Trial Outcomes & Findings for A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood (NCT NCT04714073)
NCT ID: NCT04714073
Last Updated: 2025-09-12
Results Overview
Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.
Results posted on
2025-09-12
Participant Flow
Effect of itraconazole on the pharmacokinetics of a single oral dose of BI 706321 in healthy male subjects (an open-label, two-period fixed sequence design study)
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 706321 (R)/ BI 706321 + Itraconazole (T)
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2(1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
There was a washout interval of at least 14 days between the administrations of BI 706321 in the 2 trial periods.
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|---|---|
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Period 1 (+Washout Period)
STARTED
|
14
|
|
Period 1 (+Washout Period)
COMPLETED
|
14
|
|
Period 1 (+Washout Period)
NOT COMPLETED
|
0
|
|
Period 2
STARTED
|
14
|
|
Period 2
COMPLETED
|
14
|
|
Period 2
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood
Baseline characteristics by cohort
| Measure |
BI 706321 (R)/ BI 706321 + Itraconazole (T)
n=14 Participants
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2(1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
There was a washout interval of at least 14 days between the administrations of BI 706321 in the 2 trial periods.
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|---|---|
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Age, Continuous
|
32.6 Years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.Population: Pharmacokinetic parameter analysis set (PKS): All subjects in the treated set who provided at least 1 Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
BI 706321 + Itraconazole (Test Treatment(T))
n=14 Participants
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2(1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
|
BI 706321 Alone (Reference Treatment (R))
n=14 Participants
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
133.45 Hours * nanomoles / liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
60.99 Hours * nanomoles / liter
Standard Error NA
Adjusted geometric standard error = 1.10
|
PRIMARY outcome
Timeframe: Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.Population: Pharmacokinetic parameter analysis set (PKS): All subjects in the treated set who provided at least 1 Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 706321 in plasma (Cmax).
Outcome measures
| Measure |
BI 706321 + Itraconazole (Test Treatment(T))
n=14 Participants
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2(1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
|
BI 706321 Alone (Reference Treatment (R))
n=14 Participants
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
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|---|---|---|
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Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
|
3.47 nanomoles / liter
Standard Error NA
Adjusted geometric standard error = 1.14
|
2.22 nanomoles / liter
Standard Error NA
Adjusted geometric standard error = 1.14
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SECONDARY outcome
Timeframe: Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.Population: Pharmacokinetic parameter analysis set (PKS): All subjects in the treated set who provided at least 1 Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
BI 706321 + Itraconazole (Test Treatment(T))
n=14 Participants
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2(1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
|
BI 706321 Alone (Reference Treatment (R))
n=14 Participants
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
|
|---|---|---|
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Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
113.54 Hours * nanomoles / liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
50.89 Hours * nanomoles / liter
Standard Error NA
Adjusted geometric standard error = 1.12
|
Adverse Events
BI 706321 in Period 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Itraconazole Alone in Period 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 706321+Itraconazole in Period 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Total BI 706321
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 706321 in Period 1
n=14 participants at risk
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
|
Itraconazole Alone in Period 2
n=14 participants at risk
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 1 of period 2.
|
BI 706321+Itraconazole in Period 2
n=14 participants at risk
200 milligrams (mg) itraconazole were administered as oral solution formulation (concentration: 20 mL of 10 mg/milliliter (mL)) once daily with 240 mL of water after an overnight fast of at least 9 hours (h), starting from day 1 up to day 11 of period 2. On day 1 of period 2(1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h.
|
Total BI 706321
n=14 participants at risk
A total over all on treatment phase involving BI 706321.
|
Total
n=14 participants at risk
A total over all on treatment phase included in this analysis.
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|---|---|---|---|---|---|
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Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
14.3%
2/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
21.4%
3/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
21.4%
3/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
35.7%
5/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
14.3%
2/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
14.3%
2/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
14.3%
2/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
14.3%
2/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
28.6%
4/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
28.6%
4/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
0.00%
0/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study drug.
|
7.1%
1/14 • BI 706321 (BI) in period (p) 1: From BI administration in p1 until 8 days (d) thereafter, up to 8d. Itraconazole (Itra) alone in p2: From 1st Itra administration in p2 until BI administration in p2 or until last Itra administration in p2 if discontinuation prior to BI administration in p2 + 8d, up to 11d. BI+Itra in period 2: From BI administration in p2 until 8d after last study drug administration, up to 18d. Continues in description.
Continuation of time frames: Total BI: From BI administration in p1 until 8d thereafter and from BI administration in p2 until 8d after last study drug administration, up to 26d. Total: From BI administration in p1 until 8d after last study drug administration in p2, up to 29d. Safety analyses were based on the treated set (TS). The TS included all subjects who were treated with at least 1 dose of study 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 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