Trial Outcomes & Findings for Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects (NCT NCT02383888)
NCT ID: NCT02383888
Last Updated: 2026-03-30
Results Overview
This outcome measure presents the number of subjects with drug-related adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
Up to 11 days after drug administration.
Results posted on
2026-03-30
Participant Flow
This was a randomised, double-blind, placebo-controlled trial to investigate safety, tolerability and pharmacokinetics (PK) following single rising doses of BI 425809 in healthy Japanese and Chinese men, and to explore dose proportionality of BI 425809.
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
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=13 Participants
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Age, Continuous
|
27.7 Years
STANDARD_DEVIATION 6.90 • n=4 Participants
|
28.2 Years
STANDARD_DEVIATION 3.81 • n=28 Participants
|
27.3 Years
STANDARD_DEVIATION 4.75 • n=10 Participants
|
30.5 Years
STANDARD_DEVIATION 8.04 • n=38 Participants
|
28.4 Years
STANDARD_DEVIATION 6.06 • n=33 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=4 Participants
|
12 Participants
n=28 Participants
|
12 Participants
n=10 Participants
|
12 Participants
n=38 Participants
|
49 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=4 Participants
|
12 Participants
n=28 Participants
|
12 Participants
n=10 Participants
|
12 Participants
n=38 Participants
|
49 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Up to 11 days after drug administration.Population: Treated Set (TS): This analysis set included all subjects who received the study drug.
This outcome measure presents the number of subjects with drug-related adverse events.
Outcome measures
| Measure |
Placebo
n=13 Participants
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Number of Subjects With Drug-Related Adverse Events (AEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.Population: Pharmacokinetic Set (PKS): This set included all evaluable subjects of the treated set who were treated with BI 425809, and provided at least one observation for at least one PK secondary endpoint, and had no important Protocol Violations (PVs) relevant for the statistical evaluation of dose proportionality.
This outcome measure presents maximum measured concentration of BI 425809 in plasma (Cmax).
Outcome measures
| Measure |
Placebo
n=12 Participants
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
|
124 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 23.0
|
235 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 20.9
|
417 nanomole/Liter (nmol/L)
Geometric Coefficient of Variation 18.5
|
—
|
SECONDARY outcome
Timeframe: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.Population: Pharmacokinetic Set (PKS): This set included all evaluable subjects of the treated set who were treated with BI 425809, and provided at least one observation for at least one PK secondary endpoint, and had no important Protocol Violations (PVs) relevant for the statistical evaluation of dose proportionality.
This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
Placebo
n=12 Participants
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Area Under the Concentration (AUC0-∞) Time Curve of BI 425809
|
4370 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 28.0
|
8940 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 34.9
|
14800 nanomole*hour/Liter (nmol*h/L)
Geometric Coefficient of Variation 17.6
|
—
|
SECONDARY outcome
Timeframe: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.Population: Pharmacokinetic Set (PKS): This set included all evaluable subjects of the treated set who were treated with BI 425809, and provided at least one observation for at least one PK secondary endpoint, and had no important Protocol Violations (PVs) relevant for the statistical evaluation of dose proportionality.
This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz).
Outcome measures
| Measure |
Placebo
n=12 Participants
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Area Under the Concentration (AUC0-tz) Time Curve of BI 425809
|
4190 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 23.6
|
8540 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 30.1
|
14600 nanomole*hour/liter (nmol*h/L)
Geometric Coefficient of Variation 17.7
|
—
|
SECONDARY outcome
Timeframe: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.Population: Pharmacokinetic Set (PKS): This set included all evaluable subjects of the treated set who were treated with BI 425809, and provided at least one observation for at least one PK secondary endpoint, and had no important Protocol Violations (PVs) relevant for the statistical evaluation of dose proportionality.
This outcome measure presents time from dosing to the maximum concentration of BI 425809 in plasma (tmax).
Outcome measures
| Measure |
Placebo
n=12 Participants
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Tmax of BI 425809
|
4.00 hour (h)
Interval 2.0 to 5.0
|
4.00 hour (h)
Interval 2.0 to 6.0
|
4.00 hour (h)
Interval 2.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.Population: Pharmacokinetic Set (PKS): This set included all evaluable subjects of the treated set who were treated with BI 425809, and provided at least one observation for at least one PK secondary endpoint, and had no important Protocol Violations (PVs) relevant for the statistical evaluation of dose proportionality.
This outcome measure presents terminal half-life of BI 425809 in plasma (t1/2).
Outcome measures
| Measure |
Placebo
n=12 Participants
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 Participants
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
t1/2 of BI 425809
|
35.2 hour (h)
Geometric Coefficient of Variation 42.7
|
34.6 hour (h)
Geometric Coefficient of Variation 48.4
|
29.1 hour (h)
Geometric Coefficient of Variation 20.9
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 425809 10 mg Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BI 425809 25 mg Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BI 425809 50 mg Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=13 participants at risk
The subjects were administered a single dose of placebo tablet matching BI 425809 orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours with the same posology of the respective active treatment.
|
BI 425809 10 mg Tablet
n=12 participants at risk
The subjects were administered a single dose of BI 425809 10 milligram (mg) (5 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 25 mg Tablet
n=12 participants at risk
The subjects were administered a single dose of BI 425809 25 mg tablet orally with 240 mL water after an overnight fast of at least 10 hours.
|
BI 425809 50 mg Tablet
n=12 participants at risk
The subjects were administered a single dose of BI 425809 50 mg (25 mg tablet\*2) orally with 240 mL water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/13 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
8.3%
1/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/13 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
8.3%
1/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/13 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
8.3%
1/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
0.00%
0/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
8.3%
1/12 • Adverse events: up to 11 days after drug administration.
Treated Set (TS): This analysis set included all subjects who received the study drug.
|
Additional Information
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