Trial Outcomes & Findings for A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood (NCT NCT05076409)
NCT ID: NCT05076409
Last Updated: 2026-05-04
Results Overview
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 215 h post administration of BI 425809 (AUC0-215) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.
Results posted on
2026-05-04
Participant Flow
Effect of fluconazole on the pharmacokinetics of a single oral dose of BI 425809 in healthy male subjects (an open-label, two-period fixed-sequence design study)
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
Participant milestones
| Measure |
BI 425809 (R)/BI 425809 + Fluconazole (T)
Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 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 16 days between the administrations of BI 425809 in the 2 trial periods.
|
|---|---|
|
BI 425809 (R) (+washout period)
STARTED
|
15
|
|
BI 425809 (R) (+washout period)
COMPLETED
|
15
|
|
BI 425809 (R) (+washout period)
NOT COMPLETED
|
0
|
|
BI 425809 + fluconazole (T)
STARTED
|
15
|
|
BI 425809 + fluconazole (T)
COMPLETED
|
15
|
|
BI 425809 + fluconazole (T)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood
Baseline characteristics by cohort
| Measure |
BI 425809 (R)/BI 425809 + Fluconazole (T)
n=15 Participants
Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 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 16 days between the administrations of BI 425809 in the 2 trial periods.
|
|---|---|
|
Age, Continuous
|
37.2 Years
STANDARD_DEVIATION 8.0 • n=54 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 215 h post administration of BI 425809 (AUC0-215) is reported.
Outcome measures
| Measure |
BI 425809 Alone (Reference Treatment (R))
n=15 Participants
Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
|
BI 425809 + Fluconazole (Test Treatment(T))
n=15 Participants
In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 215 h Post Administration of BI 425809 (AUC0-215)
|
3562.1 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.056
|
8334.6 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.056
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of BI 425809 in plasma (Cmax) is reported.
Outcome measures
| Measure |
BI 425809 Alone (Reference Treatment (R))
n=15 Participants
Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
|
BI 425809 + Fluconazole (Test Treatment(T))
n=15 Participants
In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
|
|---|---|---|
|
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
|
96.7 nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.046
|
124.1 nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.046
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.Population: Pharmacokinetic parameter analysis set (PKS): The PKS included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Outcome measures
| Measure |
BI 425809 Alone (Reference Treatment (R))
n=15 Participants
Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
|
BI 425809 + Fluconazole (Test Treatment(T))
n=15 Participants
In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
3688.4 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.073
|
10544.9 Hours * nanomoles / Liter
Standard Error NA
Adjusted geometric standard error = 1.073
|
Adverse Events
BI 425809 in Period 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fluconazole Alone in Period 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 425809+Fluconazole in Period 2
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 425809 in Period 1
n=15 participants at risk
On trial Day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
|
Fluconazole Alone in Period 2
n=15 participants at risk
In treatment period 2: 400 mg fluconazole was administered as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 1 of period 2.
|
BI 425809+Fluconazole in Period 2
n=15 participants at risk
400 mg fluconazole were administered as 2 hard capsules of 200 mg once daily (400 mg in total) orally with 240 mL of water, starting from Day 1 up to Day 9 of period 2.
On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 was administered with 240 mL of water after an overnight fast of at least 10 h.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
20.0%
3/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
20.0%
3/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
13.3%
2/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
13.3%
2/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
13.3%
2/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
0.00%
0/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one dose of study drug.
|
6.7%
1/15 • BI 425809 (BI) in period 1: From drug administration of BI in period 1 on Day 1 until 11 days (d) thereafter. Fluconazole alone in period 2: From the first Fluconazole administration in period 2 until BI administration in period 2, up to 4d. BI 425809+Fluconazole in period 2: From drug administration of BI in period 2 until 14 days (d) thereafter.
Safety analyses were based on the treated set (TS). The TS included all subjects who were entered and treated with at least one 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
- Publication restrictions are in place