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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503046-50-00 | Other Identifier | CTIS |
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The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A inducer carbamazepine on the pharmacokinetics of a single dose of BI 1810631 in plasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zongertinib Alone (Reference)/ Zongertinib+Carbamazepine (Test) | Experimental | Participants took a single 60 mg oral dose of Zongertinib after fasting overnight (reference period). In the test period, they took the same Zongertinib dose after 18 days of daily Carbamazepine pretreatment, with doses increasing from 200 mg to 600 mg. They continued taking 600 mg of Carbamazepine daily for 6 days after the Zongertinib dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zongertinib | Drug | Participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours. |
| 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 adjusted 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. | One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration. |
| Maximum Measured Concentration of Zongertinib in Plasma (Cmax) | Maximum measured concentration of Zongertinib in plasma (Cmax). Geometric least square mean (adjusted geometric mean) and adjusted 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. | One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after 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). Geometric least square mean (adjusted geometric mean) and adjusted 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | 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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A total of 16 participants entered the trial after being screened for eligibility, ensuring they met all inclusion and none of the exclusion criteria. They were allocated to the same treatment sequence to receive 2 treatments in a fixed order (R-T). All 16 received the first treatment (R), and 15 received the second (T). One participant did not start the second treatment due to a positive drug test result but completed the follow-up visit and was not considered to have prematurely discontinued.
The trial was an open-label, two-treatment, two-period, fixed-sequence crossover trial in healthy male Participants comparing the test treatment (T) with the reference treatment (R). Treatment R consisted of one single oral dose of 60 mg zongertinib as a film-coated tablet alone. Treatment T consisted of one single oral dose of 60 mg zongertinib as a film-coated tablet with multiple oral doses of carbamazepine, titrated from 200 mg once daily (q.d.) to 400 mg q.d., then to 600 mg q.d.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zongertinib Alone (Reference)/ Zongertinib+Carbamazepine (Test) | Zongertinib Alone: In the reference treatment period, participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours. Zongertinib + Carbamazepine: In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Reference Treatment Period (R) |
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| Washout |
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| Period 2: Test Treatment Period (T) |
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Treated set (TS): The treated set includes all participants who were treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zongertinib Alone (Reference)/ Zongertinib+Carbamazepine (Test) | Zongertinib Alone: In the reference treatment period, participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours. Zongertinib + Carbamazepine: In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration. |
| 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-∞). Geometric least square mean (adjusted geometric mean) and adjusted 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. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provided at least one 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 * nanomole / liter (h*nmol/L) | One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration. |
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AE collected: Zongertinib : Up to 14 days after the first Zongertinib administration. Zongertinib + Carbamazepine loading: From Day -18 to Day -12 in Period 2, 6 days. Carbamazepine loading: Carbamazepine loading: From Day -12 to Day 1 in Period 2 (second administration on zongertinib), 12 days. Zongertinib + Carbamazepine: Up to 14 days after the second Zongertinib administration. All cause-mortality: up to 48 days
Treated set (TS): The treated set includes all subjects who were treated with at least one dose of Zongertinib.
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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 | Participants were administered a single dose of 60 milligrams (mg) of Zongertinib film-coated tablet orally on Day 1 of Visit 2 with 240 milliliters (mL) of water after an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | 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 | Sep 14, 2023 | Oct 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2024 | Oct 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Carbamazepine | Drug | Participants received increasing doses of Carbamazepine once daily as extended-release tablets with 240 mL of water for 18 days, starting at 200 mg, then 400 mg, and finally 600 mg. Afterward, they continued taking 600 mg of Carbamazepine once daily for 6 days. |
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| One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration. |
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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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| OG000 |
| Zongertinib Alone (Reference, R) |
In the reference treatment period (Period 1), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form following an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. |
| OG001 | Zongertinib+Carbamazepine (Test, T) | In the test treatment period (Period 2), participants were administered a single oral dose of 60 milligrams (mg) of Zongertinib in tablet form after an overnight fast of at least 10 hours, with 240 milliliters (mL) of water. This followed 18 days of pretreatment with increasing doses of Carbamazepine, starting at 200 mg, then 400 mg, and finally 600 mg, administered once daily as extended-release tablets with 240 mL of water. Additionally, subjects continued to receive 600 mg of Carbamazepine once daily for 6 days following Zongertinib administration. |
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| Primary | Maximum Measured Concentration of Zongertinib in Plasma (Cmax) | Maximum measured concentration of Zongertinib in plasma (Cmax). Geometric least square mean (adjusted geometric mean) and adjusted 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. | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provided at least one 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 | nanomole / liter (nmol/L) | One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration. |
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| 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). Geometric least square mean (adjusted geometric mean) and adjusted 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 | Pharmacokinetic parameter analysis set (PKS): This set includes all participants in the treated set (TS) who provided at least one 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 * nanomole / liter (h*nmol/L) | One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration. |
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| 0 |
| 16 |
| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Zongertinib+Carbamazepine Loading | Participants took 200 mg of carbamazepine after dinner for 4 days, followed by 400 mg after dinner for 2 days. | 0 | 15 | 0 | 15 | 7 | 15 |
| EG002 | Carbamazepine Loading | Participants took 400 mg of carbamazepine after dinner for 5 days, followed by 600 mg after dinner for 7 days. | 0 | 15 | 0 | 15 | 11 | 15 |
| EG003 | Zongertinib+Carbamazepine | Participants took 600 mg of carbamazepine in the evening after dinner for 6 days. They also took a single dose of a 60 mg Zongertinib film-coated tablet in the morning on Day 1 of Visit 3, after an overnight fast of at least 10 hours. | 0 | 15 | 0 | 15 | 5 | 15 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Faeces hard | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 26.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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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.