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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004390-16 | EudraCT Number |
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The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 425809 very low dose - part I | Experimental | Part I only - very low dose tablet, oral administration with 240 ml water, over 14 days |
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| Placebo - part I | Placebo Comparator | Part I only - placebo tablet, oral administration with 240ml water, over 14 days |
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| BI 425809 low dose - part I | Experimental | Part I - low dose tablet, oral administration with 240 ml water, over 14 days |
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| BI 425809 medium dose - part I | Experimental | Part I only - medium dose tablet, oral administration with 240 ml water, over 14 days |
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| BI 425809 high dose -part I | Experimental | Part I only - high dose tablet, oral administration with 240 ml water, over 14 days |
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| BI 425809 low dose - part II | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 425809 | Drug | Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I | Percentage of subjects with drug related adverse events (AEs) in part I is reported | From first dose of study medication until 11 days after the last dose of study medication, up to 25 days |
| Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Part II | Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) part II is reported. | PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration |
| Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part II | Maximum measured concentration of the BI 425809 in plasma (Cmax) part II. | PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Drug Related Adverse Events (AEs) in Part II | Percentage of subjects with drug related adverse events (AEs) in part II is reported. | From first dose of study medication until 11 days after the last dose of study medication, up to 12 days |
| Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Part II |
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Inclusion criteria:
Healthy male or female subjects according to the investigator´s assessment, 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
age of 18 to 50 years (incl.) for young healthy volunteers or age of 65 to 80 years (incl.) for elderly healthy volunteers
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
Female subjects who meet any of the following criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29846887 | Derived | Moschetti V, Schlecker C, Wind S, Goetz S, Schmitt H, Schultz A, Liesenfeld KH, Wunderlich G, Desch M. Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics. Clin Drug Investig. 2018 Aug;38(8):737-750. doi: 10.1007/s40261-018-0660-2. |
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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 Phase I trial evaluated safety, tolerability, and pharmacokinetics of BI 425809 in healthy volunteers: Part 1 tested multiple rising doses (randomized, double-blind, placebo-controlled); Part 2 compared single-dose morning vs evening (randomized, crossover).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - BI 425809- Young Healthy Subjects (YH) | Young Healthy subjects received matching placebo to BI 425809 orally with approximately 240 milliliter (mL) of water. |
| FG001 | Placebo - BI 425809- Elderly Healthy Subjects (EH) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Part II - one low dose tablet on day 1 of visit 2 and 2a |
| BI 425809 very high dose -part I | Experimental | Part I only - very high dose tablet, oral administration with 240 ml water, over 14 days |
|
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| Placebo | Drug | Tablets |
|
Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) part II. After single dosing in the morning as well as in the evening. |
| PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration |
| Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) Part I | Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to 24 hours (AUC0-24) part I. After the first dose. | PK plasma samples were taken at: 2 hours before drug administration and 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24 hours after the drug administration in YH and EH population |
| Area Under the Concentration-time Curve of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUCÏ„,ss) Part I | The AUC of BI 425809 in plasma at steady state over a dosing interval (AUCÏ„,ss) in Part I was evaluated for all arms achieving steady state. For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to nonlinear pharmacokinetics; therefore, AUCÏ„,ss was not determined. Instead, AUCÏ„ after the final dose (AUCÏ„,22) was calculated, representing AUC over one dosing interval (Ï„; dosing interval) after the last dose on Day 14 (22nd dose), not at steady state. PK sampling: 75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-minute time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose. Other arms: 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-minute time points), 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose. Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH. | Up to 528 hours. The details are described in description. |
| Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part I | Maximum measured concentration of the BI 425809 in plasma (Cmax) part I. After the first dose. | PK plasma samples were taken at: 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48 and 58 hours after drug administration. |
| Maximum Measured Concentration of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) Part I | Maximum measured plasma concentration of BI 425809 at steady state over a dosing interval (Cmax,ss) in Part I was evaluated for all treatment arms achieving steady state For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to non-linear pharmacokinetics; therefore, Cmax,ss was not determined. Instead, Cmax after the final dose (Cmax,22) was calculated, representing the maximum observed concentration following the last dose on Day 14 (22nd dose), not at steady-state PK sampling: 75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-min time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose Other arms: 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-min time points); 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH | Up to 528 hours. The details are described in description. |
Elderly Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water.
