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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000324-98 | EudraCT Number |
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Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
The primary objective of the single rising dose part under fasting and under fed conditions is to investigate safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of pharmacokinetics (PK) including dose proportionality, and pharmacodynamics (PD) of BI 705564 after single rising doses.
The objective of the food effect part is to explore the relative bioavailability of BI 705564 tablets under fed and fasted conditions following the oral administration of single doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo matching BI 705564 fasted (SRD part) | Experimental |
| |
| Placebo matching BI 705564 fed (SRD part) | Experimental |
| |
| 1 milligram (mg) BI 705564 fasted (SRD part) | Experimental |
| |
| 3 mg BI 705564 fasted (SRD part) | Experimental |
| |
| 10 mg BI 705564 fasted (SRD part) | Experimental |
| |
| 20 mg BI 705564 fasted (SRD part) | Experimental |
| |
| 40 mg BI 705564 fasted (SRD part) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablet and solution formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug-related Adverse Events (AEs) | Number of participants with drug-related adverse events (AEs) is presented for SRD part.Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator. | From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions). |
| Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part) | AUC0-tz, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 to the last quantifiable data point for FE part is presented. | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
| Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part) | Cmax, maximum measured concentration of BI 705564 in plasma is presented for FE part. | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (SRD Part) | Cmax, maximum measured concentration of BI 705564 in plasma is presented for SRD part. | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
-- Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR] or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant by the investigator
In addition, the following trial-specific exclusion criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomized to trial treatment if any one of the specific entry criteria were not met. For the food effect part: Single dose for each treatment (2 single doses in total) were separated by a washout period of at least 10 days
This was a study in healthy men to test how different doses of BI 705564 are taken up in the body and whether taking BI 705564 with food makes a difference. The single rising dose (SRD) parts under fasting and fed conditions were designed as partially randomised within dose groups, placebo-controlled, single-blind, parallel-group design. The food effect (FE) part was designed as open-label, randomised, single-dose, two-period, two-sequence crossover design.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching BI 705564 Fasted (SRD Part) | Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). |
| FG001 | Placebo Matching BI 705564 Fed (SRD Part) | Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| FG002 | 1 Milligram (mg) BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. |
| FG003 | 3 mg BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. |
| FG004 | 10 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG005 | 20 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG006 | 40 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG007 | 80 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| FG008 | 20 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| FG009 | 40 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| FG010 | 80 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| FG011 | 160 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| FG012 | BI 705564 10 mg Fasted/ BI 705564 10 mg Fed (FE Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after an overnight fast of at least 10 h in period 1 (fast condition), with 240 milliliters (mL) of water. Followed by single dose of 1x10 mg (10 mg) BI 705564 after a high-fat, high-calorie meal in period 2 (fed condition). Both treatments were separated by a washout period of at least 10 days. |
| FG013 | BI 705564 10 mg Fed/BI 705564 10 mg Fasted (FE Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after a high-fat, high-calorie meal in period 1 (fed condition), with 240 milliliters (mL) of water. Followed by single dose of 1x10 mg (10 mg) BI 705564 after an overnight fast of at least 10 h in period 2 (fast condition). Both treatments were separated by a washout period of at least 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): TS included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching BI 705564 Fasted (SRD Part) | Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). |
| BG001 | Placebo Matching BI 705564 Fed (SRD Part) |
| Units | Counts |
|---|---|
| Participants |
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| 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 Participants With Drug-related Adverse Events (AEs) | Number of participants with drug-related adverse events (AEs) is presented for SRD part.Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator. | Treated set (TS): TS included all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of the investigational treatment. | Posted | Count of Participants | Participants | From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions). |
|
From drug administration until end of the treatment, up to 15 days (for SRD part fasting and fed condition and FE part).
