Trial Outcomes & Findings for A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men (NCT NCT03875001)
NCT ID: NCT03875001
Last Updated: 2025-02-26
Results Overview
Percentage of subjects with drug related adverse events (AEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Up to 14 days for 50 mg BI 1358894, 100 mg BI 1358894 and placebo. Up to 33 days for 200 mg BI 1358894.
Results posted on
2025-02-26
Participant Flow
This study tests the safety, tolerability and pharmacokinetics of single rising oral doses of BI 1358894 in healthy Japanese male subjects (double blind, randomised, placebo-controlled parallel dose group design)
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
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 1 - 50 mg BI 1358894
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 2 - 100 mg BI 1358894
1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 3 - 200 mg BI 1358894
2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 1 - 50 mg BI 1358894
n=6 Participants
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 2 - 100 mg BI 1358894
n=6 Participants
1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 3 - 200 mg BI 1358894
n=6 Participants
2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
26.3 years
STANDARD_DEVIATION 8.4 • n=107 Participants
|
32.3 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
29.8 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 7.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days for 50 mg BI 1358894, 100 mg BI 1358894 and placebo. Up to 33 days for 200 mg BI 1358894.Population: Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
Percentage of subjects with drug related adverse events (AEs).
Outcome measures
| Measure |
Placebo
n=6 Participants
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 1 - 50 mg BI 1358894
n=6 Participants
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 2 - 100 mg BI 1358894
n=6 Participants
1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 3 - 200 mg BI 1358894
n=6 Participants
2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
|---|---|---|---|---|
|
Percentage of Subjects With Drug Related Adverse Events (AEs).
|
0 Percentage
|
0 Percentage
|
16.7 Percentage
|
33.3 Percentage
|
SECONDARY outcome
Timeframe: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.Population: Pharmacokinetic Set (PKS): This set included all subjects from the treated set who provide at least one Pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK, or due to PK non-evaluability, even subjects contributing with only 1 PK parameter were included in PKS.
AUC0-tz (area under the concentration-time curve of BI 1358894 in plasma over the time interval from the time of administration to the last quantifiable data time point tz).
Outcome measures
| Measure |
Placebo
n=6 Participants
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 1 - 50 mg BI 1358894
n=6 Participants
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 2 - 100 mg BI 1358894
n=6 Participants
1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 3 - 200 mg BI 1358894
2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz).
|
6320 nanomole (nmol)* hour (h) / liter (L)
Geometric Coefficient of Variation 15.0
|
13700 nanomole (nmol)* hour (h) / liter (L)
Geometric Coefficient of Variation 23.5
|
32200 nanomole (nmol)* hour (h) / liter (L)
Geometric Coefficient of Variation 26.0
|
—
|
SECONDARY outcome
Timeframe: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.Population: Pharmacokinetic Set (PKS): This set included all subjects from the treated set who provide at least one Pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK, or due to PK non-evaluability, even subjects contributing with only 1 PK parameter were included in PKS.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity.
Outcome measures
| Measure |
Placebo
n=6 Participants
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 1 - 50 mg BI 1358894
n=6 Participants
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 2 - 100 mg BI 1358894
n=6 Participants
1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 3 - 200 mg BI 1358894
2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
6960 nanomole (nmol)* hour (h) / liter (L)
Geometric Coefficient of Variation 16.5
|
15800 nanomole (nmol)* hour (h) / liter (L)
Geometric Coefficient of Variation 20.8
|
33600 nanomole (nmol)* hour (h) / liter (L)
Geometric Coefficient of Variation 26.1
|
—
|
SECONDARY outcome
Timeframe: 2 hours before and 0.17, 0.33, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168*, 192, 240#, 336#, 504#, 672# hours following treatment. *only dose groups 1 and 2, #only dose group 3.Population: Pharmacokinetic Set (PKS): This set included all subjects from the treated set who provide at least one Pharmacokinetic (PK) endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK, or due to PK non-evaluability, even subjects contributing with only 1 PK parameter were included in PKS.
Maximum measured concentration of BI 1358894 in plasma.
Outcome measures
| Measure |
Placebo
n=6 Participants
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 1 - 50 mg BI 1358894
n=6 Participants
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 2 - 100 mg BI 1358894
n=6 Participants
1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 3 - 200 mg BI 1358894
2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
|
224 nanomole (nmol) / liter (L)
Geometric Coefficient of Variation 14.2
|
470 nanomole (nmol) / liter (L)
Geometric Coefficient of Variation 22.3
|
904 nanomole (nmol) / liter (L)
Geometric Coefficient of Variation 10.9
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Group 1 - 50 mg BI 1358894
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Group 2 - 100 mg BI 1358894
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Group 3 - 200 mg BI 1358894
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=6 participants at risk
For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 1 - 50 mg BI 1358894
n=6 participants at risk
2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 2 - 100 mg BI 1358894
n=6 participants at risk
1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
Dose Group 3 - 200 mg BI 1358894
n=6 participants at risk
2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
16.7%
1/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
16.7%
1/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
16.7%
1/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
0.00%
0/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS was used for safety analyses.
|
16.7%
1/6 • Up to 14 days for dose group 1, 2 (respectively 50 mg and 100 mg BI 1358894) and placebo and up to 33 days for dose group (200 mg BI 1358894).
Treated set: This set included data from all subjects who received at least one dose of trial drug. The TS 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