healthy subjects received 25 mg of BI 409306 film-coated tablets orally after an overnight fast once daily for 14 days |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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 |
| OG005 | 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 |
|
|
| Secondary | Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) | Maximum measured concentration of the BI 409306 in plasma (Cmax). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles per liter (nmol/L) | 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. |
|
|
|
| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles per liter (nmol/L) | 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. |
|
|
|
| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles*hour per liter (nmol*h/L) | 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. |
|
|
|
| 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). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles*hour per liter (nmol*h/L) | 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. |
|
|
|
| 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). | 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. | Posted | Median | Full Range | hours | 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. |
|
|
|
| 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). | 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. | Posted | Median | Full Range | hours | 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. |
|
|
|
| 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. | The treated set (TS) included all subjects who were randomised and documented to have taken at least one dose of investigational treatment. | Posted | Number | Percentage of subjects with findings | From the first administration of trial medication until 14 days after the last administration of trial medication, up to 28 days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | 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 | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | 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 | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | 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 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | 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 | 0 | 9 | 0 | 9 | 6 | 9 |
| EG005 | 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 | 0 | 9 | 0 | 9 | 5 | 9 |
| Chromatopsia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Eyelids pruritus | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Color discrimination test |
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| Suicidality assessment |
|
| Physical examination |
|
| Clinical laboratory tests |
|
| 12-lead electrocardiogram (ECG) |
|
| Blood pressure and pulse rate |
|
| Orthostatic intolerance |
|