Trial Outcomes & Findings for A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated (NCT NCT04958252)
NCT ID: NCT04958252
Last Updated: 2026-05-22
Results Overview
Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.
Results posted on
2026-05-22
Participant Flow
This study was conducted in healthy men, and it consisted of a single-rising dose (SRD) part, a multiple dose (MD) part, and an evening pharmacokinetics (PK) part. This SRD and MD trial was designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups. The evening PK part was designed as a randomised, two-sequence, open-label, two-period, two-way crossover trial where a single dose of BI 1569912 was administered either in the morning or evening.
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.
Participant milestones
| Measure |
Single-rising Dose Part - Placebo
Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of.
Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Multiple Dose Part - Placebo
Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
|
Multiple Dose Part - 20 mg BI 1569912
Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
|
Evening Pharmacokinetics Part I - 5 mg BI 1569912 T-R
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h).
After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h.
|
Evening Pharmacokinetics Part II - 5 mg BI 1569912 R-T
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h.
|
|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
6
|
6
|
6
|
6
|
3
|
9
|
6
|
6
|
|
Period 1
Treated
|
8
|
6
|
6
|
6
|
6
|
3
|
9
|
6
|
6
|
|
Period 1
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
3
|
9
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Washout period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Washout period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Period 2
Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Period 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated
Baseline characteristics by cohort
| Measure |
Single-rising Dose Part - Placebo
n=8 Participants
Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of.
Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=6 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=6 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 10 mg
n=6 Participants
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
n=6 Participants
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Multiple Dose Part - Placebo
n=3 Participants
Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
|
Multiple Dose Part - 20 mg BI 1569912
n=9 Participants
Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
|
Evening Pharmacokinetics Part I - 5 mg BI 1569912 T-R
n=6 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h).
After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h.
|
Evening Pharmacokinetics Part II - 5 mg BI 1569912 R-T
n=6 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.6 Years
STANDARD_DEVIATION 10.9 • n=2 Participants
|
31.3 Years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
33.8 Years
STANDARD_DEVIATION 6.8 • n=6 Participants
|
30.7 Years
STANDARD_DEVIATION 6.9 • n=8 Participants
|
27.2 Years
STANDARD_DEVIATION 7.9 • n=8 Participants
|
39.0 Years
STANDARD_DEVIATION 1.7 • n=28 Participants
|
37.8 Years
STANDARD_DEVIATION 8.9
|
34.0 Years
STANDARD_DEVIATION 10.1 • n=71 Participants
|
31.0 Years
STANDARD_DEVIATION 8.4 • n=40 Participants
|
33.1 Years
STANDARD_DEVIATION 8.6 • n=120 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=28 Participants
|
9 Participants
|
6 Participants
n=71 Participants
|
6 Participants
n=40 Participants
|
56 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=28 Participants
|
9 Participants
|
6 Participants
n=71 Participants
|
6 Participants
n=40 Participants
|
56 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=2 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=28 Participants
|
9 Participants
|
6 Participants
n=71 Participants
|
6 Participants
n=40 Participants
|
56 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=28 Participants
|
0 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.Population: Treated set (TS) restricted to the SRD part included all SRD subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received.
Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
n=6 Participants
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
n=6 Participants
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=6 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=8 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
n=6 Participants
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
SRD Part - Number of Subjects With Drug-related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days.Population: Treated set restricted to the MD part included all MD subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received.
Number of subjects in the multiple dose (MD) part with drug-related adverse events is reported.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=9 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=3 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
MD Part - Number of Subjects With Drug-related Adverse Events
|
—
|
—
|
2 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.Population: Pharmacokinetic parameter evening analysis set (PKS-E) included all subjects in the TS of the evening PK part who provided at least 1 primary or secondary PK endpoint value that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK or due to PK non-evaluability. A subject was included in the PKS-E even if he contributed only 1 PK parameter value for one of the 2 periods to the statistical assessment.
Evening pharmacokinetics (PK) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Evening PK Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
—
|
—
|
817.93 hours*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.04
|
892.68 hours*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.04
|
—
|
PRIMARY outcome
Timeframe: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.Population: Pharmacokinetic parameter evening analysis set (PKS-E) included all subjects in the TS of the evening PK part who provided at least 1 primary or secondary PK endpoint value that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK or due to PK non-evaluability. A subject was included in the PKS-E even if he contributed only 1 PK parameter value for one of the 2 periods to the statistical assessment.
Evening pharmacokinetics (PK) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
|
—
|
—
|
246.01 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
372.78 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.Population: Pharmacokinetic parameter evening analysis set (PKS-E) included all subjects in the TS of the evening PK part who provided at least 1 primary or secondary PK endpoint value that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK or due to PK non-evaluability. A subject was included in the PKS-E even if he contributed only 1 PK parameter value for one of the 2 periods to the statistical assessment.
Evening pharmacokinetics (PK) part - area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Evening PK Part - Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
—
|
—
|
819.48 hours*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.04
|
894.36 hours*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.04
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.Population: PK parameter analysis set (PKS) restricted to the SRD part included all subjects in the TS of the SRD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment.
