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The main objective of this trial is to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1291583 (C-14) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1291583 mixed with [C-14] BI 1291583 | Drug | BI 1291583 mixed with radioactive carbon labelled [C-14] BI 1291583 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance and Total Recovery of [14C]-Radioactivity in Urine: Fraction of [14C]-Radioactivity Excreted in Urine Expressed as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (Feurine, 0-tz) | Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine, 0-tz) is reported. Timeframe: After 336h, 24h interval urine sample collection was planned every 7 days starting on Day 21 until Day 43. | Urine sampling intervals: Within 14 hours (h) prior and 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336h after intake of BI 1291583 (C14). Continues in description. |
| Mass Balance and Total Recovery of [14C]-Radioactivity in Faeces: Fraction of [14C]-Radioactivity Excreted in Faeces Expressed as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (Fefaeces, 0-tz) | Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces, 0-tz) is reported. Timeframe: After 336h, 24h interval stools sample collection was planned every 7 days starting on Day 21 until Day 43. | All stools were collected prior and up to 336 hours (h) (sampling intervals 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216 -240, 240-264, 264-288, 288-312, 312-336 h) after intake of BI 1291583 (C14). Continues in description. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of [14C]-Radioactivity ([14C]-BI 1291583-Equivalents (EQ)) in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, [14C]-BI 1291583-EQ) | Area under the concentration-time curve of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, [14C]-BI 1291583-EQ) is reported. |
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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: https://www.mystudywindow.com/msw/datatransparency
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that the subjects strictly met all inclusion and none of the exclusion criteria. Subjects were not to be entered in the trial if any of the entry criteria were violated.
The trial was performed as an open-label, single-arm, single-dose trial in healthy male subjects to investigate the basic PK of BI 1291583, its metabolites (BI 1373234, CD 18507, CD 17849, CD 16785, and BI 1321869 (CD 16426)) and [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 5 mg BI 1291583 (C-14).
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1291583 (C-14) | Participants received a single dose of 20 milliliter (mL) of BI 1291583 (C-14) radioactive solution for oral administration concentrated at 0.25 milligram/mL. The radioactive solution contained a radioactive dose of approximately 0.36 Megabecquerel (MBq). The oral solution contained a mixture of pure radioactive carbon [14C]-labelled "hot" drug substance, and BI 1291583, i.e. unlabelled "cold" drug substance. The BI 1291583 (C-14) oral solution was administered with 240 mL of water after an overnight fast of at least 10 hours (h). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): included all subjects who were treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1291583 (C-14) | Participants received a single dose of 20 milliliter (mL) of BI 1291583 (C-14) radioactive solution for oral administration concentrated at 0.25 milligram/mL. The radioactive solution contained a radioactive dose of approximately 0.36 Megabecquerel (MBq). The oral solution contained a mixture of pure radioactive carbon [14C]-labelled "hot" drug substance, and BI 1291583, i.e. unlabelled "cold" drug substance. The BI 1291583 (C-14) oral solution was administered with 240 mL of water after an overnight fast of at least 10 hours (h). |
| 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 | Mass Balance and Total Recovery of [14C]-Radioactivity in Urine: Fraction of [14C]-Radioactivity Excreted in Urine Expressed as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (Feurine, 0-tz) | Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine, 0-tz) is reported. Timeframe: After 336h, 24h interval urine sample collection was planned every 7 days starting on Day 21 until Day 43. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of administered dose | Urine sampling intervals: Within 14 hours (h) prior and 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336h after intake of BI 1291583 (C14). Continues in description. |
From first administration of BI 1291583 (C14) until the end of the residual effect period, up to 28 days.
