Trial Outcomes & Findings for A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers (NCT NCT06360081)

Last Updated: 2025-09-22

Results Overview

Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 to 72h (AUC0-72h) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects within sequences' as a random effect, and sequence, period and treatment as fixed. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

56 participants

Primary outcome timeframe

Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours after administration of zongertinib Test Treatment and zongertinib Reference Treatment.

Results posted on

2025-09-22

Participant Flow

This was an open-label, randomised, single-dose, two-period and two-sequence crossover trial in healthy male and female subjects to compare a test treatment (T) to a reference treatment (R). The test and reference treatments comprised 60 mg zongertinib tablet manufactured by two different manufacturers. Subjects were randomly allocated to the two treatment sequences, namely T-R or R-T (i.e. all subjects received both treatments), with a washout period of at least 14 days 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

Participant milestones
Measure	First Zongertinib Test, Then Zongertinib Reference (T-R) Participants were administered during Period 1 on Day 1 a single oral dose of 60 milligrams (mg) of zongertinib film-coated tablet produced by Manufacturer 1 (Test treatment, T) with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (hrs). Following a washout period of at least 14 days, participants were administered a single oral dose of 60 mg of zongertinib produced by Manufacturer 2 (Reference treatment, R) with 240 mL of water after an overnight fast of at least 10 hrs.	First Zongertinib Reference, Then Zongertinib Test (R-T) Participants were administered during Period 1 on Day 1 a single oral dose of 60 mg of zongertinib film-coated tablet produced by Manufacturer 2 (Reference treatment, R) with 240 ml of water following an overnight fast of at least 10 hrs. Following a washout period of at least 14 days, participants were administered a single oral dose of 60 mg of zongertinib produced by Manufacturer 1 (Test treatment, T) with 240 mL of water after an overnight fast of at least 10 hrs.
Treatment Period 1 (Day 1) STARTED	28	28
Treatment Period 1 (Day 1) COMPLETED	28	28
Treatment Period 1 (Day 1) NOT COMPLETED	0	0
Washout Period (14 Days) STARTED	28	28
Washout Period (14 Days) COMPLETED	28	28
Washout Period (14 Days) NOT COMPLETED	0	0
Treatment Period 2 STARTED	28	28
Treatment Period 2 COMPLETED	28	28
Treatment Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Zongertinib Test, Then Zongertinib Reference (T-R) n=28 Participants Participants were administered during Period 1 on Day 1 a single oral dose of 60 milligrams (mg) of zongertinib film-coated tablet produced by Manufacturer 1 (Test treatment, T) with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (hrs). Following a washout period of at least 14 days, participants were administered a single oral dose of 60 mg of zongertinib produced by Manufacturer 2 (Reference treatment, R) with 240 mL of water after an overnight fast of at least 10 hrs.	First Zongertinib Reference, Then Zongertinib Test (R-T) n=28 Participants Participants were administered during Period 1 on Day 1 a single oral dose of 60 mg of zongertinib film-coated tablet produced by Manufacturer 2 (Reference treatment, R) with 240 ml of water following an overnight fast of at least 10 hrs. Following a washout period of at least 14 days, participants were administered a single oral dose of 60 mg of zongertinib produced by Manufacturer 1 (Test treatment, T) with 240 mL of water after an overnight fast of at least 10 hrs.	Total n=56 Participants Total of all reporting groups
Age, Continuous	32.5 Years STANDARD_DEVIATION 9.0 • n=5 Participants	31.7 Years STANDARD_DEVIATION 7.7 • n=7 Participants	32.1 Years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours after administration of zongertinib Test Treatment and zongertinib Reference Treatment.

Population: Pharmacokinetic (PK) parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 primary or secondary PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Outcome measures

Outcome measures
Measure	Zongertinib Test Treatment (T) n=56 Participants This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 1 (Test Treatment, T).	Zongertinib Reference Treatment (R) n=56 Participants This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 2 (Reference Treatment, R)
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to 72h (AUC0-72h)	13448.03 hours*nanomole/Liter (h·nmol/L) Standard Error NA Adjusted geometric standard error = 1.03	13463.07 hours*nanomole/Liter (h·nmol/L) Standard Error NA Adjusted geometric standard error = 1.03

PRIMARY outcome

Timeframe: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours after administration of zongertinib Test Treatment and zongertinib Reference Treatment.

Maximum measured concentration of zongertinib in plasma (Cmax) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects within sequences' as a random effect, and sequence, period and treatment as fixed. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint.

Outcome measures

Outcome measures
Measure	Zongertinib Test Treatment (T) n=56 Participants This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 1 (Test Treatment, T).	Zongertinib Reference Treatment (R) n=56 Participants This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 2 (Reference Treatment, R)
Maximum Measured Concentration of Zongertinib in Plasma (Cmax)	1135.49 nanomole/Liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.04	1126.11 nanomole/Liter (nmol/L) Standard Error NA Adjusted geometric standard error = 1.04

SECONDARY outcome

Timeframe: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours after administration of zongertinib Test Treatment and zongertinib Reference Treatment.

Time from dosing to maximum measured concentration of zongertinib in plasma (tmax) is reported.

Outcome measures

Outcome measures
Measure	Zongertinib Test Treatment (T) n=56 Participants This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 1 (Test Treatment, T).	Zongertinib Reference Treatment (R) n=56 Participants This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 2 (Reference Treatment, R)
Time From Dosing to Maximum Measured Concentration of Zongertinib in Plasma (Tmax)	2.50 hours (h) Interval 1.0 to 4.0	2.01 hours (h) Interval 1.0 to 4.03

Adverse Events

Zongertinib Test Treatment (T)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Zongertinib Reference Treatment (R)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zongertinib Test Treatment (T) n=56 participants at risk This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 1 (Test Treatment, T).	Zongertinib Reference Treatment (R) n=56 participants at risk This arm included all participants who received a single oral dose of zongertinib tablet (60 mg tablet) produced by Manufacturer 2 (Reference Treatment, R)
Gastrointestinal disorders Diarrhoea	5.4% 3/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.	5.4% 3/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.
Gastrointestinal disorders Nausea	5.4% 3/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.	3.6% 2/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.
General disorders Fatigue	8.9% 5/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.	3.6% 2/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.
Nervous system disorders Headache	14.3% 8/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.	14.3% 8/56 • Serious Adverse Events and Other Adverse Events: From study drug administration until end of the residual effect period (i.e. 14 days), up to 336 hours. All-cause mortality: From drug administration till end of trial, up to 18 days. Treated set (TS): The treated set included all subjects who were treated with at least one dose of the trial drug.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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