Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood (NCT NCT06041438)
NCT ID: NCT06041438
Last Updated: 2026-06-03
Results Overview
Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.
COMPLETED
PHASE1
14 participants
Within 3 to 4 h before and up to 3 days after BI 1584862 administration.
2026-06-03
Participant Flow
This was an open-label, two-period, two-treatment, fixed sequence design trial in healthy male subjects to investigate the effect of itraconazole on the pharmacokinetics of BI 1584862. The trial compared the test treatment (T, BI 1584862 given together with itraconazole) to the reference treatment (R, BI 1584862 given alone) using the fixed sequence R-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 |
BI 1584862 (R), Then BI 1584862 + Itraconazole (T)
Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period.
|
|---|---|
|
Reference treatment (R)
STARTED
|
14
|
|
Reference treatment (R)
Treated
|
14
|
|
Reference treatment (R)
COMPLETED
|
14
|
|
Reference treatment (R)
NOT COMPLETED
|
0
|
|
Test treatment (T)
STARTED
|
14
|
|
Test treatment (T)
Treated
|
14
|
|
Test treatment (T)
COMPLETED
|
14
|
|
Test treatment (T)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood
Baseline characteristics by cohort
| Measure |
BI 1584862 (R), Then BI 1584862 + Itraconazole (T)
n=14 Participants
Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period.
|
|---|---|
|
Age, Continuous
|
32.4 Years
STANDARD_DEVIATION 6.6 • n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Within 3 to 4 h before and up to 3 days after BI 1584862 administration.Population: Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment.
Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
BI 1584862 (R)
n=14 Participants
Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h.
|
BI 1584862 + Itraconazole (T)
n=14 Participants
Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
999.27 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.07
|
7981.53 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.07
|
PRIMARY outcome
Timeframe: Within 3 to 4 h before and up to 3 days after BI 1584862 administration.Population: PKS: this set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment.
Maximum measured concentration of BI 1584862 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
BI 1584862 (R)
n=14 Participants
Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h.
|
BI 1584862 + Itraconazole (T)
n=14 Participants
Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1584862 in Plasma (Cmax)
|
408.11 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.07
|
801.07 nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.07
|
SECONDARY outcome
Timeframe: Within 3 to 4 h before and up to 3 days after BI 1584862 administration.Population: PKS: this set included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment.
Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.
Outcome measures
| Measure |
BI 1584862 (R)
n=14 Participants
Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h.
|
BI 1584862 + Itraconazole (T)
n=14 Participants
Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
984.30 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.07
|
7825.12 hour*nanomole/Liter
Standard Error NA
Adjusted geometric standard error = 1.07
|
Adverse Events
BI 1584862 (R)
Itraconazole Before BI 1584862 (ITZ-1, T)
Itraconazole + BI 1584862 (ITZ+BI, T)
Itraconazole + BI 1584862 (ITZ-2, T)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1584862 (R)
n=14 participants at risk
Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h.
|
Itraconazole Before BI 1584862 (ITZ-1, T)
n=14 participants at risk
Healthy male subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days prior to BI 1584862 administration (test treatment, T).
|
Itraconazole + BI 1584862 (ITZ+BI, T)
n=14 participants at risk
Healthy male subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. Subjects were additionally administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h (test treatment, T).
|
Itraconazole + BI 1584862 (ITZ-2, T)
n=14 participants at risk
Healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days (test treatment, T). This arm only reports the adverse events that occurred after the end of the residual effect period of BI 1584862.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
7.1%
1/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
7.1%
1/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
7.1%
1/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
7.1%
1/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
7.1%
1/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
7.1%
1/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
0.00%
0/14 • Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place