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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502860-19-00 | Registry Identifier | CTIS (EU) | |
| U1111-1291-3312 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The main objective of this trial is to investigate the relative bioavailability of a single dose of BI 1810631 intended commercial formulation (iCF) under fed (Test treatment, T) and fasted (Reference treatment, R) conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1810631 (iCF) fed state (Reference, R) then fasting state (Test, T) | Experimental | 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. |
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| BI 1810631 (iCF) fasting state (Test, T) then fed state (Reference, R) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zongertinib | Drug | Participants received a single oral dose of 240 mg Zongertinib (4 x 60 mg tablets) in two periods: in Period 1 after an overnight fast of at least 10 hours, and in Period 2 following a high fat/high calorie meal. |
| 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). 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. | 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. |
| Maximum Measured Concentration of the Zongertinib in Plasma (Cmax) | 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. | 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. |
| 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-∞). 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13627 | 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 sequence if any of the entry criteria were violated.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout Period |
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| Period 2 |
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Treated set (TS): The treated set includes all subjects who were treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 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). 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. | 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. | Posted | Geometric Mean | Standard Error | hour*nanomol/Liter (h*nmol/L) | 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. |
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.
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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 240mg iCF Fed (T) | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 018002430127 | 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 | Nov 13, 2023 | Aug 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2024 | Aug 21, 2025 | SAP_001.pdf |
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two-way crossover
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| 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. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| 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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| ID | Title | Description |
|---|---|---|
| OG000 | Zongertinib iCF Fed (Test (T)) | 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. |
| OG001 | Zongertinib iCF Fasted (Reference (R)) | 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. |
|
|
|
| Primary | Maximum Measured Concentration of the Zongertinib in Plasma (Cmax) | 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. | 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. | Posted | Geometric Mean | Standard Error | nanomol/Liter (nmol/L) | 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. |
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|
|
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| Secondary | 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-∞). 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. | 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. | Posted | Geometric Mean | Standard Error | hour*nanomol/Liter (h*nmol/L) | 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. |
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| 0 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Zongertinib 240mg iCF Fast (R) | 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. | 0 | 16 | 0 | 16 | 7 | 16 |
| Fatigue | General disorders | 26.1 | Systematic Assessment |
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| Pain | General disorders | 26.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | 26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | 26.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
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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.