Trial Outcomes & Findings for A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood (NCT NCT06861829)
NCT ID: NCT06861829
Last Updated: 2026-08-11
Results Overview
Area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
COMPLETED
PHASE1
12 participants
Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration
2026-08-11
Participant Flow
This was an open-label, two-period, two-sequence, crossover clinical trial in healthy male subjects conducted to evaluate the study treatment under food-effect.
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 3731579 Fasted - Fed (R-T)
Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.
|
BI 3731579 Fed - Fasted (T-R)
Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.
|
|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
6
|
6
|
|
Washout
COMPLETED
|
6
|
6
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood
Baseline characteristics by cohort
| Measure |
BI 3731579 Fasted - Fed (R-T)
n=6 Participants
Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.
|
BI 3731579 Fed - Fasted (T-R)
n=6 Participants
Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.0 Years
STANDARD_DEVIATION 8.9 • n=54 Participants
|
32.8 Years
STANDARD_DEVIATION 10.9 • n=54 Participants
|
31.9 Years
STANDARD_DEVIATION 9.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administrationPopulation: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was defined as primary 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/she contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Outcome measures
| Measure |
BI 3731579 Fed (T)
n=12 Participants
Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast.
|
BI 3731579 Fasted (R)
n=12 Participants
Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
15045.02 hours*nanomoles/Liters (h*nmol/L)
Standard Error NA
adjusted geometric standard error = 1.08
|
16708.83 hours*nanomoles/Liters (h*nmol/L)
Standard Error NA
adjusted geometric standard error = 1.08
|
PRIMARY outcome
Timeframe: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administrationPopulation: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was defined as primary 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/she contributed only one PK parameter value for one period to the statistical assessment.
Maximum measured concentration of BI 3731579 in plasma (Cmax) is presented.
Outcome measures
| Measure |
BI 3731579 Fed (T)
n=12 Participants
Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast.
|
BI 3731579 Fasted (R)
n=12 Participants
Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h.
|
|---|---|---|
|
Maximum Measured Concentration of BI 3731579 in Plasma (Cmax)
|
2115.09 nanomoles/Liters (nmol/L)
Standard Error NA
adjusted geometric standard error = 1.09
|
2784.23 nanomoles/Liters (nmol/L)
Standard Error NA
adjusted geometric standard error = 1.09
|
SECONDARY outcome
Timeframe: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administrationPopulation: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was defined as primary 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/she contributed only one PK parameter value for one period to the statistical assessment.
Area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.
Outcome measures
| Measure |
BI 3731579 Fed (T)
n=12 Participants
Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast.
|
BI 3731579 Fasted (R)
n=12 Participants
Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
15491.36 hours*nanomoles/Liters (h*nmol/L)
Standard Error NA
adjusted geometric standard error = 1.08
|
17038.10 hours*nanomoles/Liters (h*nmol/L)
Standard Error NA
adjusted geometric standard error = 1.08
|
Adverse Events
BI 3731579 Fasted (R)
BI 3731579 Fed (T)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 3731579 Fasted (R)
n=12 participants at risk
Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h.
|
BI 3731579 Fed (T)
n=12 participants at risk
Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Renal and urinary disorders
Urine odour abnormal
|
8.3%
1/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
8.3%
1/12 • For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place