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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003749-16 | EudraCT Number | EudraCT |
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Due to the exploratory nature of this trial, there is no primary objective in a confirmatory sense. The study aims
- to evaluate the effect of different doses of BI 409306 on biomarker and to assess the exposure of BI 409306
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 409306 25mg | Experimental |
| |
| BI 409306 50 mg | Experimental |
| |
| BI 409306 100 mg | Experimental |
| |
| BI 409306 200 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 409306 | Drug | Film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Cmax of BI 409306 in CSF Compared to Plasma | Ratio of Cmax (maximum measured concentration) of BI 409306 in Cerebrospinal fluid (CSF) compared to plasma is presented. Ratio was calculated as: Cmax of BI 409306 in CSF/ Cmax of BI 409306 in plasma. Time frame: Blood: Within 2:00 hours (h):minutes (min) before dosing and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. CSF: Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. | Pharmacokinetic samples were collected within 2 hours before and up to up to 24 hours after BI 409306 administration (please refer the description for the time frame in detail). |
| Maximum Change From Baseline of cGMP in CSF Calculated as Ratio (Emax) | The maximum change from baseline of cyclic guanosine monophosphate (cGMP) in cerebrospinal fluid (CSF) was calculated as: exp(ln(cGMPmax) - ln(cGMP0)), where cGMP0 is the baseline cGMP value per subject (mean of the two pre-dose measurements) and cGMPmax is the maximal cGMP value per subject measured after drug intake. | Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
| Maximum Relative Change From Baseline of cGMP in CSF | Maximum relative change from baseline of cyclic guanosine monophosphate (cGMP) in cerebrospinal fluid (CSF) is presented. Maximum relative change from baseline was calculated as: (cGMPmax - cGMP0)/ cGMP0, where cGMPmax is the maximum measured concentration of cGMP after dosing of BI 409306 and cGMP0 is cGMP concentration at baseline. | Within 2:00 hours (h):minutes(min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00h, 4:00, 6:00, 8:00h, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
| Maximum (Absolute) Change From Baseline of cGMP Concentration in CSF |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of BI 409306 in Plasma and CSF (Cmax) | Maximum measured concentration of BI 409306 in plasma and CSF (cerebrospinal fluid) (Cmax) is reported. Time frame: Blood: Within 2:00 hours (h): minutes (min) before dosing and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing CSF: Within 2:00 hours (h):minutes (min before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing |
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Inclusion criteria:
Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs after 10 minutes in supine position (blood pressure (BP), pulse rate (PR)), body temperature (BT)), 12-lead electrocardiogram (ECG)), clinical laboratory tests
Age =21 and Age =50 years
Body Mass Index (BMI) =18.5 and BMI =29.9 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1289.3.1 Boehringer Ingelheim Investigational Site | Antwerp | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated.
This randomised, parallel-group, double-blinded, double-dummy, single dose trial was placebo-controlled. Test product and placebo were given as a single dose to healthy male subjects in a single centre.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 409306 25mg | Subjects were orally administered single dose of BI 409306 25 milligram (mg) (5x5 mg) film-coated tablets in the morning. |
| FG001 | BI 409306 50 mg | Subjects were orally administered single dose of BI 409306 50 mg (1x50 mg) film-coated tablet in the morning. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Film-coated tablet |
|
Maximum (absolute) change from baseline of cyclic guanosine monophosphate (cGMP) concentration in cerebrospinal fluid (CSF) is presented.
The maximum (absolute) change from baseline in cGMP concentration was calculated as: maximum measured concentration of cGMP after dosing of BI 409306 (cGMPmax) - cGMP concentration at baseline (cGMP0).
| Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
| Pharmacokinetic samples were collected within 2 hours before and up to up to 24 hours after BI 409306 administration (please refer the description for the time frame in detail). |
| Time From Dosing to Maximum Measured BI 409306 Concentration in Plasma and CSF (Tmax) | Time from dosing to maximum measured BI 409306 concentration in plasma and CSF (cerebrospinal fluid) (tmax) is reported. Time frame: Blood: Within 2:00 hours (h):minutes (min) before dosing and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 h:min after dosing. CSF: Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10 , 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. | Pharmacokinetic samples were collected within 2 hours before and up to up to 24 hours after BI 409306 administration (please refer the description for the time frame in detail). |
| Maximum Measured cGMP Concentration in CSF (Cmax) | Maximum measured cyclic guanosine monophosphate (cGMP) concentration in cerebrospinal fluid (CSF) (Cmax) is reported. | Within 2:00 hours (h): minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
| Time From Dosing to Maximum Measured cGMP Concentration in CSF (Tmax) | Time from dosing to maximum measured cyclic guanosine monophosphate (cGMP) concentration in cerebrospinal fluid (CSF) (tmax) is reported. | Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
| FG002 | BI 409306 100 mg | Subjects were orally administered single dose of BI 409306 100 mg (2x50 mg) film-coated tablets in the morning. |
| FG003 | BI 409306 200 mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
| FG004 | Placebo | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning |
| COMPLETED |
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| NOT COMPLETED |
|
Treated set (TS): This analysis set included all treated subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 409306 25mg | Subjects were orally administered single dose of BI 409306 25 milligram (mg) (5x5 mg) film-coated tablets in the morning. |
| BG001 | BI 409306 50 mg | Subjects were orally administered single dose of BI 409306 50 mg (1x50 mg) film-coated tablet in the morning. |
| BG002 | BI 409306 100 mg | Subjects were orally administered single dose of BI 409306 100 mg (2x50 mg) film-coated tablets in the morning. |
| BG003 | BI 409306 200 mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
| BG004 | Placebo | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated set | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Treated Set | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Treated set | Count of Participants | Participants |
|
| 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 | Ratio of Cmax of BI 409306 in CSF Compared to Plasma | Ratio of Cmax (maximum measured concentration) of BI 409306 in Cerebrospinal fluid (CSF) compared to plasma is presented. Ratio was calculated as: Cmax of BI 409306 in CSF/ Cmax of BI 409306 in plasma. Time frame: Blood: Within 2:00 hours (h):minutes (min) before dosing and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. CSF: Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. | Pharmacokinetic Set (PKS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacokinetic endpoint and who had no important protocol violation relevant to the evaluation of pharmacokinetic parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Pharmacokinetic samples were collected within 2 hours before and up to up to 24 hours after BI 409306 administration (please refer the description for the time frame in detail). |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Change From Baseline of cGMP in CSF Calculated as Ratio (Emax) | The maximum change from baseline of cyclic guanosine monophosphate (cGMP) in cerebrospinal fluid (CSF) was calculated as: exp(ln(cGMPmax) - ln(cGMP0)), where cGMP0 is the baseline cGMP value per subject (mean of the two pre-dose measurements) and cGMPmax is the maximal cGMP value per subject measured after drug intake. | Pharmacodynamic set (PDS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacodynamic endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Relative Change From Baseline of cGMP in CSF | Maximum relative change from baseline of cyclic guanosine monophosphate (cGMP) in cerebrospinal fluid (CSF) is presented. Maximum relative change from baseline was calculated as: (cGMPmax - cGMP0)/ cGMP0, where cGMPmax is the maximum measured concentration of cGMP after dosing of BI 409306 and cGMP0 is cGMP concentration at baseline. | Pharmacodynamic set (PDS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacodynamic endpoint. | Posted | Least Squares Mean | Standard Error | Ratio | Within 2:00 hours (h):minutes(min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00h, 4:00, 6:00, 8:00h, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
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| Primary | Maximum (Absolute) Change From Baseline of cGMP Concentration in CSF | Maximum (absolute) change from baseline of cyclic guanosine monophosphate (cGMP) concentration in cerebrospinal fluid (CSF) is presented. The maximum (absolute) change from baseline in cGMP concentration was calculated as: maximum measured concentration of cGMP after dosing of BI 409306 (cGMPmax) - cGMP concentration at baseline (cGMP0). | Pharmacodynamic set (PDS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacodynamic endpoint. | Posted | Least Squares Mean | Standard Error | nanomole/Liter | Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