| FG002 | BI 425809 - 10 Milligram (mg) Multiple Dose in YH | Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| FG003 | BI 425809 - 25 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| FG004 | BI 425809 - 25 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| FG005 | BI 425809 - 50 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| FG006 | BI 425809 - 50 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| FG007 | BI 425809 - 75 mg Once Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| FG008 | BI 425809 - 75 mg Twice Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14 |
| FG009 | BI 425809 - 25 mg Single Dose Morning (R) / Evening (T) in YH | Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the morning (Reference (R)) and then single dose of 25 mg of BI 425809 orally in the evening (Test (T)) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days. |
| FG010 | BI 425809 - 25 mg Single Dose Evening (T) / Morning (R) in YH | Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the evening (T) and then single dose of 25 mg of BI 425809 orally in the morning (R) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days. |
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| NOT COMPLETED |
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The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - BI 425809- Young Healthy Subjects (YH) | Young Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water. |
| BG001 | Placebo - BI 425809- Elderly Healthy Subjects (EH) | Elderly Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water. |
| BG002 | BI 425809 - 10 Milligram (mg) Multiple Dose in YH | Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| BG003 | BI 425809 - 25 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| BG004 | BI 425809 - 25 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| BG005 | BI 425809 - 50 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| BG006 | BI 425809 - 50 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| BG007 | BI 425809 - 75 mg Once Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| BG008 | BI 425809 - 75 mg Twice Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14 |
| BG009 | BI 425809 - 25 mg Single Dose Morning (R) / Evening (T) in YH | Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the morning (Reference (R)) and then single dose of 25 mg of BI 425809 orally in the evening (Test (T)) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days. |
| BG010 | BI 425809 - 25 mg Single Dose Evening (T) / Morning (R) in YH | Young Healthy subjects first received single dose of 25 mg of BI 425809 orally in the evening (T) and then single dose of 25 mg of BI 425809 orally in the morning (R) with approximately 240 mL of water. Trial drug administration is separated by a wash-out period of at least 11 days. |
| BG011 | Total | Total of all reporting groups |
| 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 | The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug. | Count of Participants | Participants |
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| Race (NIH/OMB) | The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug. | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Subjects With Drug Related Adverse Events (AEs) in Part I | Percentage of subjects with drug related adverse events (AEs) in part I is reported | The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug. | Posted | Number | Percentage of participants | From first dose of study medication until 11 days after the last dose of study medication, up to 25 days |
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| Primary | Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) Part II | Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) part II is reported. | Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomol (nmol)* hours (h) / Litre (L) | PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration |
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| Primary | Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part II | Maximum measured concentration of the BI 425809 in plasma (Cmax) part II. | Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration |
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| Secondary | Percentage of Subjects With Drug Related Adverse Events (AEs) in Part II | Percentage of subjects with drug related adverse events (AEs) in part II is reported. | The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug. | Posted | Number | Percentage of participants | From first dose of study medication until 11 days after the last dose of study medication, up to 12 days |
