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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503783-16-00 | Registry Identifier | CTIS (EU) |
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The main objective of this trial is to investigate the effect on the exposure of BI 1815368 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1815368 (Reference, R) then BI 1815368 + Itraconazole (Test, T) | Experimental | Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R. On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1815368 | Drug | BI 1815368 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. | Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration. |
| Maximum Measured Concentration of BI 1815368 in Plasma (Cmax) | Maximum measured concentration (Cmax) of BI 1815368 in plasma is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1815368 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. |
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Inclusion Criteria:
Exclusion Criteria:
Further exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | 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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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist 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.
This study was an open-label, single-center, two-period, fixed-sequence trial in healthy male subjects.
Each subject participated in two treatment periods (Days -3 to 4 in Period 1 and Days -3 to 7 in Period 2) and received the Reference treatment (R) in Period 1 and the Test treatment (T) in Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1815368 (R), Then Itraconazole and BI 1815368 (T) | Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R. On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Reference Treatment R) |
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| Washout Period |
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| Period 2 (Test Treatment T) |
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The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1815368 (R), Then Itraconazole and BI 1815368 (T) | Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R. On Days -3 to 6/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole with 240 mL of water after an overnight fast of at least 9 hours once daily for 9 days (9 doses in total). On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T. The BI 1815368 single doses of Treatments R (Visit 2) and T (Visit 3) were separated by a washout period of at least 7 days. |
| 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 BI 1815368 Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. | Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of a PK endpoint or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value for one period to the statistical assessment. Only subjects with available PK data were included in this analysis. | Posted | Geometric Least Squares Mean | Standard Error | nanomoles*hour/Liter (nmol*h/L) | Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration. |
BI 1815368 alone: From drug administration of BI 1815368 in period 1 until 4 days after treatment administration. Itraconazole alone: From first drug administration of itraconazole in period 2 until drug administration of BI 1815368, up to 4 days. BI 1815368 and itraconazole: From first drug administration of BI 1815368 in period 2 until 8 days after last treatment administration of itraconazole in period 2, up to 14 days. All-cause mortality was recorded until end of trial, up to 23 days.
The treated set (TS) included all subjects who were treated with at least one dose of trial drug. The treated set was used for safety analyses.
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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 1815368 (R) Alone | Subjects were administered during Period 1 on Day 1/Visit 2 a single oral dose of BI 1815368 tablet with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (h) as reference treatment R. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | 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 | Jun 12, 2023 | Apr 20, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2023 | Mar 24, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Participants cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).
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| Itraconazole |
| Drug |
Itraconazole |
|
|
| Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 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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| Primary | Maximum Measured Concentration of BI 1815368 in Plasma (Cmax) | Maximum measured concentration (Cmax) of BI 1815368 in plasma is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of a PK endpoint or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value for one period to the statistical assessment. Only subjects with available PK data were included in this analysis. | Posted | Geometric Least Squares Mean | Standard Error | nanomoles/Liter (nmol/L) | Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration. |
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| Secondary | Area Under the Concentration-time Curve of BI 1815368 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. Geometric least squares mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance model (ANOVA) on the logarithmic scale. The pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included 'subjects' as a random effect and treatment as a fixed effect. These quantities were then back transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. | Pharmacokinetic (PK) parameter analysis set (PKS) included all subjects in the TS who provided at least one PK endpoint and were not excluded due to a protocol deviation relevant to the evaluation of a PK endpoint or due to PK non-evaluability. Thus, a subject was included in the PKS even if he contributed only one PK parameter value for one period to the statistical assessment. Only subjects with available PK data were included in this analysis. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | Within 3 hours prior to and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 34, 47, and 71 hours for both periods, and additionally at 95, 119 and 143 hours for Period 2 after BI 1815368 administration. |
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| 0 |
| 14 |
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Itraconazole Alone | On Day -3 to Day -1/Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole (3 doses in total), once daily with 240 mL of water after an overnight fast of at least 10 hours. | 0 | 14 | 0 | 14 | 2 | 14 |
| EG002 | Itraconazole and BI 1815368 (T) | On Days 1 to 6 /Visit 3 of Period 2, subjects were administered a 20 mL (200 mg) oral solution of itraconazole (6 doses in total) with 240 ml of water after an overnight fast of at least 9 hours. On Day 1/Visit 3 of this period, they received a single oral dose of BI 1815368 tablet with 240 mL of water following an overnight fast of at least 10 hours (h). This combined treatment constituted the test treatment T. | 0 | 13 | 0 | 13 | 4 | 13 |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| D010879 |
| Piperazines |
| Other |
No formal hypothesis was tested. |
| Other |
No formal hypothesis was tested. |