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| Secondary | Maximum Measured Concentration of BI 409306 in Plasma and CSF (Cmax) | Maximum measured concentration of BI 409306 in plasma and CSF (cerebrospinal fluid) (Cmax) is reported. Time frame: Blood: Within 2:00 hours (h): minutes (min) before dosing and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing CSF: Within 2:00 hours (h):minutes (min before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing | Pharmacokinetic Set (PKS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacokinetic endpoint and who had no important protocol violation relevant to the evaluation of pharmacokinetic parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/L) | Pharmacokinetic samples were collected within 2 hours before and up to up to 24 hours after BI 409306 administration (please refer the description for the time frame in detail). |
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| Secondary | Time From Dosing to Maximum Measured BI 409306 Concentration in Plasma and CSF (Tmax) | Time from dosing to maximum measured BI 409306 concentration in plasma and CSF (cerebrospinal fluid) (tmax) is reported. Time frame: Blood: Within 2:00 hours (h):minutes (min) before dosing and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, and 24:00 h:min after dosing. CSF: Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10 , 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. | Pharmacokinetic Set (PKS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacokinetic endpoint and who had no important protocol violation relevant to the evaluation of pharmacokinetic parameters. | Posted | Median | Full Range | hour | Pharmacokinetic samples were collected within 2 hours before and up to up to 24 hours after BI 409306 administration (please refer the description for the time frame in detail). |
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| Secondary | Maximum Measured cGMP Concentration in CSF (Cmax) | Maximum measured cyclic guanosine monophosphate (cGMP) concentration in cerebrospinal fluid (CSF) (Cmax) is reported. | Pharmacodynamic set (PDS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacodynamic endpoint. | Posted | Mean | Standard Deviation | nanomole/Liter (nmol/L) | Within 2:00 hours (h): minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
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| Secondary | Time From Dosing to Maximum Measured cGMP Concentration in CSF (Tmax) | Time from dosing to maximum measured cyclic guanosine monophosphate (cGMP) concentration in cerebrospinal fluid (CSF) (tmax) is reported. | Pharmacodynamic set (PDS): This analysis set included all treated subjects who provided at least 1 evaluable observation for a pharmacodynamic endpoint. | Posted | Median | Full Range | hour | Within 2:00 hours (h):minutes (min) before dosing and 0:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00 and 24:00 h:min after dosing. |
|
From first drug administration until end of the trial, ie., up to 17 days
Treated set (TS): TS included all subjects who were dispensed study medication and were 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 | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | BI 409306 25mg | Subjects were orally administered single dose of BI 409306 25 milligram (mg) (5x5 mg) film-coated tablets in the morning. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | BI 409306 50mg | Subjects were orally administered single dose of BI 409306 50 mg (1x50 mg) film-coated tablet in the morning. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | BI 409306 100mg | Subjects were orally administered single dose of BI 409306 100 mg (2x50 mg) film-coated tablets in the morning. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG004 | BI 409306 200mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. | 0 | 4 | 0 | 4 | 4 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chromatopsia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Sensation of pressure | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C000630656 | BI 409306 |
Not provided
Not provided
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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 |
|
| OG003 | BI 409306 200 mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
| OG004 | Placebo | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning |
|
|
| OG003 | BI 409306 200 mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
| OG004 | Placebo | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning |
|
|
| OG003 | BI 409306 200 mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
| OG004 | Placebo | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning |
|
|
| OG002 |
| BI 409306 100 mg |
Subjects were orally administered single dose of BI 409306 100 mg (2x50 mg) film-coated tablets in the morning. |
| OG003 | BI 409306 200 mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
|
|
| BI 409306 100 mg |
Subjects were orally administered single dose of BI 409306 100 mg (2x50 mg) film-coated tablets in the morning. |
| OG003 | BI 409306 200 mg | Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
|
|
Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
| OG004 | Placebo | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning |
|
|
Subjects were orally administered single dose of BI 409306 200 mg (1x150 mg and 1x50 mg) film-coated tablets in the morning. |
| OG004 | Placebo | Subjects were orally administered BI 409306 matching placebo film-coated tablet in the morning |
|
|