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The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-rising dose part - BI 1569912 2.5 mg | Experimental | Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
|
| Single-rising dose part - BI 1569912 5 mg | Experimental | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
|
| Single-rising dose part - BI 1569912 10 mg | Experimental | Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
|
| Single-rising dose part - BI 1569912 20 mg | Experimental | Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
|
| Multiple dose part - 20 mg BI 1569912 | Experimental | Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1569912 | Drug | BI 1569912 |
|
| Measure | Description | Time Frame |
|---|---|---|
| SRD Part - Number of Subjects With Drug-related Adverse Events | Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported. | From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours. |
| MD Part - Number of Subjects With Drug-related Adverse Events | Number of subjects in the multiple dose (MD) part with drug-related adverse events is reported. | From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. |
| Evening PK Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Evening pharmacokinetics (PK) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration. |
| Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) | Evening pharmacokinetics (PK) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Evening PK Part - Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Evening pharmacokinetics (PK) part - area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. |
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Inclusion Criteria:
Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
Age of 18 to 45 years (inclusive)
Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Sumida Hospital | Tokyo, Sumida-ku | 130-0004 | Japan |
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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, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This study was conducted in healthy men, and it consisted of a single-rising dose (SRD) part, a multiple dose (MD) part, and an evening pharmacokinetics (PK) part.
This SRD and MD trial was designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups.
The evening PK part was designed as a randomised, two-sequence, open-label, two-period, two-way crossover trial where a single dose of BI 1569912 was administered either in the morning or evening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-rising Dose Part - Placebo | Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of. Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours. |
| FG001 | Single-rising Dose Part - BI 1569912 2.5 mg | Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| FG002 | Single-rising Dose Part - BI 1569912 5 mg | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| FG003 | Single-rising Dose Part - BI 1569912 10 mg | Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| FG004 | Single-rising Dose Part - BI 1569912 20 mg | Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| FG005 | Multiple Dose Part - Placebo | Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. |
| FG006 | Multiple Dose Part - 20 mg BI 1569912 | Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. |
| FG007 | Evening Pharmacokinetics Part I - 5 mg BI 1569912 T-R | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h. |
| FG008 | Evening Pharmacokinetics Part II - 5 mg BI 1569912 R-T | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout period |
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| Period 2 |
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Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-rising Dose Part - Placebo | Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of. Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours. |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SRD Part - Number of Subjects With Drug-related Adverse Events | Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported. | Treated set (TS) restricted to the SRD part included all SRD subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. | Posted | Count of Participants | Participants | From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours. |
|
Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received.
The adverse events are reported based on the time of drug administration.
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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 | Single-rising Dose Part - Placebo | Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of. Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2023 | Apr 28, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2023 | Apr 28, 2026 | SAP_001.pdf |
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The single-rising dose part and multiple dose part of the trial is designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups.
The evening pharmacokinetics part is designed as a randomised, two-sequence, open-label, two period, two-way cross over trial.
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The single-rising dose part and multiple dose part of the trial are designed single-blind (to participants).
The evening pharmacokinetics part is designed as open-label trial.
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|
| Multiple dose part - Placebo | Placebo Comparator | Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. |
|
| Evening pharmacokinetics part I - 5 mg BI 1569912 T-R | Experimental | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h. |
|
| Evening pharmacokinetics part II - 5 mg BI 1569912 R-T | Experimental | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h. |
|
| Single-rising dose part - Placebo | Placebo Comparator | Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of. Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours. |
|
| Placebo | Drug | Placebo |
|
| Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration. |
| Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration. |
| SRD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Single-rising dose (SRD) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration. |
| SRD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) | Single-rising dose (SRD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported. | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration. |
| MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma From 0 to 24 h (AUC0-24) After the First Dose | Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma from 0 to 24 hours (h) (AUC0-24) after the first dose is reported. AUC0-24 was calculated by extrapolation | Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration. |
| MD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) After the First Dose | Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) after the first dose is reported. | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration. |
| MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Dosing Interval τ at Steady State (AUCτ,ss) After the Last Dose | Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma over the dosing interval τ at steady state (AUCτ,ss) after the last dose is reported. The dosing interval τ is 24 hours (h). | One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration. |
| MD Part - Maximum Measured Concentration of BI 1569912 in Plasma at Steady State (Cmax,ss) After the Last Dose | Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma at steady state (Cmax,ss) after the last dose is reported. | One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration. |
| Evening PK Part - Number of Subjects With Drug-related Adverse Events | Number of subjects in the evening pharmacokinetics (PK) part with drug-related adverse events is reported. | From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours. |
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| NOT COMPLETED |
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| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Single-rising Dose Part - BI 1569912 2.5 mg | Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| BG002 | Single-rising Dose Part - BI 1569912 5 mg | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| BG003 | Single-rising Dose Part - BI 1569912 10 mg | Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| BG004 | Single-rising Dose Part - BI 1569912 20 mg | Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| BG005 | Multiple Dose Part - Placebo | Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. |
