Trial Outcomes & Findings for A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood (NCT NCT05833139)

Last Updated: 2025-09-22

Results Overview

Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Within 3 hours (h) prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 47, 71, 119, 167 h for both periods, and additionally at 191, 215, 239, 263, and 287 h for period 2, after zongertinib administration.

Results posted on

2025-09-22

Participant Flow

This was a non-randomised, open-label, two-treatment, two-period, fixed-sequence crossover trial in healthy men. There was one group of participants, each participant underwent the fixed sequence of Reference (R) followed by Test (T) treatment, with a washout period of ≥14 days between zongertinib (BI 1810631) administrations.

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 group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Zongertinib Alone (R) / Zongertinib + Itraconazole (T) Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2), as reference treatment R. Treatment Period 2: a single oral solution of 200 mg (10 mg/mL in a 20 milliliter (mL) solution) itraconazole was administered once daily over 14 days (\[total: 14 doses\], from Day -3 to Day 11, Period 2). On Day 1 (Day 1, Period 2, Visit 3), 4th day of itraconazole treatment, a single oral dose of 15 mg zongertinib was administered 1 hour (h) after itraconazole administration as test treatment T. The two administrations of zongertinib were separated by a washout interval of at least 14 days. Zongertinib and itraconazole were orally administered with 240 mL of water after an overnight fast of at least 10 h for zongertinib and 9 h for itraconazole.
Study Period 1 STARTED	16
Study Period 1 COMPLETED	16
Study Period 1 NOT COMPLETED	0
Study Period 2 STARTED	16
Study Period 2 COMPLETED	15
Study Period 2 NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Zongertinib Alone (R) / Zongertinib + Itraconazole (T) Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2), as reference treatment R. Treatment Period 2: a single oral solution of 200 mg (10 mg/mL in a 20 milliliter (mL) solution) itraconazole was administered once daily over 14 days (\[total: 14 doses\], from Day -3 to Day 11, Period 2). On Day 1 (Day 1, Period 2, Visit 3), 4th day of itraconazole treatment, a single oral dose of 15 mg zongertinib was administered 1 hour (h) after itraconazole administration as test treatment T. The two administrations of zongertinib were separated by a washout interval of at least 14 days. Zongertinib and itraconazole were orally administered with 240 mL of water after an overnight fast of at least 10 h for zongertinib and 9 h for itraconazole.
Study Period 2 Adverse Event	1

Baseline Characteristics

A Study in Healthy Men to Test How Itraconazole Influences the Amount of Zongertinib (BI 1810631) in the Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zongertinib Alone (R) / Zongertinib + Itraconazole (T) n=16 Participants Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2), as reference treatment R. Treatment Period 2: a single oral solution of 200 mg (10 mg/mL in a 20 milliliter (mL) solution) itraconazole was administered once daily over 14 days (\[total: 14 doses\], from Day -3 to Day 11, Period 2). On Day 1 (Day 1, Period 2, Visit 3), 4th day of itraconazole treatment, a single oral dose of 15 mg zongertinib was administered 1 hour (h) after itraconazole administration as test treatment T. The two administrations of zongertinib were separated by a washout interval of at least 14 days. Zongertinib and itraconazole were orally administered with 240 mL of water after an overnight fast of at least 10 h for zongertinib and 9 h for itraconazole.
Age, Continuous	33.3 Years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 hours (h) prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 47, 71, 119, 167 h for both periods, and additionally at 191, 215, 239, 263, and 287 h for period 2, after zongertinib administration.

Population: Pharmacokinetic (PK) Set (PKS): this set included all participants in the treated set (TS) who provided at least one primary or secondary PK endpoint, and who 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-∞) is reported.

Outcome measures

Outcome measures
Measure	Zongertinib Alone n=16 Participants Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2) with 240 mL of water after an overnight fast of at least 10 hours (h).	Zongertinib + Itraconazole n=16 Participants Treatment Period 2: a single oral solution of 200 mg itraconazole (10 mg/mL in a 20 mL solution) was administered once daily over 14 days (\[total: 14 doses\], from Day -3 to Day 11, Period 2). On Day 1, of the itraconazole treatment (Day 1, Period 2, Visit 3), a single oral dose of 15 mg zongertinib was administered 1 h after itraconazole administration.
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	3014 Nanomoles * hour per Liter Standard Error NA Adjusted Geometric Standard Error = 1.068	4255 Nanomoles * hour per Liter Standard Error NA Adjusted Geometric Standard Error = 1.068

PRIMARY outcome

Population: PKS: this set included all participants in the TS who provided at least one primary or secondary PK endpoint, and who 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) is reported.

