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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001194-24 | EudraCT Number |
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The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to [C-14]-BI 425809 administered as intravenous microtracer (Reference, R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 425809 (T) BI 425809 mixed with [C-14]-BI 425809 (R) | Experimental | All healthy participants received one unlabelled oral dose of 25 milligram (mg) BI 425809 in the film coated tablet (Test treatment, T) and in addition an intravenous (iv) micro-tracer infusion of 30 microgram (μg) BI 425809 (14-C) (Reference treatment, R), consisting of 27 μg unlabelled BI 425809 mixed with 3 μg labelled [C-14]-BI 425809 in 10 milliliter (mL) iv solution at a concentration of 3 μg BI 425809 (C-14)/ mL. Both treatments were given in the fasted state on the same study day. The reference treatment started 4 hour (h) after administration of the test treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 425809 | Drug | One 25 mg film coated tablet administered with 240 milliliters of water after an overnight fast of at least 10 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of the Analyte ([14C]-BI 425809 After iv Administration as Well as for BI 425809 After Oral Administration) Over the Time Interval From 0 to Infinity (AUC0-∞, Norm) | The dose-normalised area under the concentration-time curve of the analyte ([14C]-BI 425809 after iv administration as well as for BI 425809 after oral administration) over the time interval from 0 to infinity (AUC0-∞, norm) is presented. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model performed on the logarithmic scale, including 'formulation' as a fixed effect and 'subject' as a random effect. For treatment T, pharmacokinetic samples were collected within 2 h prior to the drug administration and at 1, 2, 3, 4.083, 6, 8, 12, 24, 72, 120 and at 168 h after single oral administration of unlabelled BI 425809. For treatment R, samples were collected at 3, 4.083, 4.167, 4.25, 4.5, 5, 6, 7, 8, 12, 16, 24, 72, 120 and 168 h after single oral administration of unlabelled BI 425809. | Pharmacokinetic samples were collected within 2 h before and up to 168 h after single oral administration of unlabelled BI 425809. Further details are in description. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of the BI 425809 in Plasma After a Single Oral Dose (Cmax) | Cmax, maximum measured concentration of the BI 425809 in plasma after a single oral dose is presented. | Pharmacokinetic samples were collected within 2:00 h:m prior to the drug administration and at 1:00, 2:00, 3:00, 4:05, 6:00, 8:00, 12:00, 24:00, 72:00, 120:00 and at 168:00 h:m after drug administration. |
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Inclusion Criteria:
Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 65 years (incl.)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Subjects who are sexually active must use, with their partner, highly effective contraception from the time of administration of trial medication until 4 months after administration of trial medication. Adequate methods are:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34936055 | Derived | Burkard U, Desch M, Shatillo Y, Wunderlich G, Mack SR, Schlecker C, Teitelbaum AM, Liu P, Chan TS. The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [14C]-BI 425809 in Healthy Males. Clin Drug Investig. 2022 Jan;42(1):87-99. doi: 10.1007/s40261-021-01111-9. Epub 2021 Dec 22. |
| 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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All participants were screened for eligibility to participate in the trial. Participants attended specialist site which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be administered to trial treatment if any one of the specific entry criteria were not met.
