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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003630-16 | EudraCT Number |
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The main objective of this trial is to investigate the effect on the exposure of BI 474121 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 |
|---|---|---|---|
| Sequence: BI 474121 alone (Reference) - Itraconazole + BI 474121 (Test) | Experimental | Period 1: Reference (R) treatment: Healthy subjects received a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram (mg)/milliliter (mL) formulation) BI 474121 on day 1 of period 1. Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole for 14 days (days -3 - 11 of period 2) and a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram mg/mL formulation) BI 474121 on day 1 of period 2. BI 474121 administrations in treatment R and treatment T were separated by a wash-out period of at least 10 days. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 or 9 hours before itraconazole administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 474121 | Drug | BI 474121 oral solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect. | Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2. |
| Maximum Measured Concentration of BI 474121 in Plasma (Cmax) | Maximum measured concentration of BI 474121 in plasma (Cmax). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect. | Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect. |
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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, except for the following exclusions:1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
For more details refer to: http://trials.boehringer-ingelheim.com/
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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.
The study was an open-label, two-treatment, two-period, fixed-sequence design trial in healthy male subjects that explored the effect of multiple doses of itraconazole on the single-dose pharmacokinetics of BI 474121.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence: BI 474121 Alone (Reference) - Itraconazole + BI 474121 (Test) | Period 1: Reference (R) treatment: Healthy subjects received a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram (mg)/milliliter (mL) formulation) BI 474121 on day 1 of period 1. Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole for 14 days (days -3 to 11 of period 2) and a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram mg/mL formulation) BI 474121 on day 1 of period 2. BI 474121 administrations in treatment R and treatment T were separated by a wash-out period of at least 10 days. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 or 9 hours before itraconazole administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: BI 474121 Alone (Reference) |
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| Period 2: Itraconazole Alone |
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| Period 2: Itraconazole+BI 474121 (Test) |
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Treated set (TS): The treated set included all subjects who were treated with at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence: BI 474121 Alone (Reference) - Itraconazole + BI 474121 (Test) | Period 1: Reference (R) treatment: Healthy subjects received a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram (mg)/milliliter (mL) formulation) BI 474121 on day 1 of period 1. Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole for 14 days (days -3 to 11 of period 2) and a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram mg/mL formulation) BI 474121 on day 1 of period 2. BI 474121 administrations in treatment R and treatment T were separated by a wash-out period of at least 10 days. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 or 9 hours before itraconazole administration. |
| Units | Counts |
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| 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 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect. | Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of study drug and 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. Only subjects with non-missing values were included in the analyses. | Posted | Geometric Mean | Standard Deviation | hours*nanomole/Liter | Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2. |
R treatment: first administration of BI 474121 until 7 days thereafter. Up to 7 days. T treatment: Itraconazole alone: first administration of itraconazole until time of BI 474121 administration OR until 3 days after last dose of itraconazole. Up to 6 days. T treatment: Itraconazole + BI 474121: BI 474121 administration in treatment period 2 until 3 days after the last administration of itraconazole OR 7 days after the BI 474121 administration in period 2, whatever is later. Up to 14 days.
Treated set (TS): The treated set included all subjects who were treated with at least one dose of study 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 | Reference (R) Treatment: BI 474121 Alone | Period 1: Reference (R) treatment: Healthy subjects received a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram (mg)/milliliter (mL) formulation) BI 474121 on day 1 of period 1. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 001 | 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 | Dec 16, 2020 | Jul 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2021 | Jul 21, 2023 | 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 | Itraconazole oral solution |
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| Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2. |
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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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| ID | Title | Description |
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| OG000 | Reference (R) Treatment: BI 474121 Alone | Period 1: Reference (R) treatment: Healthy subjects received a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram (mg)/milliliter (mL) formulation) BI 474121 on day 1 of period 1. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 administration. |
| OG001 | Test (T) Treatment: Itraconazole + BI 474121 | Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole for 14 days (days -3 to 11 of period 2) and a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram mg/mL formulation) BI 474121 on day 1 of period 2. Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 or 9 hours before itraconazole administration. |
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| Primary | Maximum Measured Concentration of BI 474121 in Plasma (Cmax) | Maximum measured concentration of BI 474121 in plasma (Cmax). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect. | Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of study drug and 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. Only subjects with non-missing values were included in the analyses. | Posted | Geometric Mean | Standard Deviation | Nanomole/Liter | Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2. |
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| Secondary | Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect. | Pharmacokinetic parameter analysis set (PKS): all subjects who were treated with at least one dose of study drug and 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. Only subjects with non-missing values were included in the analyses. | Posted | Geometric Mean | Standard Deviation | Hours*nanomole/Liter | Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 34, 46, 70, 94, 118, 142 hours after BI 474121 administration in each period. In addition at 166, 190, 214, 238, 262 hours after BI 474121 administration in period 2. |
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| 0 |
| 14 |
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| 14 |
| 2 |
| 14 |
| EG001 | Test (T) Treatment: Itraconazole Alone | Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole for 3 days (day -3 to day -1 of period 2). Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 9 hours before itraconazole administration. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Test (T) Treatment: Itraconazole + BI 474121 | Period 2: Test (T) treatment: Healthy subjects received a daily dose of 200 milligram (oral solution, 10 mg/mL) Itraconazole and a single dose of 0.5 milligram (Powder for oral solution, 0.5 milligram mg/mL formulation) BI 474121 on day 1 of period 2. This arm only considers the time when Itraconazole was given together with BI 474121 during period 2 (day 1 to 11 of period 2). Administration of trial medication with 240 mL of water was performed after subjects had fasted overnight; fasting was to start no later than 10 hours before the scheduled dosing of BI 474121 or 9 hours before itraconazole administration. | 0 | 12 | 0 | 12 | 1 | 12 |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| D010879 |
| Piperazines |