Healthy
Conditions
Brief summary
To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers
Interventions
DRUGPlacebo
Placebo to BI 1015550
DRUGBI 1015550
medium dose 1 powder for oral solution
DRUGBI1015550
low dose 2 powder for oral solution
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Healthy male subjects
Exclusion criteria
1. Any relevant deviation from healthy conditions 2. Subjects unable to understand or to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Drug-related Adverse Events | From first drug administration until last drug administration, upto 18 days. | Percentage of subjects with drug related Adverse events, as assessed by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. | Maximum measured concentration of BI 1015550 in plasma. |
| AUCt,1 | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration | Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose |
| AUC0-infinity | 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. | Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity. |
| Cmax,ss | 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h. | Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t. |
| AUCt,ss | 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h. | Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t. |
Countries
Germany
Participant flow
Pre-assignment details
This study of multiple doses over 14 days was randomised, double-blind, and placebo-controlled within dose groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo to BI 1015550 Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group. | 6 |
| 1 mg BI 1015550 Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total). | 9 |
| 6 mg BI 1015550 Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total). | 9 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Other than stated above | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo to BI 1015550 | 1 mg BI 1015550 | 6 mg BI 1015550 | Total |
|---|---|---|---|---|
| Age, Continuous | 43.5 Years STANDARD_DEVIATION 9.9 | 38.7 Years STANDARD_DEVIATION 8.5 | 44.3 Years STANDARD_DEVIATION 8.3 | 42.0 Years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 6 | 4 / 9 | 1 / 9 |
| serious Total, serious adverse events | 0 / 6 | 0 / 9 | 0 / 9 |
Outcome results
Primary
Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug related Adverse events, as assessed by the investigator.
Time frame: From first drug administration until last drug administration, upto 18 days.
Population: The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo to BI 1015550 | Percentage of Subjects With Drug-related Adverse Events | 16.7 Percentage of participants |
| 1 mg BI 1015550 | Percentage of Subjects With Drug-related Adverse Events | 44.4 Percentage of participants |
| 6 mg BI 1015550 | Percentage of Subjects With Drug-related Adverse Events | 11.1 Percentage of participants |
Secondary
AUC0-infinity
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.
Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo to BI 1015550 | AUC0-infinity | 131 nmol*h/L | Geometric Coefficient of Variation 18.6 |
| 1 mg BI 1015550 | AUC0-infinity | 958 nmol*h/L | Geometric Coefficient of Variation 20.9 |
Secondary
AUCt,1
Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose
Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo to BI 1015550 | AUCt,1 | 94.9 nmol*h/L | Geometric Coefficient of Variation 10.3 |
| 1 mg BI 1015550 | AUCt,1 | 622 nmol*h/L | Geometric Coefficient of Variation 20.7 |
Secondary
AUCt,ss
Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.
Time frame: 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo to BI 1015550 | AUCt,ss | 148 nmol*h/L | Geometric Coefficient of Variation 10.7 |
| 1 mg BI 1015550 | AUCt,ss | 1090 nmol*h/L | Geometric Coefficient of Variation 19.6 |
Secondary
Cmax
Maximum measured concentration of BI 1015550 in plasma.
Time frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.
Population: The PK analysis set (PKS) included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint and who did not have a protocol violation relevant to the evaluation of PK.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo to BI 1015550 | Cmax | 24.0 nmol/L | Geometric Coefficient of Variation 25.1 |
| 1 mg BI 1015550 | Cmax | 133.0 nmol/L | Geometric Coefficient of Variation 14.9 |
Secondary
Cmax,ss
Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.
Time frame: 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo to BI 1015550 | Cmax,ss | 28.6 nmol/L | Geometric Coefficient of Variation 15.3 |
| 1 mg BI 1015550 | Cmax,ss | 199 nmol/L | Geometric Coefficient of Variation 14.5 |