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BI 691751 is currently being developed to inhibit growth and prevent rupture of atherosclerotic plaques and to consequently reduce the risk of major cardiovascular events in patients with established atherosclerotic disease. 1334.5 is a Pan Asian Phase 1 study to investigate safety, tolerability and pharmacokinetics of BI 691751 in healthy Chinese and Japanese male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 691751 low dose 1 | Experimental | BI 691751 low dose 1 |
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| BI 691751 low dose 2 | Experimental | BI 691751 low dose 2 |
|
| BI 691751 middle dose | Experimental | BI 691751 middle dose |
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| BI 691751 high dose | Experimental | BI 691751 high dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 691751 | Drug | Placebo to BI 691751 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug Related Adverse Events | Percentage of participants with drug related adverse events (AEs) | From drug administration until 31 days after drug administration, 31 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of the Analyte (Cmax) | Maximum measured concentration of the analyte in plasma/whole blood | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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Inclusion criteria:
Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
Chinese ethnicity, Japanese ethnicity according to the following criteria:
Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China Japanese; born in Japan and holding Japanese passport, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan
Age within the range of 20 to 45 years
Body mass index within the range of 18.5 and 25 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1334.5.82001 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chinese: Placebo | Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG001 | Chinese: BI 691751 5mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BI 691751 high dose |
| Drug |
BI 691751 high dose |
|
| BI 691751 middle dose | Drug | BI 691751 middle dose |
|
| Placebo to BI 691751 | Drug | Placebo to BI 691751 |
|
| BI 691751 low dose 1 | Drug | BI 691751 low dose 1 |
|
| Placebo to BI 691751 | Drug | Placebo to BI 691751 |
|
| Placebo to BI 691751 | Drug | Placebo to BI 691751 |
|
| BI 691751 low dose 2 | Drug | BI 691751 low dose 2 |
|
| Maximum Measured Concentration of the Analyte (Cmax) - Overall |
Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese) |
| 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) | Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall | Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese) | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity) | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese) | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese) | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Terminal Half-life of the Analyte (T1/2) | Terminal half-life (T1/2) of the analyte in plasma/whole blood | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| Terminal Half-life of the Analyte (T1/2) - Overall | Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese) | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
| FG002 | Chinese: BI 691751 10mg | Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG003 | Chinese: BI 691751 30mg | Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG004 | Chinese: BI 691751 60mg | Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG005 | Japanese: Placebo | Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG006 | Japanese: BI 691751 5mg | Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG007 | Japanese: BI 691751 10mg | Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG008 | Japanese: BI 691751 30mg | Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| FG009 | Japanese: BI 691751 60mg | Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Treated set which included all subjects who were documented to have taken study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chinese: Placebo | Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG001 | Chinese: BI 691751 5mg | Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG002 | Chinese: BI 691751 10mg | Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG003 | Chinese: BI 691751 30mg | Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG004 | Chinese: BI 691751 60mg | Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG005 | Japanese: Placebo | Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG006 | Japanese: BI 691751 5mg | Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG007 | Japanese: BI 691751 10mg | Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG008 | Japanese: BI 691751 30mg | Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG009 | Japanese: BI 691751 60mg | Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| BG010 | 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | 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 | Percentage of Participants With Drug Related Adverse Events | Percentage of participants with drug related adverse events (AEs) | Treated set | Posted | Number | Percentage of participants | From drug administration until 31 days after drug administration, 31 days |
|
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| Secondary | Maximum Measured Concentration of the Analyte (Cmax) | Maximum measured concentration of the analyte in plasma/whole blood | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Measured Concentration of the Analyte (Cmax) - Overall | Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese) | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) | Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Median | Full Range | hours | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall | Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese) | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Median | Full Range | hours | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity) | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese) | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall | Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese) | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Terminal Half-life of the Analyte (T1/2) | Terminal half-life (T1/2) of the analyte in plasma/whole blood | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
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| Secondary | Terminal Half-life of the Analyte (T1/2) - Overall | Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese) | All subjects of the treated set with the pharmacokinetic (PK) parameter calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration |
|
From drug administration until 31 days after drug administration, 31 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 | Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours. | 0 | 16 | 6 | 16 | ||
| EG001 | BI 691751 5mg | Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. | 0 | 12 | 6 | 12 | ||
| EG002 | BI 691751 10mg | Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. | 0 | 12 | 4 | 12 | ||
| EG003 | BI 691751 30mg | Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. | 0 | 12 | 3 | 12 | ||
| EG004 | BI 691751 60mg | Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. | 0 | 12 | 7 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | 17.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | 17.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 17.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 17.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | 17.0 | 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 |
| Male |
|
Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG004 | Japanese: BI 691751 5mg | Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG005 | Japanese: BI 691751 10mg | Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG006 | Japanese: BI 691751 30mg | Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG007 | Japanese: BI 691751 60mg | Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG004 | Japanese: BI 691751 5mg | Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG005 | Japanese: BI 691751 10mg | Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG006 | Japanese: BI 691751 30mg | Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG007 | Japanese: BI 691751 60mg | Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
| OG003 | Chinese: BI 691751 60mg | Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG004 | Japanese: BI 691751 5mg | Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG005 | Japanese: BI 691751 10mg | Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG006 | Japanese: BI 691751 30mg | Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG007 | Japanese: BI 691751 60mg | Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
| OG003 | BI 691751 60mg | Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
| OG003 | Chinese: BI 691751 60mg | Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG004 | Japanese: BI 691751 5mg | Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG005 | Japanese: BI 691751 10mg | Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG006 | Japanese: BI 691751 30mg | Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG007 | Japanese: BI 691751 60mg | Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
| OG003 | BI 691751 60mg | Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
|
|
Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG004 | Japanese: BI 691751 5mg | Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG005 | Japanese: BI 691751 10mg | Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG006 | Japanese: BI 691751 30mg | Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours. |
| OG007 | Japanese: BI 691751 60mg | Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
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Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours. |
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