Trial Outcomes & Findings for A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated (NCT NCT04978506)
NCT ID: NCT04978506
Last Updated: 2026-06-26
Results Overview
Number of subjects with drug-related adverse events is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
83 participants
Primary outcome timeframe
Up to Day 27
Results posted on
2026-06-26
Participant Flow
This was a safety, tolerability, pharmacokinetics, and pharmacodynamics study of multiple rising oral doses of BI 1569912 (single-blind, partially randomized within dose groups, placebo-controlled, parallel group design) in healthy male subjects.
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 |
Placebo Group for MRD Part
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo for Elderly Treatment Group
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
3
|
9
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
16
|
3
|
8
|
8
|
9
|
9
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Group for MRD Part
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo for Elderly Treatment Group
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated
Baseline characteristics by cohort
| Measure |
Placebo Group for MRD Part
n=17 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo for Elderly Treatment Group
n=3 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
n=9 Participants
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.6 Years
STANDARD_DEVIATION 5.9 • n=20 Participants
|
67.3 Years
STANDARD_DEVIATION 0.6 • n=20 Participants
|
35.0 Years
STANDARD_DEVIATION 6.5 • n=40 Participants
|
32.9 Years
STANDARD_DEVIATION 6.4 • n=6 Participants
|
36.1 Years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
30.8 Years
STANDARD_DEVIATION 3.9 • n=13 Participants
|
32.4 Years
STANDARD_DEVIATION 5.5 • n=6 Participants
|
35.8 Years
STANDARD_DEVIATION 4.8 • n=6 Participants
|
67.6 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
39.3 Years
STANDARD_DEVIATION 12.9 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=13 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
83 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=13 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
80 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=13 Participants
|
8 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=5 Participants
|
74 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to Day 27Population: Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
Number of subjects with drug-related adverse events is reported.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=17 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=3 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
n=9 Participants
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Drug-related Adverse Events
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS.
Area under the concentration-time curve of BI 1569912 in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) is reported.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=8 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=8 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24)
|
296 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 17.5
|
618 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 19.6
|
1140 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 18.6
|
2330 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 20.3
|
3520 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 21.6
|
5280 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 23.6
|
1100 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 13.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS.
Maximum measured concentration of BI 1569912 in plasma after the first dose (Cmax) is reported.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=8 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=8 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax)
|
91.0 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 20.7
|
187 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 28.8
|
405 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 33.0
|
882 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 31.1
|
1130 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 37.6
|
1930 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 37.1
|
488 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 46.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS.
Area under the concentration-time curve of BI 1569912 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the last dose is reported.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=8 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=8 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose
|
313 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 17.7
|
709 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 17.1
|
1270 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 19.1
|
2370 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 15.7
|
3870 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 21.6
|
5610 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 21.1
|
2490 hours*nanomole/Liter (h*nmol/l)
Geometric Coefficient of Variation 8.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS.
Maximum measured concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the last dose is reported.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=8 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=8 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose
|
101 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 14.5
|
205 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 21.3
|
396 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 22.1
|
961 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 31.5
|
1300 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 31.3
|
1740 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 30.7
|
847 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 37.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS.
Minimum concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after the last dose is reported.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=8 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=8 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose
|
0.624 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 45.9
|
1.56 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 72.8
|
1.72 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 89.0
|
3.19 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 69.9
|
6.11 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 109
|
14.2 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 48.8
|
5.82 nanomole/Liter (nmol/l)
Geometric Coefficient of Variation 50.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS.
Accumulation ratio based on Cmax,ss (RA,Cmax) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=8 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=8 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio Based on Cmax,ss (RA,Cmax) After the Last Dose
|
1.11 unitless
Geometric Coefficient of Variation 28.7
|
1.09 unitless
Geometric Coefficient of Variation 26.7
|
0.978 unitless
Geometric Coefficient of Variation 24.9
|
1.08 unitless
Geometric Coefficient of Variation 52.0
|
1.15 unitless
Geometric Coefficient of Variation 51.5
|
0.899 unitless
Geometric Coefficient of Variation 25.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Descriptive and model based analyses of PK parameters were based on the PKS.
Accumulation ratio based on AUC0-τ 0 to tau (RA,AUC) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14.
Outcome measures
| Measure |
Placebo Group for MRD Part
n=8 Participants
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo Elderly Treatment Group
n=8 Participants
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 Participants
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=8 Participants
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio Based on AUC0-τ (RA,AUC) After the Last Dose
|
1.06 unitless
Geometric Coefficient of Variation 6.11
|
1.15 unitless
Geometric Coefficient of Variation 7.20
|
1.12 unitless
Geometric Coefficient of Variation 6.30
|
1.04 unitless
Geometric Coefficient of Variation 11.4
|
1.10 unitless
Geometric Coefficient of Variation 6.47
|
1.06 unitless
Geometric Coefficient of Variation 7.77
|
—
|
—
|
—
|
Adverse Events
Placebo Group for MRD Part
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo for Elderly Treatment Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 1569912 2.5 mg Treatment Group (MRD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1569912 5 mg Treatment Group (MRD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1569912 10 mg Treatment Group (MRD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 1569912 20 mg Treatment Group (MRD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1569912 30 mg Treatment Group (MRD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1569912 40 mg Treatment Group (MRD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 1569912 Elderly 10/20 mg Treatment Group
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 |
Placebo Group for MRD Part
n=17 participants at risk
Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
|
Placebo for Elderly Treatment Group
n=3 participants at risk
Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
BI 1569912 2.5 mg Treatment Group (MRD)
n=9 participants at risk
Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 5 mg Treatment Group (MRD)
n=9 participants at risk
Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 10 mg Treatment Group (MRD)
n=9 participants at risk
Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 20 mg Treatment Group (MRD)
n=9 participants at risk
Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 30 mg Treatment Group (MRD)
n=9 participants at risk
Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 40 mg Treatment Group (MRD)
n=9 participants at risk
Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
|
BI 1569912 Elderly 10/20 mg Treatment Group
n=9 participants at risk
Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
33.3%
1/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
22.2%
2/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
22.2%
2/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
22.2%
2/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.9%
1/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
11.1%
1/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/3 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
0.00%
0/9 • For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.
|
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