Treated set (TS): included 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 | BI 1291583 (C-14) | Participants received a single dose of 20 milliliter (mL) of BI 1291583 (C-14) radioactive solution for oral administration concentrated at 0.25 milligram/mL. The radioactive solution contained a radioactive dose of approximately 0.36 Megabecquerel (MBq). The oral solution contained a mixture of pure radioactive carbon [14C]-labelled "hot" drug substance, and BI 1291583, i.e. unlabelled "cold" drug substance. The BI 1291583 (C-14) oral solution was administered 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 |
|---|---|---|---|---|---|
| Dizziness | Nervous system 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 | Jun 13, 2023 | Dec 22, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2023 | Dec 22, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
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| Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14). |
| Area Under the Concentration-time Curve of BI 1291583 in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, BI 1291583) | Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583) is reported. | Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14). |
| Maximum Measured Concentration of [14C]-Radioactivity ([14C]-BI 1291583-Equivalents (EQ)) in Plasma (Cmax, [14C]-BI 1291583-EQ) | Maximum measured concentration of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma (Cmax, [14C]-BI 1291583-EQ) is reported. | Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14). |
| Maximum Measured Concentration of BI 1291583 in Plasma (Cmax, BI 1291583) | Maximum measured concentration of BI 1291583 in plasma (Cmax, BI 1291583) is reported. | Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14). |
| Area Under the Concentration-time Curve of BI 1291583 Metabolites in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, BI 1291583 Metabolites) | Area under the concentration-time curve of BI 1291583 metabolites in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583 metabolites). AUC0-tz of the following BI 1291583 metabolites is reported: BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869. | Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14). |
| Maximum Measured Concentration of BI 1291583 Metabolites in Plasma (Cmax, BI 1291583 Metabolites) | Maximum measured concentration of BI 1291583 metabolites in plasma (Cmax, BI 1291583 metabolites). Cmax of the following metabolites is reported: BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869. | Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14). |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | BI 1291583 (C-14) | Participants received a single dose of 20 milliliter (mL) of BI 1291583 (C-14) radioactive solution for oral administration concentrated at 0.25 milligram/mL. The radioactive solution contained a radioactive dose of approximately 0.36 Megabecquerel (MBq). The oral solution contained a mixture of pure radioactive carbon [14C]-labelled "hot" drug substance, and BI 1291583, i.e. unlabelled "cold" drug substance. The BI 1291583 (C-14) oral solution was administered with 240 mL of water after an overnight fast of at least 10 hours (h). |
|
|
| Primary | Mass Balance and Total Recovery of [14C]-Radioactivity in Faeces: Fraction of [14C]-Radioactivity Excreted in Faeces Expressed as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (Fefaeces, 0-tz) | Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces, 0-tz) is reported. Timeframe: After 336h, 24h interval stools sample collection was planned every 7 days starting on Day 21 until Day 43. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of administered dose | All stools were collected prior and up to 336 hours (h) (sampling intervals 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216 -240, 240-264, 264-288, 288-312, 312-336 h) after intake of BI 1291583 (C14). Continues in description. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of [14C]-Radioactivity ([14C]-BI 1291583-Equivalents (EQ)) in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, [14C]-BI 1291583-EQ) | Area under the concentration-time curve of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, [14C]-BI 1291583-EQ) is reported. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanomole/Liter (h*nmol/L) | Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14). |
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| Secondary | Area Under the Concentration-time Curve of BI 1291583 in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, BI 1291583) | Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583) is reported. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour * nanomole/Liter (h*nmol/L) | Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14). |
|
|
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| Secondary | Maximum Measured Concentration of [14C]-Radioactivity ([14C]-BI 1291583-Equivalents (EQ)) in Plasma (Cmax, [14C]-BI 1291583-EQ) | Maximum measured concentration of [14C]-radioactivity ([14C]-BI 1291583-EQ) in plasma (Cmax, [14C]-BI 1291583-EQ) is reported. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/L) | Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14). |
|
|
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| Secondary | Maximum Measured Concentration of BI 1291583 in Plasma (Cmax, BI 1291583) | Maximum measured concentration of BI 1291583 in plasma (Cmax, BI 1291583) is reported. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/L) | Within 4 hours prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 hours after administration of BI 1291583 (C14). |
|
|
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| Secondary | Area Under the Concentration-time Curve of BI 1291583 Metabolites in Plasma Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz, BI 1291583 Metabolites) | Area under the concentration-time curve of BI 1291583 metabolites in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz, BI 1291583 metabolites). AUC0-tz of the following BI 1291583 metabolites is reported: BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour *nanomole/Liter (h*nmol/L) | Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14). |
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| Secondary | Maximum Measured Concentration of BI 1291583 Metabolites in Plasma (Cmax, BI 1291583 Metabolites) | Maximum measured concentration of BI 1291583 metabolites in plasma (Cmax, BI 1291583 metabolites). Cmax of the following metabolites is reported: BI 1373234; CD 18507; CD 17849; CD 16785; BI 1321869. | Pharmacokinetic set (PKS): This set included all subjects in the treated (TS) 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. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole/Liter (nmol/L) | Within 4 hours (h) prior and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 120, 168, 216, 264, 336, 485, 653, 821, 989 h after administration of BI 1291583 (C14). |
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| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 26.0 | 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.
| Title | Measurements |
|---|---|
|
| BI 1373234 |
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| BI 1321869 |
|
| Title | Measurements |
|---|---|
|
| BI 1373234 |
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| BI 1321869 |
|