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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 Matching BI 705564 Fasted (SRD Part) | Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 20.1 | 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 11, 2017 | Mar 15, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2018 | Mar 15, 2022 | SAP_001.pdf |
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| 80 mg BI 705564 fasted (SRD part) | Experimental |
|
| 20 mg BI 705564 fed (SRD part) | Experimental |
|
| 40 mg BI 705564 fed (SRD part) | Experimental |
|
| 80 mg BI 705564 fed (SRD part) | Experimental |
|
| 160 mg BI 705564 fed (SRD part) | Experimental |
|
| BI 705564 10 mg fasted/ BI 705564 10 mg fed (FE Part) | Experimental |
|
| BI 705564 10 mg fed/ BI 705564 10 mg fasted (FE Part) | Experimental |
|
| BI 705564 (Test) | Drug | Fed state |
|
| BI 705564 (Reference) | Drug | Fasting state |
|
| Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (SRD Part) | AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity is presented for SRD part. | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
| Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (FE Part) | AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity. | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| BG002 | 1 Milligram (mg) BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. |
| BG003 | 3 mg BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. |
| BG004 | 10 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG005 | 20 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG006 | 40 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG007 | 80 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| BG008 | 20 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| BG009 | 40 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| BG010 | 80 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| BG011 | 160 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| BG012 | BI 705564 10 mg Fasted/ BI 705564 10 mg Fed (FE Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after an overnight fast of at least 10 h in period 1 (fast condition), with 240 milliliters (mL) of water. Followed by single dose of 1x10 mg (10 mg) BI 705564 after a high-fat, high-calorie meal in period 2 (fed condition). Both treatments were separated by a washout period of at least 10 days. |
| BG013 | BI 705564 10 mg Fed/BI 705564 10 mg Fasted (FE Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet after a high-fat, high-calorie meal in period 1 (fed condition), with 240 milliliters (mL) of water. Followed by single dose of 1x10 mg (10 mg) BI 705564 after an overnight fast of at least 10 h in period 2 (fast condition). Both treatments were separated by a washout period of at least 10 days. |
| BG014 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo Matching BI 705564 Fed (SRD Part) | Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| OG002 | Placebo Matching BI 705564 Total | Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition. |
| OG003 | 1 Milligram (mg) BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. |
| OG004 | 3 mg BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. |
| OG005 | 10 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG006 | 20 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG007 | 40 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG008 | 80 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG009 | Total BI 705564 Fast (SRD Part) | Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. |
| OG010 | 20 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| OG011 | 40 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| OG012 | 80 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| OG013 | 160 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. |
| OG014 | Total BI 705564 Fed (SRD Part) | Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal |
| OG015 | Total BI 705564 (SRD Part) | Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition. |
|
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| Primary | Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part) | AUC0-tz, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 to the last quantifiable data point for FE part is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability. | Posted | Least Squares Mean | Standard Error | nanomole*hour/litre [nmol*h/L] | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
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| Primary | Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part) | Cmax, maximum measured concentration of BI 705564 in plasma is presented for FE part. | Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability. | Posted | Least Squares Mean | Standard Error | Nanomole/litre [nmol/L] | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
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| Secondary | Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (SRD Part) | Cmax, maximum measured concentration of BI 705564 in plasma is presented for SRD part. | Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole/litre [nmol/L] | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
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| Secondary | Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (SRD Part) | AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity is presented for SRD part. | Pharmacokinetic (PK) parameter analysis set (PKS): PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter (AUC0-∞ or Cmax) that was not excluded due to a protocol violation relevant to the evaluation of PK or due to non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole*hour/litre [nmol*h/L] | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
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| Secondary | Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (FE Part) | AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity. | PKS: Only participants with evaluable results for this PK parameter are reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole*hour/litre [nmol*h/L] | Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration. |
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|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 6 |
| 12 |
| EG001 | Placebo Matching BI 705564 Fed (SRD Part) | Participants were administered single dose of placebo matching BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | Placebo Matching BI 705564 Total | Participants were administered single dose of placebo matching BI 705564 orally as powder for oral solution or film-coated tablet with 240 milliliters (mL) of water after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition. | 0 | 20 | 0 | 20 | 9 | 20 |
| EG003 | 1 Milligram (mg) BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 1 mg BI 705564 (4 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | 3 mg BI 705564 Fasted (SRD Part) | Participants were administered a single dose of 3 mg BI 705564 (12 milliliter x 0.25 milligram/milliliter (mg/mL)) orally from a reconstitution of powder for oral solution 20 mg with Solvent for Oral Solution 80 mL (HP-ß-Cyclodextrin 100 mg/mL) after an overnight fast of at least 10 h. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG005 | 10 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | 20 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | 40 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG008 | 80 mg BI 705564 Fasted (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG009 | Total BI 705564 Fast (SRD Part) | Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 35 | 0 | 35 | 12 | 35 |
| EG010 | 20 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 2x10 mg (20 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG011 | 40 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 4x10 mg (40 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG012 | 80 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 8x10 mg (80 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG013 | 160 mg BI 705564 Fed (SRD Part) | Participants were administered single dose of 1x100 mg and 6x10 mg (160 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG014 | Total BI 705564 Fed (SRD Part) | Participants were administered single dose of BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal | 0 | 24 | 0 | 24 | 10 | 24 |
| EG015 | Total BI 705564 (SRD Part) | Participants were administered single dose of BI 705564 orally as powder for oral solution or film-coated tablet with 240 mL of water as after an overnight fast of at least 10 h in fast condition or after a high-fat, high-calorie meal in fed condition. | 0 | 59 | 0 | 59 | 22 | 59 |
| EG016 | 10 mg BI 705564 Fast (FE Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after an overnight fast of at least 10 h. | 0 | 12 | 0 | 12 | 2 | 12 |
| EG017 | 10 mg BI 705564 Fed (FE Part) | Participants were administered single dose of 1x10 mg (10 mg) BI 705564 orally as film-coated tablet with 240 mL of water after a high-fat, high-calorie meal. | 0 | 11 | 0 | 11 | 2 | 11 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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Not provided
Not provided
No hypothesis was tested and no acceptance range was specified.
No hypothesis was tested and no acceptance range was specified.
| The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints. | Slope | 0.7553 | Standard Error of the Mean | 0.0876 | 2-Sided | 95 | 0.5736 | 0.9370 | Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1. | Other |
| The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints. | Power model | Slope | 0.6651 | Standard Error of the Mean | 0.1385 | 2-Sided | 95 | 0.3679 | 0.9622 | Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1. | Other |