Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503047-17-00 | Registry Identifier | CTIS | |
| U1111-1291-2883 | Registry Identifier | WHO registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Part A - the primary objective is to assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces after oral single dose administration of BI 1810631 (C-14) (test treatment T1) in healthy male subjects.
Part A - the secondary objective is to assess concentrations of BI 1810631 and [14C]-radioactivity in plasma.
Part B - the primary objective is to investigate the absolute bioavailability of BI 1810631 administered as film-coated tablet (test treatment T2, not radio-labelled) compared with BI 1810631 (C-14) (reference treatment R) administered as intravenous microtracer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - zongertinib (C-14) (T1) | Experimental | Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 [T1]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq). |
|
| Part B - zongertinib (T2), then zongertinib (C-14) (R) | Experimental | Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 [T2]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment [R]) via intravenous infusion. The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zongertinib (C-14) | Drug | Oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Fraction Excreted in Urine and Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe0-tz) | Mass balance and total recovery of [14C]-radioactivity: fraction excreted in urine and faeces given as percentage of the administered oral dose of zongertinib (assessed by [14C]zongertinib-equivalent[EQ]) over the time interval from 0 to the last quantifiable time point (feurine, 0-tz; fefaeces, 0-tz) is reported. Timeframe (continued): after 336 h, if warranted, 24 h collections were to be performed every 7 days on days 21, 28, 35, and 42. Sampling was stopped when the release criteria for radioactivity recovery were met (earliest stopping on Day 15). | Within 18 h (urine) or 48 h (faeces) before drug intake; at 0-4, 4-8, 8-12, 12-24 (urine); and at 24 h sampling intervals until 336 h after drug intake (both). Both: after 336 h, every 7 days, up to day 42. Continues in description. |
| Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞,Norm) | The dose-normalised area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞,norm) after oral administration of zongertinib, and after intravenous administration of [14C]zongertinib, is reported. 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 PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Maximum Measured Concentration of Zongertinib in Plasma (Cmax) | Maximum measured concentration of zongertinib in plasma (Cmax) is reported. | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
| Part A - Maximum Measured Concentration of [14C]-Radioactivity (Assessed by [14C]Zongertinib-EQ) in Plasma (Cmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41348300 | Derived | Grempler R, Joseph D, Gan G, Auclair AM, Tiessen RG, Maw HH, Laux R, Wind S, Roessner PM, Sadrolhefazi B, Muller F, Minich D. Absorption, Metabolism, Distribution and Excretion (ADME) and Absolute Bioavailability Assessment of Zongertinib in Healthy Male Volunteers. Clin Drug Investig. 2026 Feb;46(2):115-125. doi: 10.1007/s40261-025-01509-9. Epub 2025 Dec 5. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a 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.
Part A was an open-label, single-arm, single-dose part to investigate the pharmacokinetics of zongertinib and [14C]-radioactivity following one oral dose of zongertinib (C-14) containing a radioactive dose of approximately 3.7 Megabecquerel (MBq).
Part B was an open-label, single-arm, single-period part to compare zongertinib administered orally to the intravenous infusion 2 hours later of zongertinib (C-14) solution (radioactive dose was approximately 0.03 MBq).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part A - Zongertinib (C-14) (T1) | Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 [T1]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq). |
| FG001 | Part B - Zongertinib (T2), Then Zongertinib (C-14) (R) | Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 [T2]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment [R]) via intravenous infusion. The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A - Zongertinib (C-14) (T1) | Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 [T1]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Part A - Fraction Excreted in Urine and Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe0-tz) | Mass balance and total recovery of [14C]-radioactivity: fraction excreted in urine and faeces given as percentage of the administered oral dose of zongertinib (assessed by [14C]zongertinib-equivalent[EQ]) over the time interval from 0 to the last quantifiable time point (feurine, 0-tz; fefaeces, 0-tz) is reported. Timeframe (continued): after 336 h, if warranted, 24 h collections were to be performed every 7 days on days 21, 28, 35, and 42. Sampling was stopped when the release criteria for radioactivity recovery were met (earliest stopping on Day 15). | Pharmacokinetic (PK) parameter analysis set (PKS) restricted to Part A included all part A subjects in the 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 | Geometric Coefficient of Variation | Percentage of the administered dose | Within 18 h (urine) or 48 h (faeces) before drug intake; at 0-4, 4-8, 8-12, 12-24 (urine); and at 24 h sampling intervals until 336 h after drug intake (both). Both: after 336 h, every 7 days, up to day 42. Continues in description. |
From the time of drug administration (part A), or of first drug administration (part B), up to 14 days. All-cause mortality: from first drug administration until the end of trial, up to approximately 6 (part A) or 3 (part B) weeks.