| BG006 | Multiple Dose Part - 20 mg BI 1569912 | Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. |
| BG007 | Evening Pharmacokinetics Part I - 5 mg BI 1569912 T-R | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h. |
| BG008 | Evening Pharmacokinetics Part II - 5 mg BI 1569912 R-T | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h. |
| BG009 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Single-rising Dose Part - BI 1569912 2.5 mg | Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| OG002 | Single-rising Dose Part - BI 1569912 5 mg | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| OG003 | Single-rising Dose Part - BI 1569912 10 mg | Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
| OG004 | Single-rising Dose Part - BI 1569912 20 mg | Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. |
|
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| Primary | MD Part - Number of Subjects With Drug-related Adverse Events | Number of subjects in the multiple dose (MD) part with drug-related adverse events is reported. | Treated set restricted to the MD part included all MD subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. | Posted | Count of Participants | Participants | From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. |
|
|
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| Primary | Evening PK Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Evening pharmacokinetics (PK) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. | Pharmacokinetic parameter evening analysis set (PKS-E) included all subjects in the TS of the evening PK part who provided at least 1 primary or secondary PK endpoint value that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK or due to PK non-evaluability. A subject was included in the PKS-E even if he contributed only 1 PK parameter value for one of the 2 periods to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomole/Liter | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration. |
|
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| Primary | Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) | Evening pharmacokinetics (PK) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. | Pharmacokinetic parameter evening analysis set (PKS-E) included all subjects in the TS of the evening PK part who provided at least 1 primary or secondary PK endpoint value that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK or due to PK non-evaluability. A subject was included in the PKS-E even if he contributed only 1 PK parameter value for one of the 2 periods to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration. |
|
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| Secondary | Evening PK Part - Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Evening pharmacokinetics (PK) part - area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale. | Pharmacokinetic parameter evening analysis set (PKS-E) included all subjects in the TS of the evening PK part who provided at least 1 primary or secondary PK endpoint value that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK or due to PK non-evaluability. A subject was included in the PKS-E even if he contributed only 1 PK parameter value for one of the 2 periods to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hours*nanomole/Liter | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration. |
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| Secondary | SRD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Single-rising dose (SRD) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | PK parameter analysis set (PKS) restricted to the SRD part included all subjects in the TS of the SRD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanomole/Liter | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration. |
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| Secondary | SRD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) | Single-rising dose (SRD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported. | PK parameter analysis set (PKS) restricted to the SRD part included all subjects in the TS of the SRD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration. |
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| Secondary | MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma From 0 to 24 h (AUC0-24) After the First Dose | Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma from 0 to 24 hours (h) (AUC0-24) after the first dose is reported. AUC0-24 was calculated by extrapolation | PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanomole/Liter | Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration. |
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| Secondary | MD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) After the First Dose | Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) after the first dose is reported. | PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter | Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration. |
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| Secondary | MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Dosing Interval τ at Steady State (AUCτ,ss) After the Last Dose | Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma over the dosing interval τ at steady state (AUCτ,ss) after the last dose is reported. The dosing interval τ is 24 hours (h). | PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanomole/Liter | One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration. |
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| Secondary | MD Part - Maximum Measured Concentration of BI 1569912 in Plasma at Steady State (Cmax,ss) After the Last Dose | Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma at steady state (Cmax,ss) after the last dose is reported. | PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter | One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration. |
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| Secondary | Evening PK Part - Number of Subjects With Drug-related Adverse Events | Number of subjects in the evening pharmacokinetics (PK) part with drug-related adverse events is reported. | Treated set restricted to the evening PK part included all evening PK subjects who were randomised and treated with any dose of BI 1569912. The treatment assignment was determined based on the first treatment the subjects received. | Posted | Count of Participants | Participants | From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours. |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Single-rising Dose Part - BI 1569912 2.5 mg | Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Single-rising Dose Part - BI 1569912 5 mg | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Single-rising Dose Part - BI 1569912 10 mg | Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Single-rising Dose Part - BI 1569912 20 mg | Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | Multiple Dose Part - Placebo | Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG006 | Multiple Dose Part - 20 mg BI 1569912 | Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG007 | Evening Pharmacokinetics Part - 5 mg BI 1569912 R | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). The administration was either preceded (part I) or followed (part II) by the administration of one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h. Between the two treatments there was a washout period of at least 5 days. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG008 | Evening Pharmacokinetics Part - 5 mg BI 1569912 T | Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h). The administration was either preceded (part II) or followed (part I) by the administration of one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h. Between the two treatments there was a washout period of at least 5 days. | 0 | 12 | 0 | 12 | 0 | 12 |
| Somnolence | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Peripheral nerve injury | Injury, poisoning and procedural complications | MedDRA 26.1 | 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.
| Other |
| Other |
| Other |