Trial Outcomes & Findings for A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food (NCT NCT05347004)
NCT ID: NCT05347004
Last Updated: 2026-04-20
Results Overview
This outcome measured the area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) following its administration in fed and fasted state. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
COMPLETED
PHASE1
16 participants
From within 2 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 47, 71, 119, 167 and 215 hours after BI 425809 administration.
2026-04-20
Participant Flow
This was a randomised, open-label, two-period, two-sequence crossover trial, in which a total of 16 healthy male and female subjects were randomly allocated to the 2 treatment sequences (BI 425809 without food (R), then BI 425809 with food (T) or BI 425809 with food (T), then BI 425809 without food (R)) in a 1:1 ratio. A washout period of at least 14 days occurred between treatments.
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 425809 Without Food (R), Then BI 425809 With Food (T)
Two period crossover, with participants receiving the treatments in the following order:
BI 425809 without food (R) - Period 1: single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, after an overnight fast of, at least, 10 hours.
BI 425809 with food (T) - Period 2: single dose of one 10 mg film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 mL of water, 30 minutes after a high-fat, high-calorie meal.
Between each treatment at least a 14 day washout period occurred.
|
BI 425809 With Food (T), Then BI 425809 Without Food (R)
Two period crossover, with participants receiving the treatments in the following order:
BI 425809 with food (T) - Period 1: single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, 30 minutes after a high-fat, high-calorie meal.
BI 425809 without food (R) - Period 2: single dose of one 10 mg film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 mL of water, after an overnight fast of, at least, 10 hours.
Between each treatment at least a 14 day washout period occurred.
|
|---|---|---|
|
Treatment period 1
STARTED
|
8
|
8
|
|
Treatment period 1
COMPLETED
|
8
|
8
|
|
Treatment period 1
NOT COMPLETED
|
0
|
0
|
|
Washout period
STARTED
|
8
|
8
|
|
Washout period
COMPLETED
|
7
|
8
|
|
Washout period
NOT COMPLETED
|
1
|
0
|
|
Treatment period 2
STARTED
|
7
|
8
|
|
Treatment period 2
COMPLETED
|
7
|
8
|
|
Treatment period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
BI 425809 Without Food (R), Then BI 425809 With Food (T)
Two period crossover, with participants receiving the treatments in the following order:
BI 425809 without food (R) - Period 1: single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, after an overnight fast of, at least, 10 hours.
BI 425809 with food (T) - Period 2: single dose of one 10 mg film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 mL of water, 30 minutes after a high-fat, high-calorie meal.
Between each treatment at least a 14 day washout period occurred.
|
BI 425809 With Food (T), Then BI 425809 Without Food (R)
Two period crossover, with participants receiving the treatments in the following order:
BI 425809 with food (T) - Period 1: single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, 30 minutes after a high-fat, high-calorie meal.
BI 425809 without food (R) - Period 2: single dose of one 10 mg film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 mL of water, after an overnight fast of, at least, 10 hours.
Between each treatment at least a 14 day washout period occurred.
|
|---|---|---|
|
Washout period
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food
Baseline characteristics by cohort
| Measure |
BI 425809 With Food (T), Then BI 425809 Without Food (R)
n=8 Participants
Two period crossover, with participants receiving the treatments in the following order:
BI 425809 with food (T) - Period 1: single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, 30 minutes after a high-fat, high-calorie meal.
BI 425809 without food (R) - Period 2: single dose of one 10 mg film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 mL of water, after an overnight fast of, at least, 10 hours.
Between each treatment at least a 14 day washout period occurred.
|
Total
n=16 Participants
Total of all reporting groups
|
BI 425809 Without Food (R), Then BI 425809 With Food (T)
n=8 Participants
Two period crossover, with participants receiving the treatments in the following order:
BI 425809 without food (R) - Period 1: single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, after an overnight fast of, at least, 10 hours.
BI 425809 with food (T) - Period 2: single dose of one 10 mg film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 mL of water, 30 minutes after a high-fat, high-calorie meal.