Treated set (TS) included all subjects who were treated with at least one dose of trial drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A - Zongertinib (C-14) (T1) | Healthy male subjects were administered a single oral dose of radioactively-labelled zongertinib (C-14) as a solution (test treatment 1 [T1]) with 240 milliliter (mL) of water, after an overnight fast of at least 10 hours (h). The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance, and zongertinib, i.e. unlabeled ("cold") drug substance, and it contained a radioactive dose of approximately 3.7 Megabecquerel (MBq). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impetigo | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2023 | Sep 23, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2023 | Sep 1, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| zongertinib | Drug | Film-coated tablet |
|
|
| zongertinib (C-14) | Drug | Solution for infusion |
|
|
Maximum measured concentration of [14C]-radioactivity (assessed by [14C]zongertinib-EQ) in plasma (Cmax) is reported. |
| Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
| Part A - Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz) | Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) is reported. | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
| Part A - Area Under the Concentration-time Curve of [14C]-Radioactivity (Assessed by [14C]Zongertinib-EQ) in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz) | Area under the concentration-time curve of [14C]-radioactivity (assessed by [14C]zongertinib-EQ) in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) is reported. | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
| Part B - Dose-normalised Maximum Measured Concentration in Plasma (Cmax,Norm) | The dose-normalised maximum measured concentration in plasma (Cmax,norm) after oral administration of zongertinib, and after intravenous administration of [14C]zongertinib, is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration. |
| Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz,Norm) | The dose-normalised area under the concentration-time curve in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz,norm) after oral administration of zongertinib, and after intravenous administration of [14C]zongertinib, is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration. |
| BG001 | Part B - Zongertinib (T2), Then Zongertinib (C-14) (R) | Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 [T2]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment [R]) via intravenous infusion. The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞,Norm) | The dose-normalised area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞,norm) after oral administration of zongertinib, and after intravenous administration of [14C]zongertinib, is reported. 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 PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | PKS restricted to Part B included all part B subjects in the 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 Least Squares Mean | Standard Error | hour*millimole/Liter/kilogram | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration. |
|
|
|
|
| Secondary | Part A - Maximum Measured Concentration of Zongertinib in Plasma (Cmax) | Maximum measured concentration of zongertinib in plasma (Cmax) is reported. | PKS restricted to Part A included all part A subjects in the 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 | Geometric Coefficient of Variation | nanomole/Liter | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
|
|
|
| Secondary | Part A - Maximum Measured Concentration of [14C]-Radioactivity (Assessed by [14C]Zongertinib-EQ) in Plasma (Cmax) | Maximum measured concentration of [14C]-radioactivity (assessed by [14C]zongertinib-EQ) in plasma (Cmax) is reported. | PKS restricted to Part A included all part A subjects in the 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 | Geometric Coefficient of Variation | nanomole/Liter | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
|
|
|
| Secondary | Part A - Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz) | Area under the concentration-time curve of zongertinib in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) is reported. | PKS restricted to Part A included all part A subjects in the 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 | Geometric Coefficient of Variation | hour*nanomole/Liter | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
|
|
|
| Secondary | Part A - Area Under the Concentration-time Curve of [14C]-Radioactivity (Assessed by [14C]Zongertinib-EQ) in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz) | Area under the concentration-time curve of [14C]-radioactivity (assessed by [14C]zongertinib-EQ) in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) is reported. | PKS restricted to Part A included all part A subjects in the 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 | Geometric Coefficient of Variation | hour*nanomole/Liter | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168, 216, 264, 336 h after drug administration. |
|
|
|
| Secondary | Part B - Dose-normalised Maximum Measured Concentration in Plasma (Cmax,Norm) | The dose-normalised maximum measured concentration in plasma (Cmax,norm) after oral administration of zongertinib, and after intravenous administration of [14C]zongertinib, is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | PKS restricted to Part B included all part B subjects in the 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 Least Squares Mean | Standard Error | picomole/Liter/microgram | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration. |
|
|
|
|
| Secondary | Part B - Dose-normalised Area Under the Concentration-time Curve in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz,Norm) | The dose-normalised area under the concentration-time curve in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz,norm) after oral administration of zongertinib, and after intravenous administration of [14C]zongertinib, is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | PKS restricted to Part B included all part B subjects in the 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 Least Squares Mean | Standard Error | hour*millimole/Liter/kilogram | Within 3 h prior and 0.5, 1, 1.5, 2, 2.5, 3, [zongertinib], 2, 2.08, 2.16, 2.25, 2.5, 2.75, 3, 3.5 [[14C]zongertinib], 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, and 168 h [zongertinib and [14C]zongertinib] after first drug administration. |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | Part B - Zongertinib (T2), Then Zongertinib (C-14) (R) | Healthy male subjects were administered one zongertinib film-coated tablet (test treatment 2 [T2]) orally with 240 mL of water after an overnight fast of at least 10 h. Two hours later, subjects were administered a single solution of radioactively-labelled zongertinib (C-14) (reference treatment [R]) via intravenous infusion. The solution contained a mixture of pure [14C]-labelled zongertinib ("hot") drug substance and zongertinib, i.e. unlabelled ("cold") drug substance, and contained a radioactive dose of approximately 0.03 MBq. | 0 | 7 | 0 | 7 | 2 | 7 |
| Tonsillitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 26.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
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.