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The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 764198 (C-14) (approach 1) | Experimental |
| |
| BI 764198 (C-14) (approach 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 764198 (C-14) (approach 1) | Drug | BI 764198 (C-14) (approach 1) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces. | Urine: Within 2 hours before drug administration, and at 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. Feces: up to 48 hours (feces) before drug administration, and at 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. If warranted, further 24-hour collections at trial site were performed at 365-389, 533-557-, and 701-725-hours post-administration depending on participants fulfilling the radioactivity recovery criteria. | Urine and feces sample collection: 48 hours before and up to 725 hours after drug administration. The details are mentioned in the description section. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz, Area Under the Concentration-time Curve of [14C]-BI 764198-EQ Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of [14C]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | 9728 NZ | Netherlands |
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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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An additional cohort (2b) was introduced due to errors in plasma samples from the first 8 participants in cohort 2a, preventing reliable metabolite profiling. Cohort 2b received the same treatment to enable proper profiling. The assessment schedule for cohort 2b was abbreviated, release criteria were not applied, and data from cohorts 2a and 2b were pooled for analysis. The sample size for the microtracer approach was doubled compared to the classical ADME approach.
This open-label, non randomised, single-dose, single-period, two-arm phase I trial investigates the mass balance, metabolism, and pharmacokinetics of a single dose of BI 764198 in healthy males. Study arm 1 uses a classical hADME approach, while study arm 2 uses a microtracer approach and is divided into two cohorts (2a and 2b). Participants were allocated in a 1:2 ratio based on availability.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Classical hADME | Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours. |
| FG001 | Cohort 2: Microtracer hADME | Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Cohort 1: Classical hADME | Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours. |
| BG001 |
| 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 | Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces. | Urine: Within 2 hours before drug administration, and at 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. Feces: up to 48 hours (feces) before drug administration, and at 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. If warranted, further 24-hour collections at trial site were performed at 365-389, 533-557-, and 701-725-hours post-administration depending on participants fulfilling the radioactivity recovery criteria. | Pharmacokinetic (PK) Analysis Set (PKS): Participants in the treated set (TS) with at least one primary or secondary PK endpoint, excluding those with protocol deviations affecting PK evaluation or non-evaluable data. One participant in Cohort 1 did not collect all urine and feces samples, urine data for one participant in Cohort 2 were also excluded due to incomplete collection. As per protocol, only the initial 8 subjects in Cohort 2 (2a) were included in the primary endpoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage of dose excreted | Urine and feces sample collection: 48 hours before and up to 725 hours after drug administration. The details are mentioned in the description section. |
AE collection period: From drug administration until 4 days after drug administration. All-cause mortality: From drug administration up to 31 days after drug administration.
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 | Cohort 1: Classical hADME | Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 3.7 Megabecquerel (MBq). The substance was taken orally with 240 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 |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 26.1 | Systematic Assessment |
An additional cohort (2b) was introduced due to errors in plasma samples from the first 8 participants in cohort 2a, preventing reliable metabolite profiling. Cohort 2b received the same treatment to enable proper profiling. The assessment schedule for cohort 2b was abbreviated, release criteria were not applied, and data from cohorts 2a and 2b were pooled for analysis.
| 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 | Aug 10, 2023 | Apr 30, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2023 | May 7, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
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| BI 764198 (C-14) (approach 2) |
| Drug |
BI 764198 (C-14) (approach 2) |
|
| Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
| AUC0-tz, Area Under the Concentration-time Curve of BI 764198 Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. | Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
| Cmax, Maximum Measured Concentration of [14C]-BI 764198-EQ in Plasma After Single Oral Administration of [14C]BI 76418. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of [14C]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form. This standardization ensures that the data can be accurately compared to the unlabeled BI 764198. | Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
| Cmax, Maximum Measured Concentration of BI 76418 in Plasma After Single Oral Administration of [14C]BI 76418. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. | Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
| Cohort 2: Microtracer hADME |
Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after 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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| Secondary | AUC0-tz, Area Under the Concentration-time Curve of [14C]-BI 764198-EQ Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of [14C]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form. | Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours * nanomoles per liter (h*nmol/L) | Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
|
|
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| Secondary | AUC0-tz, Area Under the Concentration-time Curve of BI 764198 Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. | Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours * nanomoles per liter (h*nmol/L) | Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
|
|
|
| Secondary | Cmax, Maximum Measured Concentration of [14C]-BI 764198-EQ in Plasma After Single Oral Administration of [14C]BI 76418. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. The measurements of [14C]-BI 764198-EQ concentration is adjusted or standardized to reflect a "bioequivalent" form. This standardization ensures that the data can be accurately compared to the unlabeled BI 764198. | Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles per liter (nmol/L) | Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
|
|
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| Secondary | Cmax, Maximum Measured Concentration of BI 76418 in Plasma After Single Oral Administration of [14C]BI 76418. | For participants in the cohorts 1 and 2a, further samples were collected at 365, 533, and 701 hours only if [14C]-radioactivity in plasma post 216 hours after drug administration exceeded the quantification limit at two consecutive points. | Pharmacokinetic (PK) parameter analysis set (PKS): Participants in the treated set (TS) with at least 1 primary or secondary pharmacokinetic (PK) endpoint who were not excluded due to a protocol deviation relevant to the evaluation of PK or PK non-evaluability. Due to errors in plasma samples from the first 8 subjects in cohort 2a, cohort 2b was introduced for reliable metabolite profiling bringing the total number of participants in this cohort to 16 as against the 8 participants in cohort 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/L) | Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration. |
|
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|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Cohort 2a: Microtracer hADME | Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG002 | Cohort 2b: Microtracer hADME | Participants received a single dose of 40 milligrams (mg) of BI 764198 in 10 milliliters (ml) of solution, containing a radioactive dose of 0.1 Megabecquerel (MBq). The substance was taken orally with 240 ml of water after an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 5 | 8 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Erythema marginatum | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Peripheral coldness | Vascular 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.