Trial Outcomes & Findings for A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood (NCT NCT04426851)
NCT ID: NCT04426851
Last Updated: 2025-03-30
Results Overview
Area under the concentration-time curve of BI 1358894 over the time interval from 0 to infinity after i.v. administration and after oral administration (AUC0-infinity) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. Standard error is actually geometric standard error. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Within 2 hours (h) before and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description.
Results posted on
2025-03-30
Participant Flow
This was a phase I trial which investigated the pharmacokinetics and absolute bioavailability of BI 1358894 administered orally as tablet co-administered with an intravenous microtracer dose of labelled \[C-14\]-BI 1358894 in healthy male volunteers via a non-randomised, open-label, fixed-sequence trial (part 1) followed by a randomised, openlabel, single-dose, two-period, two-sequence cross-over relative bioavailability trial in BI 1358894 oral suspension (part 2).
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 |
BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)
In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1).
After 15 days of washout the Part 2: Period 2 of the study started and participants received on Day 1 of Period 2 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2). After 17 days of washout Part 2: Period 3 started and participants received on Day 1 of Period 3 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2).
|
BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)
In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1).
After 15 days of washout Part 2: Period 2 started and participants received on Day 1 of Period 2 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). After 17 days of washout the Part 2: Period 3 of the study started and participants received on Day 1 of Period 3 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2).
|
|---|---|---|
|
Part 1: Period 1+Washout
STARTED
|
6
|
6
|
|
Part 1: Period 1+Washout
COMPLETED
|
6
|
6
|
|
Part 1: Period 1+Washout
NOT COMPLETED
|
0
|
0
|
|
Part 2: Period 2+Washout
STARTED
|
6
|
6
|
|
Part 2: Period 2+Washout
COMPLETED
|
5
|
5
|
|
Part 2: Period 2+Washout
NOT COMPLETED
|
1
|
1
|
|
Part 2: Period 3+Washout
STARTED
|
5
|
5
|
|
Part 2: Period 3+Washout
COMPLETED
|
5
|
5
|
|
Part 2: Period 3+Washout
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)
In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1).
After 15 days of washout the Part 2: Period 2 of the study started and participants received on Day 1 of Period 2 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2). After 17 days of washout Part 2: Period 3 started and participants received on Day 1 of Period 3 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2).
|
BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)
In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1).
After 15 days of washout Part 2: Period 2 started and participants received on Day 1 of Period 2 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). After 17 days of washout the Part 2: Period 3 of the study started and participants received on Day 1 of Period 3 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2).
|
|---|---|---|
|
Part 2: Period 2+Washout
Withdrawal by Subject
|
0
|
1
|
|
Part 2: Period 2+Washout
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood
Baseline characteristics by cohort
| Measure |
BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fasted (R2) - Fed (T2)
n=6 Participants
In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1).
After 15 days of washout the Part 2: Period 2 of the study started and participants received on Day 1 of Period 2 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2). After 17 days of washout Part 2: Period 3 started and participants received on Day 1 of Period 3 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2).
|
BI 1358894: Part 1: Tablet (T1) - (C14) i.v (R1), Part 2: Fed (T2) - Fasted (R2)
n=6 Participants
In Part 1: Period 1 of the study participants received on Day 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1). 5 hours after the oral administration (i.e. at the time of the expected tmax) participants received one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1).
After 15 days of washout Part 2: Period 2 started and participants received on Day 1 of Period 2 one single dose 100 mg BI 1358894 administered as an oral suspension with 240 mL of water following a high-fat, high-calorie breakfast when fed (Test 2-T2). After 17 days of washout the Part 2: Period 3 of the study started and participants received on Day 1 of Period 3 one single dose of 100 mg BI 1358894 administered as an oral suspension with 240 mL of water after an overnight fast of at least 10 h when fasted (Reference 2-R2).
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
37.8 Years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
38.5 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 2 hours (h) before and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 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. Thus, a subject was included in the PKS even if he contributed only 1 PK parameter value for 1 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 1358894 over the time interval from 0 to infinity after i.v. administration and after oral administration (AUC0-infinity) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. Standard error is actually geometric standard error. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1.
Outcome measures
| Measure |
BI 1358894 100 mg Tablet Fasted
n=12 Participants
On Day 1 of Part1: Period 1 participants received one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1).
|
BI 1358894 (C-14) 100 ug i.v
n=12 Participants
Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve of BI 1358894 Over the Time Interval From 0 to Infinity After i.v. Administration and After Oral Administration (AUC0-infinity)
|
96 hour*millimol/Liter/kilogram
Standard Error NA
Adjusted geometric standard error=1.093
|
209 hour*millimol/Liter/kilogram
Standard Error NA
Adjusted geometric standard error=1.093
|
PRIMARY outcome
Timeframe: Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 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. Thus, a subject was included in the PKS even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. For both arms 11 subjects were treated.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to 312 h (AUC 0-312) is reported. The values were calculated using the Analysis of variance (ANOVA) model which included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.
