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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000405-68 | EudraCT Number | EudraCT |
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In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1015550 low dose A | Experimental | Powder for oral solution |
|
| BI 1015550 low dose B | Experimental | Powder for oral solution |
|
| BI 1015550 low dose C | Experimental | Powder for oral solution |
|
| BI 1015550 low dose D | Experimental | Powder for oral solution |
|
| BI 1015550 medium dose A | Experimental | Powder for oral solution |
|
| BI 1015550 medium dose B | Experimental | Powder for oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | High dose powder for oral solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of Subjects With Drug Related Adverse Events | Percentage of subjects with drug related adverse events. | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
| Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests | Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis). | Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
| Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs | Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test). | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
| Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs | Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs. | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
| Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability | Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator. | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of BI 1015550 | Maximum measured concentration of the analyte in plasma. | -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing |
| AUC0-infinity of BI 1015550 |
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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 |
|---|---|---|---|---|---|---|
| 1305.1.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
Partially randomised, placebo-controlled within dose groups, single-blinded, single-centre study to assess the safety, tolerability and pk of single rising oral doses of BI 1015550(a powder for oral solution reconstituted with solvent tartaric acid and solvent component hydroxy-propyl-β-cyclodextrin (HPβCD)) in healthy male volunteers.
70 patients were treated and analysed.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1015550 Low Dose 0.02mg | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG001 | BI 1015550 Low Dose 0.06mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| BI 1015550 medium dose C |
| Experimental |
Powder for oral solution |
|
| BI 1015550 high dose A | Experimental | Powder for oral solution |
|
| BI 1015550 high dose B | Experimental | Powder for oral solution |
|
| Placebo | Placebo Comparator | Solution for oral administration |
|
| BI 1015550 |
| Drug |
Medium dose powder for oral solution |
|
| BI 1015550 | Drug | Low dose powder for oral solution |
|
| BI 1015550 | Drug | Low dose powder for oral solution |
|
| BI 1015550 | Drug | Low dose powder for oral solution |
|
| Placebo | Drug | Solution for oral administration |
|
| BI 101550 | Drug | High dose powder for oral solution |
|
| BI 1015550 | Drug | Low dose powder for oral solution |
|
| BI 1015550 | Drug | Medium dose powder for oral solution |
|
| BI 1015550 | Drug | Medium dose powder for oral solution |
|
| Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations |
Percentage of subjects with clinically relevant abnormalities in physical examinations. |
| From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
| -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing |
Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
| FG002 | BI 1015550 Low Dose 0.2mg | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG003 | BI 1015550 Low Dose 0.6mg | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| FG009 | Placebo | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| COMPLETED |
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| NOT COMPLETED |
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The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1015550 Low Dose 0.02mg | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG001 | BI 1015550 Low Dose 0.06mg | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG002 | BI 1015550 Low Dose 0.2mg | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG003 | BI 1015550 Low Dose 0.6mg | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| BG009 | Placebo | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| 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 | Number (%) of Subjects With Drug Related Adverse Events | Percentage of subjects with drug related adverse events. | The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. | Posted | Number | Percentage of Participants | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests | Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis). | The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. | Posted | Number | Percentage of Participants | Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs | Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test). | The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. | Posted | Number | Percentage of Participants | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs | Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs. | The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. | Posted | Number | Percentage of Participants | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability | Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator. | The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. | Posted | Number | Percentage of Participants | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations | Percentage of subjects with clinically relevant abnormalities in physical examinations. | The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. | Posted | Number | Percentage of Participants | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of BI 1015550 | Maximum measured concentration of the analyte in plasma. | The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-infinity of BI 1015550 | Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity | The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing |
|
From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 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 | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. | 0 | 16 | 5 | 16 | ||
| EG001 | BI 1015550 Low Dose 0.02mg | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 2 | 6 | ||
| EG002 | BI 1015550 Low Dose 0.06mg | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 2 | 6 | ||
| EG003 | BI 1015550 Low Dose 0.2mg | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 3 | 6 | ||
| EG004 | BI 1015550 Low Dose 0.6mg | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 3 | 6 | ||
| EG005 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 1 | 6 | ||
| EG006 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 3 | 6 | ||
| EG007 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 3 | 6 | ||
| EG008 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 2 | 6 | ||
| EG009 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | 0 | 6 | 3 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 15.1 | Systematic Assessment |
| |
| Application site irritation | General disorders | 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 15.1 | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | 15.1 | Systematic Assessment |
|
BI 1015550 high dose 24mg was originally planned as 26 mg but reduced due to PK interim analysis results of previous dose group.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
Not provided
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| Male |
|
| OG003 |
| BI 1015550 Low Dose 0.6mg |
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG009 | Placebo | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
|
|
| OG003 |
| BI 1015550 Low Dose 0.6mg |
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG009 | Placebo | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
|
|
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG009 | Placebo | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
|
|
| BI 1015550 Low Dose 0.6mg |
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG009 | Placebo | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
|
|
| BI 1015550 Low Dose 0.6mg |
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG009 | Placebo | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
|
|
| OG003 |
| BI 1015550 Low Dose 0.6mg |
Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
|
|
|
| OG003 | BI 1015550 Low Dose 0.6mg | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG004 | BI 1015550 Medium Dose 2mg | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG005 | BI 1015550 Medium Dose 4mg | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG006 | BI 1015550 Medium Dose 8mg | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG007 | BI 1015550 High Dose 16mg | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| OG008 | BI 1015550 High Dose 24mg | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
|
|
|