Between each treatment at least a 14 day washout period occurred.
|
|---|---|---|---|
|
Age, Continuous
|
35.9 Years
STANDARD_DEVIATION 11.8 • n=22 Participants
|
37.1 Years
STANDARD_DEVIATION 10.1 • n=151 Participants
|
38.3 Years
STANDARD_DEVIATION 8.8 • n=129 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=22 Participants
|
9 Participants
n=151 Participants
|
5 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=22 Participants
|
7 Participants
n=151 Participants
|
3 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=22 Participants
|
16 Participants
n=151 Participants
|
8 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=22 Participants
|
16 Participants
n=151 Participants
|
8 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: From within 2 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 47, 71, 119, 167 and 215 hours after BI 425809 administration.Population: Pharmacokinetic (PK) parameter analysis set: All subjects who were treated with at least one dose of BI 425809 and who provide at least one 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. One subject from the BI 425809 without food (R) group was excluded due to abnormal BI 425809 values prior to its administration.
This outcome measured the area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) following its administration in fed and fasted state. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
BI 425809 Without Food (R)
n=15 Participants
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, after an overnight fast of, at least, 10 hours.
|
BI 425809 With Food (T)
n=15 Participants
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, 30 minutes after a high-fat, high-calorie meal.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
4026.21 hour*nanomol/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
4614.38 hour*nanomol/liter
Standard Error NA
Adjusted geometric standard error = 1.09
|
PRIMARY outcome
Timeframe: From within 2 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 47, 71, 119, 167 and 215 hours after BI 425809 administration.Population: Pharmacokinetic (PK) parameter analysis set: All subjects who were treated with at least one dose of BI 425809 and who provide at least one 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. One subject from the BI 425809 without food (R) group was excluded due to abnormal BI 425809 values prior to its administration.
This outcome measured the maximum measured concentration of BI 425809 in plasma (Cmax) following its administration in fed and fasted state. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
BI 425809 Without Food (R)
n=15 Participants
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, after an overnight fast of, at least, 10 hours.
|
BI 425809 With Food (T)
n=15 Participants
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, 30 minutes after a high-fat, high-calorie meal.
|
|---|---|---|
|
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
|
120.24 nanomol/liter
Standard Error NA
Adjusted geometric standard error = 1.05
|
142.28 nanomol/liter
Standard Error NA
Adjusted geometric standard error = 1.05
|
SECONDARY outcome
Timeframe: From within 2 hours prior and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 47, 71, 119, 167 and 215 hours after BI 425809 administration.Population: Pharmacokinetic (PK) parameter analysis set: All subjects who were treated with at least one dose of BI 425809 and who provide at least one 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. One subject from the BI 425809 without food (R) group was excluded due to abnormal BI 425809 values prior to its administration. Only subjects with evaluable data were included in the analysis.
This outcome measured area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following its administration in fed and fasted state. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' will be considered as random, whereas the other effects will be considered as fixed.
Outcome measures
| Measure |
BI 425809 Without Food (R)
n=15 Participants
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, after an overnight fast of, at least, 10 hours.
|
BI 425809 With Food (T)
n=14 Participants
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, 30 minutes after a high-fat, high-calorie meal.
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
3906.73 hour*nanomol/liter
Standard Error NA
Adjusted geometric standard error = 1.06
|
4468.36 hour*nanomol/liter
Standard Error NA
Adjusted geometric standard error = 1.06
|
Adverse Events
BI 425809 Without Food (R)
BI 425809 With Food (T)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 425809 Without Food (R)
n=16 participants at risk
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, after an overnight fast of, at least, 10 hours.
|
BI 425809 With Food (T)
n=15 participants at risk
Participants received a single dose of one 10 milligrams (mg) film-coated tablet of BI 425809 (Iclepertin) in the intended commercial formulation, administered orally with 240 milliliters (mL) of water, 30 minutes after a high-fat, high-calorie meal.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.7%
1/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.7%
1/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 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
|
31.2%
5/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
20.0%
3/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Paraesthesia
|
6.2%
1/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Psychiatric disorders
Depressed mood
|
6.2%
1/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 days.
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
|
13.3%
2/15 • All-cause mortality: From BI 425809 administration until individual end of study for each of the interventions, up to 22 days. Adverse event reporting: From BI 425809 administration until the end of the residual effect period for each of the interventions, up to 11 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