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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003757-63 | EudraCT Number |
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The main objective of this trial is to investigate the effect of multiple doses of the strong CYP3A inhibitor and recommended P-glycoprotein (P-gp) inhibitor itraconazole on the pharmacokinetics of a single dose of zongertinib in plasma following oral administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zongertinib alone (R) / Zongertinib + itraconazole (T) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zongertinib | Drug | Zongertinib |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | 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. |
| Maximum Measured Concentration of Zongertinib in Plasma (Cmax) | Maximum measured concentration of zongertinib in plasma (Cmax) is reported. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period 1 |
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| Study Period 2 |
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Treated set (TS): The treated set included all participants who were treated with at least one dose of trial drug. The treated set was used for the safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. | 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanomoles * hour per Liter | 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. |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zongertinib Alone | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2023 | Aug 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2023 | Aug 27, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Itraconazole |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Zongertinib + Itraconazole | 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. |
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|
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| Primary | Maximum Measured Concentration of Zongertinib in Plasma (Cmax) | Maximum measured concentration of zongertinib in plasma (Cmax) is reported. | 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanomoles per Liter | 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. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | 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. | 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanomoles * hour per Liter | 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. |
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|
| 0 |
| 16 |
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | Itraconazole Alone | 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). | 0 | 16 | 0 | 16 | 6 | 16 |
| EG002 | Zongertinib + Itraconazole | 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. | 0 | 16 | 0 | 16 | 10 | 16 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA 26.0 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| D010879 |
| Piperazines |