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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001717-36 | EudraCT Number |
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The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group for MRD part | Placebo Comparator | Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water. |
|
| Placebo for elderly treatment group | Placebo Comparator | Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
|
| BI 1569912 2.5 mg treatment group (MRD) | Experimental | Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
|
| BI 1569912 5 mg treatment group (MRD) | Experimental | Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1569912 | Drug | BI 1569912 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events | Number of subjects with drug-related adverse events is reported. | Up to Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24) | Area under the concentration-time curve of BI 1569912 in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) is reported. | Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration. |
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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 physical examination, vital signs (Blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
MRD- and POSO-part: Age of 18 to 45 years (inclusive); ELDERLY-part: Age of 65 to 80 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
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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 was a safety, tolerability, pharmacokinetics, and pharmacodynamics study of multiple rising oral doses of BI 1569912 (single-blind, partially randomized within dose groups, placebo-controlled, parallel group design) in healthy male subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group for MRD Part | Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water. |
| FG001 | Placebo for Elderly Treatment Group | Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
| FG002 | BI 1569912 2.5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| FG003 | BI 1569912 5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| FG004 | BI 1569912 10 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| FG005 | BI 1569912 20 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| FG006 | BI 1569912 30 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| FG007 | BI 1569912 40 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| FG008 | BI 1569912 Elderly 10/20 mg Treatment Group | Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): The treated set included all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group for MRD Part | Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water. |
| BG001 |
| 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 | Number of Subjects With Drug-related Adverse Events | Number of subjects with drug-related adverse events is reported. | Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses. | Posted | Count of Participants | Participants | Up to Day 27 |
|
For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
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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 Group for MRD Part | Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | 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 | Jan 24, 2024 | Jun 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2024 | Jun 27, 2025 | SAP_001.pdf |
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| BI 1569912 10 mg treatment group (MRD) |
| Experimental |
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
|
| BI 1569912 20 mg treatment group (MRD) | Experimental | Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
|
| BI 1569912 30 mg treatment group (MRD) | Experimental | Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
|
| BI 1569912 40 mg treatment group (MRD) | Experimental | Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
|
| BI 1569912 elderly 10/20 mg treatment group | Experimental | Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
|
| Placebo | Drug | Placebo |
|
| Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax) | Maximum measured concentration of BI 1569912 in plasma after the first dose (Cmax) is reported. | Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration. |
| Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose | Area under the concentration-time curve of BI 1569912 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the last dose is reported. | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration. |
| Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose | Maximum measured concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the last dose is reported. | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration. |
| Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose | Minimum concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after the last dose is reported. | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration. |
| Accumulation Ratio Based on Cmax,ss (RA,Cmax) After the Last Dose | Accumulation ratio based on Cmax,ss (RA,Cmax) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14. | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14. |
| Accumulation Ratio Based on AUC0-τ (RA,AUC) After the Last Dose | Accumulation ratio based on AUC0-τ 0 to tau (RA,AUC) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14. | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14. |
| Placebo for Elderly Treatment Group |
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
| BG002 | BI 1569912 2.5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| BG003 | BI 1569912 5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| BG004 | BI 1569912 10 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| BG005 | BI 1569912 20 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| BG006 | BI 1569912 30 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| BG007 | BI 1569912 40 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| BG008 | BI 1569912 Elderly 10/20 mg Treatment Group | Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
| BG009 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Placebo Elderly Treatment Group |
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
| OG002 | BI 1569912 2.5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| OG003 | BI 1569912 5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| OG004 | BI 1569912 10 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| OG005 | BI 1569912 20 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| OG006 | BI 1569912 30 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| OG007 | BI 1569912 40 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. |
| OG008 | BI 1569912 Elderly 10/20 mg Treatment Group | Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24) | Area under the concentration-time curve of BI 1569912 in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) is reported. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanomole/Liter (h*nmol/l) | Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax) | Maximum measured concentration of BI 1569912 in plasma after the first dose (Cmax) is reported. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/l) | Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose | Area under the concentration-time curve of BI 1569912 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the last dose is reported. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanomole/Liter (h*nmol/l) | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose | Maximum measured concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the last dose is reported. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/l) | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration. |
|
|
|
| Secondary | Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose | Minimum concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after the last dose is reported. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/l) | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration. |
|
|
|
| Secondary | Accumulation Ratio Based on Cmax,ss (RA,Cmax) After the Last Dose | Accumulation ratio based on Cmax,ss (RA,Cmax) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | unitless | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14. |
|
|
|
| Secondary | Accumulation Ratio Based on AUC0-τ (RA,AUC) After the Last Dose | Accumulation ratio based on AUC0-τ 0 to tau (RA,AUC) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | unitless | Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14. |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 3 |
| 17 |
| EG001 | Placebo for Elderly Treatment Group | Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG002 | BI 1569912 2.5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG003 | BI 1569912 5 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG004 | BI 1569912 10 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG005 | BI 1569912 20 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG006 | BI 1569912 30 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG007 | BI 1569912 40 mg Treatment Group (MRD) | Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. | 0 | 9 | 0 | 9 | 5 | 9 |
| EG008 | BI 1569912 Elderly 10/20 mg Treatment Group | Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. | 0 | 9 | 0 | 9 | 0 | 9 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | 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.