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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004840-23 | EudraCT Number | EudraCT |
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The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.
The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).
Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 411034 low dose - group 1 | Experimental | Solution for oral administration |
|
| BI 411034 low dose - group 2 | Experimental | Solution for oral administration |
|
| BI 411034 medium dose - group 3 | Experimental | Solution for oral administration |
|
| BI 411034 medium dose - group 4 | Experimental | Solution for oral administration |
|
| BI 411034 medium dose - group 5 | Experimental | Solution for oral administration |
|
| BI 411034 high dose - group 6 | Experimental | Solution for oral administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 411034 | Drug | Low dose solution for oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug Related AEs | Number of participants with drug related adverse events (AEs) | From drug administration until end of trial examination, up to 13 days |
| Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests | Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs). | From drug administration until end of trial examination, up to 13 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration (Cmax ) | Maximum measured concentration of the analyte (BI 411034) in plasma | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
| Time to Maximum Measured Concentration (Tmax) |
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Inclusion criteria:
1. Healthy male 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 |
|---|---|---|---|---|---|---|
| 1308.1.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo EM | A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM) |
| FG001 | 2mg EM | Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers |
| FG002 | 8mg EM | Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers |
| FG003 | 20mg EM | Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers |
| FG004 | 40mg EM | Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers |
| FG005 | 80mg EM | Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers |
| FG006 | 150mg EM | Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers |
| FG007 | 250mg EM | Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers |
| FG008 | Placebo PM | A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM) |
| FG009 | 20/60mg PM | Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo EM | A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM) |
| BG001 | 2mg EM | Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Maximum Measured Concentration (Cmax ) | Maximum measured concentration of the analyte (BI 411034) in plasma | PK analysis set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment and who provided at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
|
From drug administration until end of trial examination, up to 13 days
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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 EM | A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chromatopsia | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| BI 411034 high dose - group 7 | Experimental | Solution for oral administration |
|
| BI 411034 high dose - group 8 | Experimental | Solution for oral administration |
|
| Placebo | Placebo Comparator | Solution for oral administration |
|
| Placebo |
| Drug |
Solution for oral administration |
|
| BI 411034 | Drug | Medium dose solution for oral administration |
|
| BI 411034 | Drug | Low dose solution for oral administration |
|
| BI 411034 | Drug | High dose solution for oral administration |
|
| BI 411034 | Drug | High dose solution for oral administration |
|
| BI 411034 | Drug | Medium dose solution for oral administration |
|
| BI 411034 | Drug | High dose solution for oral administration |
|
| BI 411034 | Drug | Medium dose solution for oral administration |
|
Time from dosing to maximum measured concentration |
| 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
| Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity) | Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
| Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4) | Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h. | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
| BG002 | 8mg EM | Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers |
| BG003 | 20mg EM | Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers |
| BG004 | 40mg EM | Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers |
| BG005 | 80mg EM | Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers |
| BG006 | 150mg EM | Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers |
| BG007 | 250mg EM | Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers |
| BG008 | Placebo PM | A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM) |
| BG009 | 20/60mg PM | Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| 8mg EM |
Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers |
| OG002 | 20mg EM | Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers |
| OG003 | 40mg EM | Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers |
| OG004 | 80mg EM | Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers |
| OG005 | 150mg EM | Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers |
| OG006 | 250mg EM | Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers |
| OG007 | 20mg PM | Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers |
| OG008 | 60mg PM | Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers |
|
|
| Secondary | Time to Maximum Measured Concentration (Tmax) | Time from dosing to maximum measured concentration | PK analysis set | Posted | Median | Full Range | h | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
|
|
|
| Secondary | Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity) | Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
|
|
|
| Secondary | Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4) | Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h. | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol | 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration |
|
|
|
| Primary | Number of Participants With Drug Related AEs | Number of participants with drug related adverse events (AEs) | Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment | Posted | Number | participants | From drug administration until end of trial examination, up to 13 days |
|
|
|
| Primary | Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests | Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs). | Treated set | Posted | Number | participants | From drug administration until end of trial examination, up to 13 days |
|
|
|
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | 2mg EM | Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers | 0 | 6 | 0 | 6 |
| EG002 | 8mg EM | Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers | 0 | 6 | 1 | 6 |
| EG003 | 20mg EM | Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers | 0 | 6 | 1 | 6 |
| EG004 | 40mg EM | Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers | 0 | 6 | 1 | 6 |
| EG005 | 80mg EM | Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers | 0 | 6 | 2 | 6 |
| EG006 | 150mg EM | Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers | 0 | 6 | 2 | 6 |
| EG007 | 250mg EM | Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers | 0 | 6 | 3 | 6 |
| EG008 | Placebo PM | A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM) | 0 | 1 | 1 | 1 |
| EG009 | 20mg PM | Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers | 0 | 5 | 0 | 5 |
| EG010 | 60mg PM | Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers | 0 | 5 | 3 | 5 |
| Photophobia | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Feeling drunk | General disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
|
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