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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503542-31-00 | Other Identifier | CTIS |
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The main objective of this trial is to investigate the effect on the exposure of BI 1584862 in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as compared to BI 1584862 when given alone as oral single dose (Reference, R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1584862 (R), then BI 1584862 + itraconazole (T) | Experimental | Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1584862 | Drug | One dose with 240 mL of water after an overnight fast of at least 10 h |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) 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 pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | Within 3 to 4 h before and up to 3 days after BI 1584862 administration. |
| Maximum Measured Concentration of BI 1584862 in Plasma (Cmax) | Maximum measured concentration of BI 1584862 in plasma (Cmax) 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 effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | Within 3 to 4 h before and up to 3 days after BI 1584862 administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) 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 effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. |
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Inclusion Criteria:
Exclusion Criteria:
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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 was an open-label, two-period, two-treatment, fixed sequence design trial in healthy male subjects to investigate the effect of itraconazole on the pharmacokinetics of BI 1584862. The trial compared the test treatment (T, BI 1584862 given together with itraconazole) to the reference treatment (R, BI 1584862 given alone) using the fixed sequence R-T.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 1584862 (R), Then BI 1584862 + Itraconazole (T) | Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reference treatment (R) |
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| Test treatment (T) |
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Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 1584862 (R), Then BI 1584862 + Itraconazole (T) | Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 milligram (mg) itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. The two administrations of BI 1584862 were separated by a washout period. |
| 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 1584862 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) 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 pharmacokinetic (PK) endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | Pharmacokinetic (PK) parameter analysis set (PKS): this set included all subjects in the TS who provided at least 1 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 contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | Within 3 to 4 h before and up to 3 days after BI 1584862 administration. |
Adverse events (AEs): from drug administration and/or residual effect period (REP), up to 7 days. Deaths: from drug administration up to 17 days.
Treated set (TS): the treated set included all subjects who were treated with at least 1 dose of trial drug. AEs are reported by treatment and based on the length of the on-treatment period of BI 1584862.
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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 1584862 (R) | Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | 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 | Aug 16, 2023 | May 6, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2023 | May 6, 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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| Itraconazole | Drug | 200 mg daily after an overnight fast of at least 9 h for several consecutive days |
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| Within 3 to 4 h before and up to 3 days after BI 1584862 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 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | BI 1584862 (R) | Reference treatment (R): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. |
| OG001 | BI 1584862 + Itraconazole (T) | Test treatment (T): healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. |
|
|
|
| Primary | Maximum Measured Concentration of BI 1584862 in Plasma (Cmax) | Maximum measured concentration of BI 1584862 in plasma (Cmax) 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 effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | PKS: this set included all subjects in the TS who provided at least 1 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 contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | nanomole/Liter | Within 3 to 4 h before and up to 3 days after BI 1584862 administration. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 1584862 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) 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 effects accounting for the following sources of variation: 'subjects' was considered as a random effect, 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale. | PKS: this set included all subjects in the TS who provided at least 1 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 contributed only 1 PK parameter value for 1 period to the statistical assessment. | Posted | Geometric Least Squares Mean | Standard Error | hour*nanomole/Liter | Within 3 to 4 h before and up to 3 days after BI 1584862 administration. |
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|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Itraconazole Before BI 1584862 (ITZ-1, T) | Healthy male subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days prior to BI 1584862 administration (test treatment, T). | 0 | 14 | 0 | 14 | 3 | 14 |
| EG002 | Itraconazole + BI 1584862 (ITZ+BI, T) | Healthy male subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days. Subjects were additionally administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h (test treatment, T). | 0 | 14 | 0 | 14 | 1 | 14 |
| EG003 | Itraconazole + BI 1584862 (ITZ-2, T) | Healthy male subjects were administered one single dose of BI 1584862 as tablets orally with 240 mL of water after an overnight fast of at least 10 h. Additionally, subjects were administered one daily dose of 200 mg itraconazole as an oral solution after an overnight fast of at least 9 h for several consecutive days (test treatment, T). This arm only reports the adverse events that occurred after the end of the residual effect period of BI 1584862. | 0 | 14 | 0 | 14 | 1 | 14 |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| D010879 |
| Piperazines |
| Other |
| Other |