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| Secondary | Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) Part II | Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity) part II. After single dosing in the morning as well as in the evening. | Pharmacokinetic evening set (PKS-E): set included all subjects from the TS who participated in part 2 of the trial and provided at least 1 primary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the bioavailability evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | PK samples were taken at: 0, 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 hours after drug administration |
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| Secondary | Area Under the Concentration-time Curve of the BI 425809 in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) Part I | Area under the concentration-time curve of the BI 425809 in plasma over the time interval from 0 to 24 hours (AUC0-24) part I. After the first dose. | Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | PK plasma samples were taken at: 2 hours before drug administration and 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24 hours after the drug administration in YH and EH population |
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| Secondary | Area Under the Concentration-time Curve of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUCÏ„,ss) Part I | The AUC of BI 425809 in plasma at steady state over a dosing interval (AUCÏ„,ss) in Part I was evaluated for all arms achieving steady state. For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to nonlinear pharmacokinetics; therefore, AUCÏ„,ss was not determined. Instead, AUCÏ„ after the final dose (AUCÏ„,22) was calculated, representing AUC over one dosing interval (Ï„; dosing interval) after the last dose on Day 14 (22nd dose), not at steady state. PK sampling: 75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-minute time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose. Other arms: 0:30, 1-6 h (including 30-minute time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-minute time points), 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose. Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH. | Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | Up to 528 hours. The details are described in description. |
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| Secondary | Maximum Measured Concentration of the BI 425809 in Plasma (Cmax) Part I | Maximum measured concentration of the BI 425809 in plasma (Cmax) part I. After the first dose. | Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | PK plasma samples were taken at: 0:30, 1, 2, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 24, 34, 48 and 58 hours after drug administration. |
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| Secondary | Maximum Measured Concentration of the BI 425809 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) Part I | Maximum measured plasma concentration of BI 425809 at steady state over a dosing interval (Cmax,ss) in Part I was evaluated for all treatment arms achieving steady state For the 75 mg twice-daily multiple-dose arm in young healthy subjects (YH), steady state was not achieved due to non-linear pharmacokinetics; therefore, Cmax,ss was not determined. Instead, Cmax after the final dose (Cmax,22) was calculated, representing the maximum observed concentration following the last dose on Day 14 (22nd dose), not at steady-state PK sampling: 75 mg BID YH: 2 h pre-dose and 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264, 288, 312-324 h (including 30-min time points), 336, 360, 384, 408, 432, 456, 480, 504, 528 h post-dose Other arms: 0:30, 1-6 h (including 30-min time points), 8, 10, 12, 24-240 h, 264-272 h (including 30-min time points); 288, 360, 384, 408, 432, 456, 480, 504, and 528 h post-dose Time points 264-272 h apply only to 25 mg multiple-dose arms in YH and EH | Pharmacokinetic set (PKS): This subject set included all subjects from the TS who received BI 425809, participated in part 1 of the trial, and provided at least 1 secondary PK endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the dose proportionality evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Up to 528 hours. The details are described in description. |
|
Adverse events (AEs), serious adverse events (SAEs), and all-cause mortality were collected from first dose until 11 days after the last dose of study medication in both Part I and Part II, including the washout period in Part II. This corresponded to a maximum duration of approximately 25 days in Part I and 23 days in Part II.