Single-rising dose (SRD) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
n=6 Participants
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
n=6 Participants
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=6 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=6 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
SRD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
1410 hours*nanomole/Liter
Geometric Coefficient of Variation 19.3
|
2790 hours*nanomole/Liter
Geometric Coefficient of Variation 15.6
|
771 hours*nanomole/Liter
Geometric Coefficient of Variation 12.9
|
360 hours*nanomole/Liter
Geometric Coefficient of Variation 12.2
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.Population: PK parameter analysis set (PKS) restricted to the SRD part included all subjects in the TS of the SRD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment.
Single-rising dose (SRD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
n=6 Participants
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
n=6 Participants
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=6 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=6 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
SRD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
|
508 nanomole/Liter
Geometric Coefficient of Variation 18.9
|
1310 nanomole/Liter
Geometric Coefficient of Variation 25.2
|
350 nanomole/Liter
Geometric Coefficient of Variation 24.0
|
124 nanomole/Liter
Geometric Coefficient of Variation 31.2
|
—
|
SECONDARY outcome
Timeframe: Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.Population: PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment.
Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma from 0 to 24 hours (h) (AUC0-24) after the first dose is reported. AUC0-24 was calculated by extrapolation
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=9 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma From 0 to 24 h (AUC0-24) After the First Dose
|
—
|
—
|
—
|
3100 hour*nanomole/Liter
Geometric Coefficient of Variation 16.6
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.Population: PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment.
Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) after the first dose is reported.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=9 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
MD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) After the First Dose
|
—
|
—
|
—
|
1280 nanomole/Liter
Geometric Coefficient of Variation 21.3
|
—
|
SECONDARY outcome
Timeframe: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.Population: PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment.
Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma over the dosing interval τ at steady state (AUCτ,ss) after the last dose is reported. The dosing interval τ is 24 hours (h).
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=9 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Dosing Interval τ at Steady State (AUCτ,ss) After the Last Dose
|
—
|
—
|
—
|
3460 hour*nanomole/Liter
Geometric Coefficient of Variation 14.0
|
—
|
SECONDARY outcome
Timeframe: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.Population: PK parameter analysis set (PKS) restricted to the MD part included all subjects in the TS of the MD part who provided at least 1 secondary PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. A subject was included in the PKS even if he contributed only 1 PK parameter value to the statistical assessment.
Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma at steady state (Cmax,ss) after the last dose is reported.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=9 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
MD Part - Maximum Measured Concentration of BI 1569912 in Plasma at Steady State (Cmax,ss) After the Last Dose
|
—
|
—
|
—
|
1300 nanomole/Liter
Geometric Coefficient of Variation 16.2
|
—
|
SECONDARY outcome
Timeframe: From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.Population: Treated set restricted to the evening PK part included all evening PK subjects who were randomised and treated with any dose of BI 1569912. The treatment assignment was determined based on the first treatment the subjects received.
Number of subjects in the evening pharmacokinetics (PK) part with drug-related adverse events is reported.
Outcome measures
| Measure |
Single-rising Dose Part - BI 1569912 10 mg
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=12 Participants
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|
|
Evening PK Part - Number of Subjects With Drug-related Adverse Events
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Single-rising Dose Part - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-rising Dose Part - BI 1569912 2.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-rising Dose Part - BI 1569912 5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-rising Dose Part - BI 1569912 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-rising Dose Part - BI 1569912 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multiple Dose Part - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Multiple Dose Part - 20 mg BI 1569912
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Evening Pharmacokinetics Part - 5 mg BI 1569912 R
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evening Pharmacokinetics Part - 5 mg BI 1569912 T
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single-rising Dose Part - Placebo
n=8 participants at risk
Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of.
Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 2.5 mg
n=6 participants at risk
Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 5 mg
n=6 participants at risk
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 10 mg
n=6 participants at risk
Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Single-rising Dose Part - BI 1569912 20 mg
n=6 participants at risk
Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
|
Multiple Dose Part - Placebo
n=3 participants at risk
Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
|
Multiple Dose Part - 20 mg BI 1569912
n=9 participants at risk
Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
|
Evening Pharmacokinetics Part - 5 mg BI 1569912 R
n=12 participants at risk
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
The administration was either preceded (part I) or followed (part II) by the administration of one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h.
Between the two treatments there was a washout period of at least 5 days.
|
Evening Pharmacokinetics Part - 5 mg BI 1569912 T
n=12 participants at risk
Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h).
The administration was either preceded (part II) or followed (part I) by the administration of one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h.
Between the two treatments there was a washout period of at least 5 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
33.3%
1/3 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/9 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/3 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
11.1%
1/9 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/3 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
22.2%
2/9 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/3 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
11.1%
1/9 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/8 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/3 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
11.1%
1/9 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.00%
0/8 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/6 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/3 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
11.1%
1/9 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
0.00%
0/12 • Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.
Treated set included all subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received. The adverse events are reported based on the time of drug administration.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER