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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002792-18 | EudraCT Number |
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The main objective of this trial is to assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI 1323495 by investigating the relative bioavailability following single dose administration under fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Treatment | Experimental | fed |
|
| Reference Treatment | Experimental | fasted |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1323495, | Drug | single oral doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point | Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA. | Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration |
| Maximum Measured Concentration of BI 1323495 in Plasma | Maximum measured concentration of BI 1323495 in plasma (Cmax). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA. | Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity | Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA. |
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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 |
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 trial was performed as a randomized, open-label, two-way crossover trial in healthy male subjects in order to compare the test treatment (T) with the reference treatment (R). The treatments were 2 single oral doses of BI 1323495, administered under fasted (R) and fed (T) conditions and separated by a washout period of at least 6 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 Milligram (mg) of BI1323495 Fasted-100 mg of BI1323495 Fed | 2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water 30 minutes after a high-fat, high-calorie meal (fed condition) as a test treatment (T). |
| FG001 | 100 mg of BI1323495 Fed-100 mg of BI1323495 Fasted | 2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water 30 minutes after a high-fat, high-calorie meal as test treatment (T) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water after an overnight fast of at least 10 h as a reference treatment (R). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (P1) + Washout |
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| Treatment Period 2 (P2) |
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Treated set (TS): This subject set included all subjects who were randomised and treated with at least 1 dose of trial drug. The TS was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 Milligram (mg) of BI1323495 Fasted-100 mg of BI1323495 Fed | 2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water 30 minutes after a high-fat, high-calorie meal (fed condition) as a test treatment (T). |
| 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 1323495 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point | Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA. | Pharmacokinetic parameter analysis set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK endpoint that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). | Posted | Geometric Mean | Standard Error | nanomol (nmol) * hours (h) / Litre (L) | Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration |
|
From drug administration until the next drug administration or end of trial, up to 14 days.
Treated set (TS): This subject set included all subjects who were randomised and treated with at least
1 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 1323495 Fed (T) | 100 mg BI 1323495 as a single oral dose under fed conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | 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 | Nov 22, 2018 | Jun 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2019 | Jun 30, 2023 | SAP_001.pdf |
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| Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration |
| NOT COMPLETED |
|
| BG001 | 100 mg of BI1323495 Fed-100 mg of BI1323495 Fasted | 2 film-coated tablets with 50 mg of BI 1323495 (total: 100 mg) was administered as a single oral dose with 240 milliliter (mL) of water 30 minutes after a high-fat, high-calorie meal as test treatment (T) followed by a wash-out period of at least 6 days followed by 2 film-coated tablets with 50 mg of BI 1323495 (total: 100mg) administered as a single oral dose with 240 mL of water after an overnight fast of at least 10 h as a reference treatment (R). |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BI 1323495 Fed (T) |
100 mg BI 1323495 as a single oral dose under fed conditions. |
| OG001 | BI 1323495 Fasted (R) | 100 mg BI 1323495 as a single oral dose under fasted conditions. |
|
|
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| Primary | Maximum Measured Concentration of BI 1323495 in Plasma | Maximum measured concentration of BI 1323495 in plasma (Cmax). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA. | PK parameter analysis set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK endpoint that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). | Posted | Geometric Mean | Standard Error | nanomol (nmol) / Litre (L) | Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration |
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|
|
| Secondary | Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity | Area under the concentration-time curve of BI 1323495 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for sequence, subjects nested within sequences, period, and treatment. Confidence intervals were calculated based on the residual error from the ANOVA. | PK parameter analysis set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK endpoint that was not excluded (due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability). | Posted | Geometric Mean | Standard Error | nanomol (nmol) * hours (h) / Litre (L) | Within 2 hours before and then 20 minutes (min), 40 min, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72 and 96 hours after drug administration |
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| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | BI 1323495 Fasted (R) | 100 mg BI 1323495 as a single oral dose under fasted conditions. | 0 | 12 | 0 | 12 | 3 | 12 |
| Otitis externa | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Mouth injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
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