Trial Outcomes & Findings for This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood (NCT NCT03403439)
NCT ID: NCT03403439
Last Updated: 2025-11-28
Results Overview
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to 119 hours (h) (AUC0-119). Standard error is actually geometric standard error. Geometric mean (gMean) is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 hours:minutes (h:m) prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
COMPLETED
PHASE1
16 participants
Up to 215 hours (Please check measure description for detailed timeframe)
2025-11-28
Participant Flow
This was as an open-label, fixed-sequence trial with 2 treatments, administered to healthy male participants to compare itraconazole + BI 1015550 (T) with BI 1015550 alone (R). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 days.
All participants were screened for eligibility to participate in the trial. Participants attended specialist site which would then ensure that they (all participants) met all inclusion/exclusion criteria. Participants were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
BI 1015550 alone (R) / itraconazole + BI 1015550 (T)
Participants were administered single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours on Day 1 of Visit 2. Again participants were administered itraconazole plus BI 1015550; participants received 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 days.
|
|---|---|
|
Treatment Period 1 + Washout (7 days)
STARTED
|
16
|
|
Treatment Period 1 + Washout (7 days)
COMPLETED
|
16
|
|
Treatment Period 1 + Washout (7 days)
NOT COMPLETED
|
0
|
|
Treatment Period 2 (21 days)
STARTED
|
16
|
|
Treatment Period 2 (21 days)
COMPLETED
|
16
|
|
Treatment Period 2 (21 days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood
Baseline characteristics by cohort
| Measure |
BI 1015550 Alone (R) / Itraconazole + BI 1015550 (T)
n=16 Participants
Participants were administered single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours on Day 1 of Visit 2. Again participants were administered itraconazole plus BI 1015550; participants received 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 days.
|
|---|---|
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Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 10.2 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 215 hours (Please check measure description for detailed timeframe)Population: Pharmacokinetic (PK) set (PKS): The PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was not excluded. 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 1015550 in plasma over the time interval from 0 to 119 hours (h) (AUC0-119). Standard error is actually geometric standard error. Geometric mean (gMean) is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 hours:minutes (h:m) prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Outcome measures
| Measure |
itraconazole + BI 1015550 (T)
n=16 Participants
Participants were administered itraconazole plus BI 1015550; 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single oral dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration).
|
BI 1015550 alone (R)
n=16 Participants
Participants were administered alone with single dose of BI 1015550 6 mg tablet orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of Visit 2.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to 119 Hours
|
2073.40 nanomole (nmol)*h/Litre (L)
Standard Error NA
Geometric standard error = 1.07
|
933.44 nanomole (nmol)*h/Litre (L)
Standard Error NA
Geometric standard error = 1.07
|
PRIMARY outcome
Timeframe: Up to 215 hours (Please check measure description for detailed timeframe)Population: PKS
Maximum measured concentration of the BI 1015550 in plasma (Cmax). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Outcome measures
| Measure |
itraconazole + BI 1015550 (T)
n=16 Participants
Participants were administered itraconazole plus BI 1015550; 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single oral dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration).
|
BI 1015550 alone (R)
n=16 Participants
Participants were administered alone with single dose of BI 1015550 6 mg tablet orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of Visit 2.
|
|---|---|---|
|
Maximum Measured Concentration of the BI 1015550 in Plasma
|
162.39 nmol/L
Standard Error NA
Geometric standard error = 1.06
|
126.91 nmol/L
Standard Error NA
Geometric standard error = 1.06
|
SECONDARY outcome
Timeframe: Up to 215 hours (Please check measure description for detailed timeframe)Population: PKS
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.
Outcome measures
| Measure |
itraconazole + BI 1015550 (T)
n=16 Participants
Participants were administered itraconazole plus BI 1015550; 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single oral dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration).
|
BI 1015550 alone (R)
n=16 Participants
Participants were administered alone with single dose of BI 1015550 6 mg tablet orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of Visit 2.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
|
2183.22 nmol*h/L
Standard Error NA
Geometric standard error = 1.08
|
952.27 nmol*h/L
Standard Error NA
Geometric standard error = 1.08
|
Adverse Events
BI 1015550
itraconazole
itraconazole + BI 1015550
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1015550
n=16 participants at risk
Participants were administered single dose of BI 1015550 6 mg tablet orally with 240 mL of water, in treatment R.
|
itraconazole
n=16 participants at risk
Participants were administered itraconazole 200 mg solution orally once daily with 240 mL of water after an overnight fast of at least 9 h, in treatment T only for 3 days from Day -3 to Day -1 of Visit 3.
|
itraconazole + BI 1015550
n=16 participants at risk
Participants were administered itraconazole plus BI 1015550; participants received 9 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day 1 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on Day 1 (1 hour after the itraconazole administration).
|
|---|---|---|---|
|
Infections and infestations
Conjunctivitis
|
6.2%
1/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
6.2%
1/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
31.2%
5/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
12.5%
2/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
12.5%
2/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
6.2%
1/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
6.2%
1/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
12.5%
2/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
General disorders
Thirst
|
6.2%
1/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
|
Psychiatric disorders
Sleep disorder
|
6.2%
1/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
0.00%
0/16 • From the first BI 1015550 administration until end of trial, up to 28 days (i.e. 7 days for BI 1015550, 3 days for itraconazole and up to 18 days for itraconazole + BI 1015550).
TS
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place