Outcome measures
| Measure |
BI 1358894 100 mg Tablet Fasted
n=11 Participants
On Day 1 of Part1: Period 1 participants received one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1).
|
BI 1358894 (C-14) 100 ug i.v
n=11 Participants
Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to 312 h (AUC 0-312)
|
12217 hour* nanomol/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.080
|
17271 hour* nanomol/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.080
|
SECONDARY outcome
Timeframe: Within 2 hours before and at 15 minutes (min), 30 min, 1 hour (h), 1.5, 2, 3, 4, 5, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1. Continues in description.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 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. Thus, a subject was included in the PKS even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. Descriptive and model-based analyses of PK parameters were based on the PKS.
Maximum measured concentration of BI 1358894 in plasma after i.v. administration and after oral administration(Cmax) is reported. Time Frame: For "BI 1358894 (C-14) 100 ug i.v" samples were collected at 5h, 5.083, 5.16, 5.25, 5.5, 5.75, 6, 6.5, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after oral dose of BI 1358894 on Day 1 of Period 1.
Outcome measures
| Measure |
BI 1358894 100 mg Tablet Fasted
n=12 Participants
On Day 1 of Part1: Period 1 participants received one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1).
|
BI 1358894 (C-14) 100 ug i.v
n=12 Participants
Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1.
|
|---|---|---|
|
Part 1: Maximum Measured Concentration of BI 1358894 in Plasma After i.v. Administration and After Oral Administration (Cmax)
|
408 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 34.1
|
0.847 nanomol/Liter (nmol/L)
Geometric Coefficient of Variation 28.8
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 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. Thus, a subject was included in the PKS even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. For both arms 11 subjects were treated.
Maximum measured concentration of BI 1358894 in plasma after administration of the oral suspension (Cmax) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.
Outcome measures
| Measure |
BI 1358894 100 mg Tablet Fasted
n=11 Participants
On Day 1 of Part1: Period 1 participants received one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1).
|
BI 1358894 (C-14) 100 ug i.v
n=11 Participants
Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1.
|
|---|---|---|
|
Part 2: Maximum Measured Concentration of BI 1358894 in Plasma After Administration of the Oral Suspension (Cmax)
|
810 nanomol/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.082
|
529 nanomol/Liter (nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.082
|
SECONDARY outcome
Timeframe: Within 2 hours (h) before drug administration and at 15 minutes (min), 30 min, 1 h, 1.5, 2, 3, 4, 5, 6, 7,8, 10, 12, 24, 34, 48, 72, 96, 144, 192, 240, 312 h after administration of BI 1358894.Population: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the TS who provided at least 1 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. Thus, a subject was included in the PKS even if he contributed only 1 PK parameter value for 1 period to the statistical assessment. For both arms 11 subjects were treated.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity after administration of the oral suspension (AUC0-infinity) is reported. The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Standard error is actually geometric standard error.
Outcome measures
| Measure |
BI 1358894 100 mg Tablet Fasted
n=11 Participants
On Day 1 of Part1: Period 1 participants received one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1).
|
BI 1358894 (C-14) 100 ug i.v
n=11 Participants
Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1.
|
|---|---|---|
|
Part 2: Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity After Administration of the Oral Suspension (AUC0-infinity)
|
13510 hour*nanomol/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.086
|
20052 hour*nanomol/Liter (h*nmol/L)
Standard Error NA
Adjusted geometric standard error = 1.086
|
Adverse Events
BI 1358894 100 mg Tablet Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 1358894 (C-14) 100 ug i.v
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BI 1358894 100 mg Oral Suspension Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BI 1358894 100 mg Oral Suspension Fed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1358894 100 mg Tablet Fasted
n=12 participants at risk
Participants received on Day 1 of Part 1: Period 1 one single oral dose of two 50 milligram (mg) BI 1358894 tablets (total dose=100mg) with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) (Test 1-T1).
|
BI 1358894 (C-14) 100 ug i.v
n=12 participants at risk
Participants received on Day 1 of Part 1: Period 1 one single dose of 10 mL intravenous (i.v) infusion of 100 microgram (µg) BI 1358894 using a mixture of 90 µg unlabelled and 10 µg \[C-14\] labelled BI 1358894 (Reference 1-R1). The i.v infusion started 5 hours after the administration of Test 1-T1.
|
BI 1358894 100 mg Oral Suspension Fasted
n=11 participants at risk
Participants received one single dose of 100 milligram (mg) BI 1358894 administered as an oral suspension with 240 milliliter (mL) of water after an overnight fast of at least 10 hours when fasted (Reference 2-R2).
|
BI 1358894 100 mg Oral Suspension Fed
n=11 participants at risk
Participants received one single dose of 100 milligram (mg) of BI 1358894 administered as an oral suspension with 240 milliliter (mL) of water following a high-fat, high-calorie breakfast when fed (Test 2-T2).
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
41.7%
5/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
41.7%
5/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
45.5%
5/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
63.6%
7/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
25.0%
3/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
18.2%
2/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Fatigue
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Thirst
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
16.7%
2/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Psychiatric disorders
Stress
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
8.3%
1/12 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • BI tablet = From treatment start until start of C14, up to 1 day. BI fed, BI fasted and BI C14 = day of treatment + 11 days Residual Effect Period (REP), up to 12 days.
Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.
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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