Trial Outcomes & Findings for A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood (NCT NCT03843151)
NCT ID: NCT03843151
Last Updated: 2025-02-21
Results Overview
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Data presented come from an analysis of variance (ANOVA) model on the logarithmic scale, this model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
For each period: within 2.5 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168, 192, 216, 240, 312 and 480* hours after administration of BI 1358894. *only in the second period.
Results posted on
2025-02-21
Participant Flow
The trial was performed as an open-label, 2-treatment, 2-period, fixed sequence trial in healthy male subjects. Each subject was allocated to the same treatment sequence (Reference (R)-Test (T)).
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 |
Total of the 2-treatment, 2-period, Fixed-sequence Trial
Treatment period 1 (Reference (R)): Oral administration of single dose of 10 milligram (mg) BI 1358894 (2 tablets of 5 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1 of Treatment Period 1.
Treatment period 2 (Test (T)): Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole.
Administrations of BI 1358894 were separated by a washout interval of at least 17 days.
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|---|---|
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Overall Study
STARTED
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16
|
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Overall Study
COMPLETED
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16
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood
Baseline characteristics by cohort
| Measure |
Total of the 2-treatment, 2-period, Fixed-sequence Trial
n=16 Participants
Treatment period 1 (Reference (R)): Oral administration of single dose of 10 milligram (mg) BI 1358894 (2 tablets of 5 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1 of Treatment Period 1.
Treatment period 2 (Test (T)): Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole.
Administrations of BI 1358894 were separated by a washout interval of at least 17 days.
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|---|---|
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Age, Continuous
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35.3 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For each period: within 2.5 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168, 192, 216, 240, 312 and 480* hours after administration of BI 1358894. *only in the second period.Population: Pharmacokinetic parameter analysis set (PKS) included all subjects in the treated set 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 pharmacokinetic (PK) or due to PK non-evaluability.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Data presented come from an analysis of variance (ANOVA) model on the logarithmic scale, this model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.
Outcome measures
| Measure |
BI 1358894
n=16 Participants
Oral administration of single dose of 10 milligram (mg) BI 1358894 (2 tablets of 5 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1 of Treatment Period 1.
|
BI 1358894 + Itraconazole
n=16 Participants
Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole.
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|---|---|---|
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Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity
|
1623.89 Nanomoles*Hour per Liter
Standard Error NA
Geometric standard error = 1.07
|
3128.75 Nanomoles*Hour per Liter
Standard Error NA
Geometric standard error = 1.08
|
PRIMARY outcome
Timeframe: For each period: within 2.5 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168, 192, 216, 240, 312 and 480* hours after administration of BI 1358894. *only in the second period.Population: Pharmacokinetic parameter analysis set (PKS) included all subjects in the treated set 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 pharmacokinetic (PK) or due to PK non-evaluability.
Maximum measured concentration of BI 1358894 in plasma (Cmax). Data presented come from an analysis of variance (ANOVA) model on the logarithmic scale, this model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.
Outcome measures
| Measure |
BI 1358894
n=16 Participants
Oral administration of single dose of 10 milligram (mg) BI 1358894 (2 tablets of 5 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1 of Treatment Period 1.
|
BI 1358894 + Itraconazole
n=16 Participants
Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole.
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|---|---|---|
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Maximum Measured Concentration of BI 1358894 in Plasma
|
48.26 Nanomoles per Liter
Standard Error NA
Geometric standard error = 1.07
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58.25 Nanomoles per Liter
Standard Error NA
Geometric standard error = 1.07
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SECONDARY outcome
Timeframe: For each period: within 2.5 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 7, 8, 10, 12, 16, 24, 34, 48, 72, 96, 120, 144, 168, 192, 216, 240, 312 and 480* hours after administration of BI 1358894. *only in the second period.Population: Pharmacokinetic parameter analysis set (PKS) included all subjects in the treated set 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 pharmacokinetic (PK) or due to PK non-evaluability.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point. Data presented come from an analysis of variance (ANOVA) model on the logarithmic scale, this model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.
Outcome measures
| Measure |
BI 1358894
n=16 Participants
Oral administration of single dose of 10 milligram (mg) BI 1358894 (2 tablets of 5 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1 of Treatment Period 1.
|
BI 1358894 + Itraconazole
n=16 Participants
Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point
|
1464.49 Nanomoles*Hour per Liter
Standard Error NA
Geometric standard error = 1.07
|
2686.23 Nanomoles*Hour per Liter
Standard Error NA
Geometric standard error = 1.07
|
Adverse Events
BI 1358894
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Itraconazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BI 1358894 + Itraconazole
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
n=16 participants at risk
Oral administration of single dose of 10 milligram (mg) (2 tablets of 5 mg) BI 1358894 with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1.
|
Itraconazole
n=16 participants at risk
Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 hours once daily on Days -3 to 1 until the administration of BI 1358894.
|
BI 1358894 + Itraconazole
n=16 participants at risk
Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole.
|
|---|---|---|---|
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Ear and labyrinth disorders
Tinnitus
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
General disorders
Fatigue
|
12.5%
2/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
18.8%
3/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
General disorders
Feeling of relaxation
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
General disorders
Puncture site swelling
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Disturbance in attention
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
25.0%
4/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
0.00%
0/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 dose of trial drug.
|
6.2%
1/16 • For BI 1358894 with the beginning of first administration of BI 1358894 alone + 14 days (336 hours (h)). For itraconazole beginning with the first administration alone up to first administration of BI 1358894 administration in treatment period 2. For the combination with the beginning of administration of BI 1358894 in treatment period 2 + 6 days (144 h) after last administration of itraconazole or 14 days (336 h) after the BI 1358894 administration in treatment period 2, what occurs later.
Treated set (TS): The TS included all subjects who were treated with at least 1 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