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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001934-28 | EudraCT Number | EudraCT |
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To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 409306 fasted | Experimental | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition. |
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| BI 409306 fed | Experimental | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition. |
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| BI 409306 at bed-time | Experimental | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 409306 | Drug | film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration of BI 409306 in Plasma (Cmax) | Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C | Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h |
| Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz) | AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C | Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) | AUC0-infinity is the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1289.22.1 Boehringer Ingelheim Investigational Site | Berlin | 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: https:// www.mystudywindow.com/msw/datatransparency
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All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that the subject met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.
Eighteen healthy subjects were entered and treated and completed the planned observation time. All 18 subjects received study medication (open-label) under fasted (Treatment A) and fed (Treatment B) conditions in a two-way crossover fashion followed by a fixed sequence administered at bed time (Treatment C).
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 409306 Fasted/Fed/Bed Time | Single oral dose of 25 milligram (mg) BI 409306 film-coated tablet, with 240 millilitre (ml) water in the morning under fasted then under fed condition and last administered at bed-time with a washout period of at least 3 days between the administrations. |
| FG001 | BI 409306 Fed/Fasted/Bed Time | Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fed then under fast condition and last administered at bed-time with a washout period of at least 3 days between the administrations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Fasted or Fed) |
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| Period 2 (Fasted or Fed) |
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| Period 3 (Bed-time) |
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The treated set (TS): This set included all subjects who received at least one dose of trial medication. It was used for the analysis of safety, demographic data, baseline characteristics, and disposition. The TS included all 18 subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 409306 Fasted/Fed/Bed Time | Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fasted then under fed condition and last administered at bed-time with a washout period of at least 3 days between the administrations. |
| BG001 | BI 409306 Fed/Fasted/Bed Time |
| 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 | Maximum Measured Concentration of BI 409306 in Plasma (Cmax) | Cmax is the maximum measured concentration of BI 409306 in plasma. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C | The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole per litre | Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h |
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From first administration of BI 409306 up to 24 hours thereafter for each treatment period.
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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 409306 Fasted | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | 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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| ID | Term |
|---|---|
| C000630656 | BI 409306 |
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| Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h |
| NOT COMPLETED |
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| NOT COMPLETED |
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Single oral dose of 25 mg BI 409306 film-coated tablet, with 240 ml water in the morning under fed then under fast condition and last administered at bed-time with a washout period of at least 3 days between the administrations. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | BI 409306 Fasted | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fasted condition. |
| OG001 | BI 409306 Fed | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition. |
| OG002 | BI 409306 at Bed-time | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time |
|
|
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| Primary | Area Under the Concentration-time Curve of BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-tz) | AUC0-tz is the area under the concentration-time curve of the BI 409306 in plasma from time 0 to time of last quantifiable data point. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C | The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour times nanomole per litre | Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h |
|
|
|
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| Secondary | Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) | AUC0-infinity is the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. More detailed time frame information: 1 hour (h) before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment A/B; 1h before administration of BI 409306 and 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00 h after administration of BI 409306 at treatment C. | The Pharmacokinetic set (PKS): This set included all treated subjects who provided at least one observation for at least one primary endpoint without important protocol violations with respect to the statistical evaluation of PK endpoints. All 18 subjects were included in the PKS. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hour times nanomole per litre | Treatment A/B: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h; treatment C: -1:00, 0:10, 0:20, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00h |
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | BI 409306 Fed | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water in the morning under fed condition. | 0 | 18 | 0 | 18 | 4 | 18 |
| EG002 | BI 409306 at Bed-time | Single dose 25 mg BI 409306 film-coated tablet, oral administration with 240 ml water at bed-time | 0 | 18 | 0 | 18 | 1 | 18 |
| Feeling hot | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Bladder discomfort | Renal and urinary disorders | MedDRA 17.1 | 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.
| No formal hypothesis was tested. | Ratio (Bed time/Fasted) | 94.88 | Standard Error of the Mean | 19.1 | 2-Sided | 90 | 85.028 | 105.875 | The estimated parameter was the adjusted geometric mean ratios [%] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation [%]. | Other | The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed. |
| No formal hypothesis was tested. | Ratio (Bed time/Fasted) | 94.92 | Standard Error of the Mean | 19.1 | 2-Sided | 90 | 85.061 | 105.921 | The estimated parameter was the adjusted geometric mean ratios [%] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation [%]. | Other | The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed. |