Outcome measures

Outcome measures
Measure	Zongertinib Alone n=16 Participants Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2) with 240 mL of water after an overnight fast of at least 10 hours (h).	Zongertinib + Itraconazole n=16 Participants Treatment Period 2: a single oral solution of 200 mg itraconazole (10 mg/mL in a 20 mL solution) was administered once daily over 14 days (\[total: 14 doses\], from Day -3 to Day 11, Period 2). On Day 1, of the itraconazole treatment (Day 1, Period 2, Visit 3), a single oral dose of 15 mg zongertinib was administered 1 h after itraconazole administration.
Maximum Measured Concentration of Zongertinib in Plasma (Cmax)	138 Nanomoles per Liter Standard Error NA Adjusted Geometric Standard Error = 1.094	175 Nanomoles per Liter Standard Error NA Adjusted Geometric Standard Error = 1.094

SECONDARY outcome

Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

Outcome measures

Outcome measures
Measure	Zongertinib Alone n=16 Participants Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2) with 240 mL of water after an overnight fast of at least 10 hours (h).	Zongertinib + Itraconazole n=16 Participants Treatment Period 2: a single oral solution of 200 mg itraconazole (10 mg/mL in a 20 mL solution) was administered once daily over 14 days (\[total: 14 doses\], from Day -3 to Day 11, Period 2). On Day 1, of the itraconazole treatment (Day 1, Period 2, Visit 3), a single oral dose of 15 mg zongertinib was administered 1 h after itraconazole administration.
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	2892 Nanomoles * hour per Liter Standard Error NA Adjusted Geometric Standard Error = 1.071	4130 Nanomoles * hour per Liter Standard Error NA Adjusted Geometric Standard Error = 1.071

Adverse Events

Zongertinib Alone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Itraconazole Alone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Zongertinib + Itraconazole

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zongertinib Alone n=16 participants at risk Treatment Period 1: a single oral dose of 15 milligrams (mg) zongertinib, film-coated tablet, was administered once on Day 1 (Day 1, Period 1, Visit 2) with 240 mL of water after an overnight fast of at least 10 hours (h).	Itraconazole Alone n=16 participants at risk Treatment period 2: a single oral dose of 200 mg itraconazole (10 mg/milliliter (mL) in a 20 mL solution) was administered once daily with 240 mL of water after an overnight fast of 9 hours (h) over 3 days (\[total: 3 doses\], from Day -3 to Day -1, Period 2, Visit 3).	Zongertinib + Itraconazole n=16 participants at risk Treatment Period 2: a single oral solution of 200 mg itraconazole (10 mg/mL in a 20 mL solution) was administered once daily over 11 days (\[total: 11 doses\], from Day 1 to Day 11, Period 2). On Day 1, of the itraconazole treatment (Day 1, Period 2, Visit 3), a single oral dose of 15 mg zongertinib was administered 1h after itraconazole administration.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	18.8% 3/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	31.2% 5/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Gastrointestinal disorders Abdominal pain	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Gastrointestinal disorders Flatulence	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Gastrointestinal disorders Nausea	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Nervous system disorders Headache	18.8% 3/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	12.5% 2/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Skin and subcutaneous tissue disorders Acne	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Eye disorders Diplopia	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Injury, poisoning and procedural complications Hand fracture	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Injury, poisoning and procedural complications Sunburn	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 1/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.	0.00% 0/16 • Zongertinib alone: From the first administration of zongertinib until first administration of itraconazole (IT), up to 14 days. IT alone: From the first administration of itraconazole until 2nd administration of zongertinib, up to 3 days. Zongertinib + IT: From the second administration of zongertinib until 8 days after the last administration of IT, up to 19 days. Treated Set (TS): this set included all participants who were treated with at least one dose of trial drug. The TS was used for safety analyses.

Additional Information

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Boehringer Ingelheim

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Principal investigator is a sponsor employee
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