Trial Outcomes & Findings for A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food (NCT NCT05155306)
NCT ID: NCT05155306
Last Updated: 2025-02-26
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.
Results posted on
2025-02-26
Participant Flow
This was a randomised, open-label, single-dose, four-period and four-sequence crossover trial in healthy male and female 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 |
Test Fasted - Reference Fasted - Test Fed - Reference Fed
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fasted - Reference fasted - Test fed - Reference fed, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Reference Fasted - Test Fasted - Reference Fed - Test Fed
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fasted - Test fasted - Reference fed - Test fed, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Test Fed - Reference Fed - Reference Fasted - Test Fasted
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fed - Reference fed - Reference fasted - Test fasted, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Reference Fed - Test Fed - Test Fasted - Reference Fasted
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fed - Test fed - Test fasted - Reference fasted, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out Period 1 to 2
STARTED
|
6
|
6
|
6
|
6
|
|
Wash-out Period 1 to 2
COMPLETED
|
6
|
6
|
6
|
4
|
|
Wash-out Period 1 to 2
NOT COMPLETED
|
0
|
0
|
0
|
2
|
|
Period 2
STARTED
|
6
|
6
|
6
|
4
|
|
Period 2
COMPLETED
|
6
|
6
|
6
|
4
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out Period 2 to 3
STARTED
|
6
|
6
|
6
|
4
|
|
Wash-out Period 2 to 3
COMPLETED
|
6
|
6
|
6
|
4
|
|
Wash-out Period 2 to 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
6
|
6
|
6
|
4
|
|
Period 3
COMPLETED
|
6
|
6
|
6
|
4
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out Period 3 to 4
STARTED
|
6
|
6
|
6
|
4
|
|
Wash-out Period 3 to 4
COMPLETED
|
3
|
5
|
5
|
3
|
|
Wash-out Period 3 to 4
NOT COMPLETED
|
3
|
1
|
1
|
1
|
|
Period 4
STARTED
|
3
|
5
|
5
|
3
|
|
Period 4
COMPLETED
|
3
|
5
|
5
|
3
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Fasted - Reference Fasted - Test Fed - Reference Fed
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fasted - Reference fasted - Test fed - Reference fed, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Reference Fasted - Test Fasted - Reference Fed - Test Fed
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fasted - Test fasted - Reference fed - Test fed, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Test Fed - Reference Fed - Reference Fasted - Test Fasted
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fed - Reference fed - Reference fasted - Test fasted, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Reference Fed - Test Fed - Test Fasted - Reference Fasted
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fed - Test fed - Test fasted - Reference fasted, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Wash-out Period 1 to 2
Adverse Event
|
0
|
0
|
0
|
2
|
|
Wash-out Period 3 to 4
Temporal availability
|
3
|
1
|
1
|
1
|
Baseline Characteristics
A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food
Baseline characteristics by cohort
| Measure |
Test Fasted - Reference Fasted - Test Fed - Reference Fed
n=6 Participants
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fasted - Reference fasted - Test fed - Reference fed, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Reference Fasted - Test Fasted - Reference Fed - Test Fed
n=6 Participants
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fasted - Test fasted - Reference fed - Test fed, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Test Fed - Reference Fed - Reference Fasted - Test Fasted
n=6 Participants
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Test fed - Reference fed - Reference fasted - Test fasted, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Reference Fed - Test Fed - Test Fasted - Reference Fasted
n=6 Participants
Four-period crossover with Reference and Test treatments given under either fed or faster condition in the following order: Reference fed - Test fed - Test fasted - Reference fasted, treatments were separated by a wash-out phase of at least 17 days.
Reference: a single dose of 100 mg (milligram) BI 1358894 given orally as of two 50 mg film-coated tablets in the morning.
Test: a single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.
Fed: treatment given following a high-fat, high-calorie meal.
Fasted: treatment following an overnight fast of at least 10 hours.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
44.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
39.5 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.Population: All subjects who were treated with at least one dose of the trial drug and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability were included in the pharmacokinetic analysis set (PKS). Only subjects with non-missing results were included in the analysis.
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).
Outcome measures
| Measure |
BI 1358894 - Reference - Fasted
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Test - Fasted
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Test - Fed
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal.
|
BI 1358894 - Reference - Fed
n=20 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
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)
|
8430 hours*nanomole/Liter
Geometric Coefficient of Variation 28.6
|
7360 hours*nanomole/Liter
Geometric Coefficient of Variation 38.7
|
14700 hours*nanomole/Liter
Geometric Coefficient of Variation 26.3
|
14900 hours*nanomole/Liter
Geometric Coefficient of Variation 26.6
|
PRIMARY outcome
Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.Population: All subjects who were treated with at least one dose of the trial drug and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability were included in the pharmacokinetic analysis set (PKS).
Maximum measured concentration of BI 1358894 in plasma (Cmax).
Outcome measures
| Measure |
BI 1358894 - Reference - Fasted
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Test - Fasted
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Test - Fed
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal.
|
BI 1358894 - Reference - Fed
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
|
378 nanomole/Liter
Geometric Coefficient of Variation 52.3
|
292 nanomole/Liter
Geometric Coefficient of Variation 54.9
|
445 nanomole/Liter
Geometric Coefficient of Variation 26.1
|
440 nanomole/Liter
Geometric Coefficient of Variation 23.2
|
SECONDARY outcome
Timeframe: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.Population: All subjects who were treated with at least one dose of the trial drug and who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability were included in the pharmacokinetic analysis set (PKS). Only subjects with non-missing results were included in the analysis.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
BI 1358894 - Reference - Fasted
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Test - Fasted
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Test - Fed
n=21 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal.
|
BI 1358894 - Reference - Fed
n=20 Participants
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
9120 hours*nanomole/Liter
Geometric Coefficient of Variation 28.0
|
8020 hours*nanomole/Liter
Geometric Coefficient of Variation 37.3
|
16100 hours*nanomole/Liter
Geometric Coefficient of Variation 30.3
|
15900 hours*nanomole/Liter
Geometric Coefficient of Variation 28.1
|
Adverse Events
BI 1358894 - Reference - Fasted
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
BI 1358894 - Reference - Fed
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
BI 1358894 - Test - Fasted
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
BI 1358894 - Test - Fed
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1358894 - Reference - Fasted
n=21 participants at risk
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Reference - Fed
n=21 participants at risk
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal.
|
BI 1358894 - Test - Fasted
n=21 participants at risk
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours.
|
BI 1358894 - Test - Fed
n=21 participants at risk
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
66.7%
14/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
61.9%
13/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
57.1%
12/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
47.6%
10/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
4.8%
1/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
9.5%
2/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Infections and infestations
COVID-19
|
14.3%
3/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
4.8%
1/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
4.8%
1/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
14.3%
3/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
9.5%
2/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
|
Renal and urinary disorders
Pollakiuria
|
9.5%
2/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
4.8%
1/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
4.8%
1/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/21 • All-cause Mortality: from time of administration till the end of study (EoS) examination, time of next administration or trial termination. Up to 25 days. Adverse events: from time of administration till the end of the residual effect period, time of next administration or trial termination, whichever occurs first. Up to 17 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of trial drug.
|
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
- Publication restrictions are in place