Healthy
Conditions
Brief summary
Part 1 (SRD (Single-rising dose)): The primary objective of this trial part is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single dosing. Part 2 (MRD (Multiple-rising dose)): In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple dosing.
Interventions
DRUGPlacebo Single Dose (SD)
Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours
DRUGBI 1015550 Single Dose (SD)
Subjects received single dose of BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours
DRUGPlacebo Multiple Dose (MD)
Subjects received placebo tablet matching to BI 1015550 twice daily (bid) orally with 240 milligram (mL) of water after a moderate fat meal.
DRUGBI 1015550 Multiple Dose (MD)
Subjects received BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal.
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 45 years (incl.) * 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
Exclusion criteria
* Any finding in the medical examination (including vital signs or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator * Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 55 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Any evidence of a concomitant disease judged as clinically relevant by the investigator * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy) * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders, including but not limited to mood disorders and any history of suicidality. * History of relevant orthostatic hypotension, fainting spells, or blackouts * Chronic or relevant acute infections * History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) * Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation) * Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug * Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day) * Inability to refrain from smoking on trial days * Alcohol abuse (consumption of more than 20 g per day) * Drug abuse or positive drug screening * Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial * Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial * Inability to comply with dietary regimen of trial site * A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening * A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome) * Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study * Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two months after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two months) In addition, the following trial-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events (AEs) | For SRD: From the administration of study medication until 7 days, up to day 8. For MRD: From the first administration of study medication until 7 days after the last administration of study medication, i.e. up to 21 days after first drug administration. | Number of subjects with drug-related Adverse Events (AEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 (SRD): Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration | Part 1 (SRD): Maximum measured concentration of the BI 1015550 in plasma (Cmax). |
| Part 2 (MRD) - After the First Dose : Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCτ,1) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration | Part 2 (MRD) - After the first dose : Area under the concentration-time curve of the BI 1015550 in plasma over a uniform dosing interval tau after administration of the first dose (AUCτ,1). |
| Part 2 (MRD) - After the First Dose : Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration | Part 2 (MRD) - After the first dose : Maximum measured concentration of the BI 1015550 in plasma (Cmax). |
| Part 1 (SRD): Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration | Part 1 (SRD): Area under the concentration-time curve of the BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). |
| Part 2 (MRD) - After the Last Dose: Maximum Measured Concentration of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax,ss) | Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00 | Part 2 (MRD) - After the last dose: Maximum measured concentration of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (Cmax,ss). |
| Part 2 (MRD) - Accumulation Ratio Based on Cmax,ss (RA,Cmax) | Up to 504 hours following first drug administration, Please find the time frame in description section. | Part 2 (MRD) - Accumulation ratio based on Cmax,ss (RA,Cmax). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00. |
| Part 2 (MRD) - Accumulation Ratio Based on AUC0-tau (RA,AUC) | Up to 324 hours following first drug administration, Please find the time frame in description section. | Part 2 (MRD) - Accumulation ratio based on AUC0-tau (RA,AUC). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00. |
| Part 2 (MRD) - After the Last Dose: Area Under the Concentration-time Curve of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss) | Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 311:55, 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00 | Part 2 (MRD) - After the last dose: Area under the concentration-time curve of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss). |
Countries
Germany
Participant flow
Recruitment details
Safety, tolerability, and pharmacokinetics of BI 1015550 in healthy male subjects. Single rising dose (SRD) part: Partially randomized within dose groups, placebo-controlled, single-blind, parallel-group design; Multiple rising dose (MRD) part: Partially randomized within dose groups, placebo-controlled, double-blind, parallel-group design.
