Trial Outcomes & Findings for A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food (NCT NCT06075277)
NCT ID: NCT06075277
Last Updated: 2025-09-22
Results Overview
Area under the concentration-time curve of Zongertinib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least square mean (adjusted geometric mean) and 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. These quantities will then be back-transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
COMPLETED
PHASE1
16 participants
Within 3 hours before Zongertinib administration, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours following administration.
2025-09-22
Participant Flow
This was an open-label, randomized, two-way crossover design trial. Healthy males received a single oral dose of 240 mg Zongertinib (BI 1810631) in its intended commercial formulation (iCF) following an overnight fast and after a standardized high-calorie, high-fat meal. There was a washout period of 14 days between doses. The primary objective was to evaluate how Zongertinib is absorbed when taken with and without food, to determine differences in its bioavailability between these states.
All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment sequence if any of the entry criteria were violated.
Participant milestones
| Measure |
Zongertinib iCF Fasted (Reference (R)) /Zongertinib iCF Fed (Test (T))
Two period crossover separated by a wash-out of at least 14 days:
Period 1: Participants received a single oral dose of 240 milligram (mg) of Zongertinib as film coated tablets (4x 60 mg tablets) following an overnight fast of at least 10 hours.
Period 2: Participants received a single oral dose of 240 milligram (mg) Zongertinib as film coated tablets (4x 60 mg tablet) following a high fat/high calorie meal.
|
Zongertinib iCF Fed (Test (T)) / Zongertinib iCF Fasted (Reference (R))
Two period crossover separated by a wash-out of at least 14 days:
Period 1: Participants received a single oral dose of 240 milligram (mg) Zongertinib as film coated tablets (4x 60 mg tablet) following a high fat/high calorie meal.
Period 2: Participants received a single oral dose of 240 milligram (mg) of Zongertinib as film coated tablets (4x 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
|
Period 1
COMPLETED
|
8
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
8
|
8
|
|
Washout Period
COMPLETED
|
8
|
8
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
8
|
8
|
|
Period 2
COMPLETED
|
8
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Test How Zongertinib is Taken up in the Body When Taken With or Without Food
Baseline characteristics by cohort
| Measure |
Zongertinib iCF Fasted (Reference (R)) /Zongertinib iCF Fed (Test (T))
n=8 Participants
Two period crossover separated by a wash-out of at least 14 days:
Period 1: Participants received a single oral dose of 240 milligram (mg) of Zongertinib as film coated tablets (4x 60 mg tablets) following an overnight fast of at least 10 hours.
Period 2: Participants received a single oral dose of 240 milligram (mg) Zongertinib as film coated tablets (4x 60 mg tablet) following a high fat/high calorie meal.
|
Zongertinib iCF Fed (Test (T)) / Zongertinib iCF Fasted (Reference (R))
n=8 Participants
Two period crossover separated by a wash-out of at least 14 days:
Period 1: Participants received a single oral dose of 240 milligram (mg) Zongertinib as film coated tablets (4x 60 mg tablet) following a high fat/high calorie meal.
Period 2: Participants received a single oral dose of 240 milligram (mg) of Zongertinib as film coated tablets (4x 60 mg tablets) following an overnight fast of at least 10 hours.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
45.9 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
47.9 years
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours before Zongertinib administration, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours following administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and received at least one dose of trial medication and 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 Zongertinib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least square mean (adjusted geometric mean) and 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. These quantities will then be back-transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Outcome measures
| Measure |
Zongertinib iCF Fed (Test (T))
n=16 Participants
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following a high-fat, high-calorie meal.
|
Zongertinib iCF Fasted (Reference (R))
n=16 Participants
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
59457.92 hour*nanomol/Liter (h*nmol/L)
Standard Error NA
Geometric standard error = 1.07
|
46951.21 hour*nanomol/Liter (h*nmol/L)
Standard Error NA
Geometric standard error = 1.07
|
PRIMARY outcome
Timeframe: Within 3 hours before Zongertinib administration, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours following administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and received at least one dose of trial medication and 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 Zongertinib in plasma (Cmax). Geometric least square mean (adjusted geometric mean) and 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. These quantities will then be back-transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Outcome measures
| Measure |
Zongertinib iCF Fed (Test (T))
n=16 Participants
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following a high-fat, high-calorie meal.
|
Zongertinib iCF Fasted (Reference (R))
n=16 Participants
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Measured Concentration of the Zongertinib in Plasma (Cmax)
|
4666.87 nanomol/Liter (nmol/L)
Standard Error NA
Geometric standard error = 1.09
|
3700.37 nanomol/Liter (nmol/L)
Standard Error NA
Geometric standard error = 1.09
|
SECONDARY outcome
Timeframe: Within 3 hours before Zongertinib administration, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours following administration.Population: Pharmacokinetic parameter analysis set (PKS): all subjects who were randomised and received at least one dose of trial medication and 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 Zongertinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least square mean (adjusted geometric mean) and 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. These quantities will then be back-transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.
Outcome measures
| Measure |
Zongertinib iCF Fed (Test (T))
n=16 Participants
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following a high-fat, high-calorie meal.
|
Zongertinib iCF Fasted (Reference (R))
n=16 Participants
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
59986.25 hour*nanomol/Liter (h*nmol/L)
Standard Error NA
Geometric standard error = 1.07
|
47594.57 hour*nanomol/Liter (h*nmol/L)
Standard Error NA
Geometric standard error = 1.07
|
Adverse Events
Zongertinib 240mg iCF Fed (T)
Zongertinib 240mg iCF Fast (R)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zongertinib 240mg iCF Fed (T)
n=16 participants at risk
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following a high-fat, high-calorie meal.
|
Zongertinib 240mg iCF Fast (R)
n=16 participants at risk
Participants received a single oral dose of 240 milligrams (mg) of Zongertinib as film-coated tablets (4 x 60 mg tablets) following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
General disorders
Pain
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: 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 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: 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
Myalgia
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
18.8%
3/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: 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
Cough
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: 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
Nasal congestion
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: 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 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: 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
Erythema
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: 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 lesion
|
6.2%
1/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
0.00%
0/16 • Serious Adverse Events and other adverse events: From first Zongertnib dose up to 14 days. All-cause mortality: From first trial drug administration up to 22 days
Population description: Treated set (TS)- The treated set includes all subjects who were treated with at least one dose of trial drug.
|
Additional Information
Results disclosure agreements
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- Publication restrictions are in place
Restriction type: OTHER