It was an open-label, non-randomized, single period, single arm Phase I trial in healthy participants. All participants received a single dose of 25 milligram (mg) unlabelled BI 425809 tablet plus a single intravenous (iv) micro-tracer infusion of 30 microgram (μg) BI 425809 (C-14), containing 27 μg BI 425809 mixed with 3 μg [C-14]-BI 425809.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 425809 (T) BI 425809 Mixed With [C-14]-BI 425809 (R) | All healthy participants received one unlabelled oral dose of 25 milligram (mg) BI 425809 in the film coated tablet (Test treatment, T) and in addition an intravenous (iv) micro-tracer infusion of 30 microgram (μg) BI 425809 (14-C) (Reference treatment, R), consisting of 27 μg unlabelled BI 425809 mixed with 3 μg labelled [C-14]-BI 425809 in 10 milliliter (mL) iv solution at a concentration of 3 μg BI 425809 (C-14)/ mL. Both treatments were given in the fasted state on the same study day. The reference treatment started 4 hour (h) after administration of the test treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Treated set (TS): All participants who were randomized and received at least one dose of the trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 425809 (T) BI 425809 Mixed With [C-14]-BI 425809 (R) | All healthy participants received one unlabelled oral dose of 25 milligram (mg) BI 425809 in the film coated tablet (Test treatment, T) and in addition an intravenous (iv) micro-tracer infusion of 30 microgram (μg) BI 425809 (14-C) (Reference treatment, R), consisting of 27 μg unlabelled BI 425809 mixed with 3 μg labelled [C-14]-BI 425809 in 10 milliliter (mL) iv solution at a concentration of 3 μg BI 425809 (C-14)/ mL. Both treatments were given in the fasted state on the same study day. The reference treatment started 4 hour (h) after administration of the test treatment. |
| 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 the Analyte ([14C]-BI 425809 After iv Administration as Well as for BI 425809 After Oral Administration) Over the Time Interval From 0 to Infinity (AUC0-∞, Norm) | The dose-normalised area under the concentration-time curve of the analyte ([14C]-BI 425809 after iv administration as well as for BI 425809 after oral administration) over the time interval from 0 to infinity (AUC0-∞, norm) is presented. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model performed on the logarithmic scale, including 'formulation' as a fixed effect and 'subject' as a random effect. For treatment T, pharmacokinetic samples were collected within 2 h prior to the drug administration and at 1, 2, 3, 4.083, 6, 8, 12, 24, 72, 120 and at 168 h after single oral administration of unlabelled BI 425809. For treatment R, samples were collected at 3, 4.083, 4.167, 4.25, 4.5, 5, 6, 7, 8, 12, 16, 24, 72, 120 and 168 h after single oral administration of unlabelled BI 425809. | Pharmacokinetic (PK) set (PKS): All participants in the treated set (TS) who provided at least one primary or secondary PK endpoint not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Least Squares Mean | Standard Error | Nanomole*hour/Liter/mg (nmol*h/L/mg) | Pharmacokinetic samples were collected within 2 h before and up to 168 h after single oral administration of unlabelled BI 425809. Further details are in description. |
Adverse events: from first drug administration until 11 days after the last administration of BI 425809, up to 12 days. All-cause mortality: from first drug administration until end of trial, up to 15 days.
Treated set (TS): All participants who were randomized and received at least one dose of the trial medication.
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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 425809 (T) BI 425809 Mixed With [C-14]-BI 425809 (R) | All healthy participants received one unlabelled oral dose of 25 milligram (mg) BI 425809 in the film coated tablet (Test treatment, T) and in addition an intravenous (iv) micro-tracer infusion of 30 microgram (μg) BI 425809 (14-C) (Reference treatment, R), consisting of 27 μg unlabelled BI 425809 mixed with 3 μg labelled [C-14]-BI 425809 in 10 milliliter (mL) iv solution at a concentration of 3 μg BI 425809 (C-14)/ mL. Both treatments were given in the fasted state on the same study day. The reference treatment started 4 hour (h) after administration of the test treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | 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 | Jan 7, 2019 | Mar 2, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2019 | Feb 27, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000634404 | BI 425809 |
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| [C-14]-BI 425809 | Drug | Intravenous micro-tracer infusion of 30 μg BI 425809 (14-C) administered 4 hours after treatment T. |
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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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| Secondary | Maximum Measured Concentration of the BI 425809 in Plasma After a Single Oral Dose (Cmax) | Cmax, maximum measured concentration of the BI 425809 in plasma after a single oral dose is presented. | PKS | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole/Liter (nmol/L) | Pharmacokinetic samples were collected within 2:00 h:m prior to the drug administration and at 1:00, 2:00, 3:00, 4:05, 6:00, 8:00, 12:00, 24:00, 72:00, 120:00 and at 168:00 h:m after drug administration. |
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| 0 |
| 6 |
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| 6 |
| 3 |
| 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Visual brightness | Eye disorders | MedDRA 21.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 21.1 | 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.