Pre-assignment details
All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist site which ensured that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Single Dose (SD) Subjects received single dose of placebo tablet matching to BI 1015550 orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 | 6 |
| Placebo Multiple Dose (MD) Subjects received placebo tablet matching to BI 1015550 twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 | 8 |
| BI 1015550 36 Milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 36 mg (6 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 | 6 |
| BI 1015550 48 Milligram (mg) Single Dose (SD) Subjects received single dose of BI 1015550 48 mg (8 tablets of 6 mg) orally with 240 milligram (mL) of water after an overnight fast of at least 10 hours (h) on day 1 | 6 |
| BI 1015550 6 Milligram (mg) Twice Daily Multiple Dose (MD) Subjects received BI 1015550 6 mg (1 tablet of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 | 8 |
| BI 1015550 12 Milligram (mg) Twice Daily Multiple Dose (MD) Subjects received BI 1015550 12 mg (2 tablets of 6 mg) twice daily (bid) starting on Day 3 orally with 240 milligram (mL) of water after a moderate fat meal. Subjects were treated for 14 days and received a single morning dose on Day 1, followed by 11 day treatment and a single morning dose on Day 14 | 8 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | BI 1015550 36 Milligram (mg) Single Dose (SD) | Total | BI 1015550 12 Milligram (mg) Twice Daily Multiple Dose (MD) | BI 1015550 6 Milligram (mg) Twice Daily Multiple Dose (MD) | Placebo Multiple Dose (MD) | Placebo Single Dose (SD) | BI 1015550 48 Milligram (mg) Single Dose (SD) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.2 Years STANDARD_DEVIATION 6.6 | 34.6 Years STANDARD_DEVIATION 7 | 33.5 Years STANDARD_DEVIATION 5.3 | 35.8 Years STANDARD_DEVIATION 8.7 | 33.8 Years STANDARD_DEVIATION 6.6 | 34.3 Years STANDARD_DEVIATION 7.9 | 38.2 Years STANDARD_DEVIATION 7.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 39 Participants | 8 Participants | 8 Participants | 6 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 42 Participants | 8 Participants | 8 Participants | 8 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 6 | 3 / 8 | 4 / 6 | 4 / 6 | 2 / 8 | 5 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Number of Subjects With Drug-related Adverse Events (AEs)
Number of subjects with drug-related Adverse Events (AEs).
Time frame: For SRD: From the administration of study medication until 7 days, up to day 8. For MRD: From the first administration of study medication until 7 days after the last administration of study medication, i.e. up to 21 days after first drug administration.
Population: Treated Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Single Dose (SD) | Number of Subjects With Drug-related Adverse Events (AEs) | 1 Participants |
| Placebo Multiple Dose (MD) | Number of Subjects With Drug-related Adverse Events (AEs) | 1 Participants |
| BI 1015550 36 milligram (mg) Single Dose (SD) | Number of Subjects With Drug-related Adverse Events (AEs) | 2 Participants |
| BI 1015550 48 milligram (mg) Single Dose (SD) | Number of Subjects With Drug-related Adverse Events (AEs) | 4 Participants |
| BI 1015550 6 milligram (mg) twice daily Multiple Dose (MD) | Number of Subjects With Drug-related Adverse Events (AEs) | 2 Participants |
| BI 1015550 12 milligram (mg) twice daily Multiple Dose (MD) | Number of Subjects With Drug-related Adverse Events (AEs) | 4 Participants |
Secondary
Part 1 (SRD): Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Part 1 (SRD): Area under the concentration-time curve of the BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 1 (SRD): Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 5910 nanomole*hour/liter (nmol∙h/L) | Geometric Coefficient of Variation 21.2 |
| Placebo Multiple Dose (MD) | Part 1 (SRD): Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | 8700 nanomole*hour/liter (nmol∙h/L) | Geometric Coefficient of Variation 17.2 |
Secondary
Part 1 (SRD): Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax)
Part 1 (SRD): Maximum measured concentration of the BI 1015550 in plasma (Cmax).
Time frame: Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00 hours after drug administration
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 1 (SRD): Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | 710 nanomole/liter (nmol/L) | Geometric Coefficient of Variation 20.7 |
| Placebo Multiple Dose (MD) | Part 1 (SRD): Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | 955 nanomole/liter (nmol/L) | Geometric Coefficient of Variation 15.5 |
Secondary
Part 2 (MRD) - Accumulation Ratio Based on AUC0-tau (RA,AUC)
Part 2 (MRD) - Accumulation ratio based on AUC0-tau (RA,AUC). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00.
Time frame: Up to 324 hours following first drug administration, Please find the time frame in description section.