The treated set (TS) included all subjects from the randomised set (RS) who were documented to have received at least 1 dose of trial drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - BI 425809- Young Healthy Subjects (YH) | Young Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water. | 0 | 15 | 0 | 15 | 8 | 15 |
| EG001 | Placebo - BI 425809- Elderly Healthy Subjects (EH) | Elderly Healthy subjects received matching placebo to BI 425809 orally with approximately 240 mL of water. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | BI 425809 - 10 Milligram (mg) Multiple Dose in YH | Young Healthy subjects received multiple doses of 10 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 | 0 | 9 | 0 | 9 | 5 | 9 |
| EG003 | BI 425809 - 25 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 | 0 | 9 | 0 | 9 | 7 | 9 |
| EG004 | BI 425809 - 25 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 | 0 | 9 | 0 | 9 | 8 | 9 |
| EG005 | BI 425809 - 50 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 | 0 | 9 | 0 | 9 | 6 | 9 |
| EG006 | BI 425809 - 50 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 | 0 | 9 | 0 | 9 | 8 | 9 |
| EG007 | BI 425809 - 75 mg Once Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 | 0 | 9 | 0 | 9 | 6 | 9 |
| EG008 | BI 425809 - 75 mg Twice Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14 | 0 | 9 | 0 | 9 | 6 | 9 |
| EG009 | BI 425809 - 25 mg Single Dose Morning (R) in YH | Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the morning with approximately 240 mL of water. | 0 | 12 | 0 | 12 | 2 | 12 |
| EG010 | BI 425809 - 25 mg Single Dose Evening (T) in YH | Young Healthy subjects received single dose of 25 mg of BI 425809 orally in the evening with approximately 240 mL of water. | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | 18.1 | Systematic Assessment |
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| Blepharospasm | Eye disorders | 18.1 | Systematic Assessment |
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| Eye pain | Eye disorders | 18.1 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | 18.1 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | 18.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | 18.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | 18.1 | Systematic Assessment |
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| Visual acuity reduced transiently | Eye disorders | 18.1 | Systematic Assessment |
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| Visual impairment | Eye disorders | 18.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Faeces hard | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 18.1 | Systematic Assessment |
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| Fatigue | General disorders | 18.1 | Systematic Assessment |
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| Feeling cold | General disorders | 18.1 | Systematic Assessment |
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| Feeling drunk | General disorders | 18.1 | Systematic Assessment |
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| Gait disturbance | General disorders | 18.1 | Systematic Assessment |
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| Puncture site swelling | General disorders | 18.1 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | 18.1 | Systematic Assessment |
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| Vessel puncture site swelling | General disorders | 18.1 | Systematic Assessment |
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| Bacteriuria | Infections and infestations | 18.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | 18.1 | Systematic Assessment |
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| Mastitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | 18.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | 18.1 | Systematic Assessment |
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| Breath sounds abnormal | Investigations | 18.1 | Systematic Assessment |
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| Intraocular pressure test | Investigations | 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 18.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 18.1 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 18.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | 18.1 | Systematic Assessment |
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| Hyposmia | Nervous system disorders | 18.1 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | 18.1 | Systematic Assessment |
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| Mood altered | Psychiatric disorders | 18.1 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | 18.1 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | 18.1 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | 18.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | 18.1 | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | 18.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| C000634404 | BI 425809 |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Participants |
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| OG002 |
| BI 425809 - 25 mg Multiple Dose in EH |
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG003 | BI 425809 - 50 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG004 | BI 425809 - 50 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG005 | BI 425809 - 75 mg Once Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG006 | BI 425809 - 75 mg Twice Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14 |
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|
|
| OG001 | BI 425809 - 25 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG002 | BI 425809 - 25 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG003 | BI 425809 - 50 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG004 | BI 425809 - 50 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG005 | BI 425809 - 75 mg Once Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG006 | BI 425809 - 75 mg Twice Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14 |
|
|
|
Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG003 | BI 425809 - 50 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG004 | BI 425809 - 50 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG005 | BI 425809 - 75 mg Once Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG006 | BI 425809 - 75 mg Twice Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14 |
|
|
|
| OG001 | BI 425809 - 25 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG002 | BI 425809 - 25 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 25 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG003 | BI 425809 - 50 mg Multiple Dose in YH | Young Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG004 | BI 425809 - 50 mg Multiple Dose in EH | Elderly Healthy subjects received multiple doses of 50 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG005 | BI 425809 - 75 mg Once Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally once daily with approximately 240 mL of water. One single dose on Day 1 followed by once daily dosing on Days 4 to 14 |
| OG006 | BI 425809 - 75 mg Twice Daily Multiple Dose in YH | Young Healthy subjects received multiple doses of 75 mg of BI 425809 orally twice daily with approximately 240 mL of water. One single dose on Day 1 followed by twice daily dosing on Days 4 to 13 and a single morning dose on Day 14 |
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