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 2 (MRD) - Accumulation Ratio Based on AUC0-tau (RA,AUC) | 1.85 Ratio | Geometric Coefficient of Variation 9.91 |
| Placebo Multiple Dose (MD) | Part 2 (MRD) - Accumulation Ratio Based on AUC0-tau (RA,AUC) | 1.68 Ratio | Geometric Coefficient of Variation 14.8 |
Secondary
Part 2 (MRD) - Accumulation Ratio Based on Cmax,ss (RA,Cmax)
Part 2 (MRD) - Accumulation ratio based on Cmax,ss (RA,Cmax). First Dose PK samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration. Last Dose PK samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00.
Time frame: Up to 504 hours following first drug administration, Please find the time frame in description section.
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 2 (MRD) - Accumulation Ratio Based on Cmax,ss (RA,Cmax) | 1.60 Ratio | Geometric Coefficient of Variation 35 |
| Placebo Multiple Dose (MD) | Part 2 (MRD) - Accumulation Ratio Based on Cmax,ss (RA,Cmax) | 1.52 Ratio | Geometric Coefficient of Variation 23.6 |
Secondary
Part 2 (MRD) - After the First Dose : Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCτ,1)
Part 2 (MRD) - After the first dose : Area under the concentration-time curve of the BI 1015550 in plasma over a uniform dosing interval tau after administration of the first dose (AUCτ,1).
Time frame: Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 hours after drug administration
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 2 (MRD) - After the First Dose : Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCτ,1) | 564 nanomole*hour/liter (nmol∙h/L) | Geometric Coefficient of Variation 24.8 |
| Placebo Multiple Dose (MD) | Part 2 (MRD) - After the First Dose : Area Under the Concentration-time Curve of the BI 1015550 in Plasma Over a Uniform Dosing Interval Tau After Administration of the First Dose (AUCτ,1) | 1370 nanomole*hour/liter (nmol∙h/L) | Geometric Coefficient of Variation 15.9 |
Secondary
Part 2 (MRD) - After the First Dose : Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax)
Part 2 (MRD) - After the first dose : Maximum measured concentration of the BI 1015550 in plasma (Cmax).
Time frame: Pharmacokinetic samples were taken within 2:00 hours before and 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:55 hours after drug administration
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 2 (MRD) - After the First Dose : Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | 103 nanomole/liter (nmol/L) | Geometric Coefficient of Variation 28.2 |
| Placebo Multiple Dose (MD) | Part 2 (MRD) - After the First Dose : Maximum Measured Concentration of the BI 1015550 in Plasma (Cmax) | 229 nanomole/liter (nmol/L) | Geometric Coefficient of Variation 29.9 |
Secondary
Part 2 (MRD) - After the Last Dose: Area Under the Concentration-time Curve of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss)
Part 2 (MRD) - After the last dose: Area under the concentration-time curve of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (AUCtau,ss).
Time frame: Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 311:55, 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 2 (MRD) - After the Last Dose: Area Under the Concentration-time Curve of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss) | 1050 nanomole*hour/liter (nmol∙h/L) | Geometric Coefficient of Variation 25.7 |
| Placebo Multiple Dose (MD) | Part 2 (MRD) - After the Last Dose: Area Under the Concentration-time Curve of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUCtau,ss) | 2300 nanomole*hour/liter (nmol∙h/L) | Geometric Coefficient of Variation 15.8 |
Secondary
Part 2 (MRD) - After the Last Dose: Maximum Measured Concentration of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax,ss)
Part 2 (MRD) - After the last dose: Maximum measured concentration of the BI 1015550 in plasma at steady state over a uniform dosing interval tau (Cmax,ss).
Time frame: Pharmacokinetic samples were taken within 5 minutes pre-dose and at hours 312:15, 312:30, 312:45, 313:00, 313:15, 313:30, 314:00, 315:00, 316:00, 318:00, 320:00, 324:00, 336:00, 346:00, 360:00, 384:00, 408:00, 432:00, 456:00, 480:00, 504:00
Population: Pharmacokinetic (PK) parameter set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of protocol violations relevant to the statistical evaluation of PK endpoints.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Single Dose (SD) | Part 2 (MRD) - After the Last Dose: Maximum Measured Concentration of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax,ss) | 164 nanomole/liter (nmol/L) | Geometric Coefficient of Variation 21.3 |
| Placebo Multiple Dose (MD) | Part 2 (MRD) - After the Last Dose: Maximum Measured Concentration of the BI 1015550 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax,ss) | 348 nanomole/liter (nmol/L) | Geometric Coefficient of Variation 14.1 |