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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004245-33 | EudraCT Number |
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The main objectives of this trial are to investigate the relative bioavailabilities of rosuvastatin (Reference 1, Part 1) and dabigatran (Reference 2, Part 2) given alone and together with BI 1323495 (Test 1, Test 2) following oral administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference 1 (R1) | Experimental |
| |
| Test 1 (T1) | Experimental |
| |
| Reference 2 (R2) | Experimental |
| |
| Test 2 (T2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Tablet |
| |
| Rosuvastatin + BI 1323495 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
| Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax) | Maximum measured concentration of the analyte (rosuvastatin) in plasma (Cmax). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
| Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. |
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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: https://www.mystudywindow.com/msw/datasharing
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All participants were entered/randomized for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all inclusion and none of the exclusion criteria. Subjects were not to be assigned to treatment groups if any one of the specific entry criteria were violated.
An open, single-dose, randomised, two-period, two way crossover design in each trial part to evaluate the relative bioavailability of rosuvastatin (Part 1) and dabigatran (Part 2) given alone and together with BI 1323495 in healthy male subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Rosuvastatin (R1) / Rosuvastatin + BI 1323495 (T1) | In part 1 (Reference (R1)- Test (T1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 1 (R1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 1 (T1). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (+ Washout Period) |
|
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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 22, 2020 | Jun 30, 2023 |
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| Drug |
Tablets |
|
| Dabigatran etexilate | Drug | Capsule |
|
| Dabigatran etexilate + BI 1323495 | Drug | Capsule and tablets |
|
| Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
| Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax) | Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
| Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
| Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
| FG001 | Part 1: Rosuvastatin + BI 1323495 (T1) / Rosuvastatin (R1) | In part 1 (Test (T1)- Reference (R1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 1 (T1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was administered with 240 mL of water after a standardised breakfast as reference treatment 1 (R1). |
| FG002 | Part 2: Dabigatran (R2) / Dabigatran + BI 1323495 (T2) | In part 2 (Reference (R2)- Test 2 (T2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 mg dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 2 (T2). |
| FG003 | Part 2: Dabigatran + BI 1323495 (T2) / Dabigatran (R2) | In part 2 (Test 2 (T2) - Reference (R2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 2 (T2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2). |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
|
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Rosuvastatin (R1) / Rosuvastatin + BI 1323495 (T1) | In part 1 (Reference (R1)- Test (T1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 1 (R1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 1 (T1). |
| BG001 | Part 1: Rosuvastatin + BI 1323495 (T1) / Rosuvastatin (R1) | In part 1 (Test (T1)- Reference (R1)), on trial day 1 of period 1, a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 1 (T1). Period 1 is followed by a washout period of at least 7 days. In part 1, on trial day 1 of period 2, a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was administered with 240 mL of water after a standardised breakfast as reference treatment 1 (R1). |
| BG002 | Part 2: Dabigatran (R2) / Dabigatran + BI 1323495 (T2) | In part 2 (Reference (R2)- Test 2 (T2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 mg dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test treatment 2 (T2). |
| BG003 | Part 2: Dabigatran + BI 1323495 (T2) / Dabigatran (R2) | In part 2 (Test 2 (T2) - Reference (R2)), on trial day 1 of period 1, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 milliliter (mL) of water after a standardised breakfast as test treatment 2 (T2). Period 1 is followed by a washout period of at least 7 days. In part 2, on trial day 1 of period 2, a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference treatment 2 (R2). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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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| 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 | Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. | All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS:All subjects in the treated set 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. Rosuvastatin:AUC0-∞ only calculated for 12 subjects, due for 2 subjects concentrations at last sampling point were higher than at preceding time point. | Posted | Geometric Least Squares Mean | Standard Error | Hours * nanogramm / milliliter | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
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| Primary | Part 1: Maximum Measured Concentration of the Analyte (Rosuvastatin) in Plasma (Cmax) | Maximum measured concentration of the analyte (rosuvastatin) in plasma (Cmax). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. | All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanogramm / milliliter | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
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| Primary | Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. | All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set 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. | Posted | Geometric Least Squares Mean | Standard Error | Hours * nanogramm / milliliter | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
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| Primary | Part 2: Maximum Measured Concentration of the Analyte (Dabigatran) in Plasma (Cmax) | Maximum measured concentration of the analyte (dabigatran) in plasma (Cmax) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. | All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set 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. | Posted | Geometric Least Squares Mean | Standard Error | Nanogramm / milliliter | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
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| Secondary | Part 1: Area Under the Concentration-time Curve of the Analyte (Rosuvastatin) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte (rosuvastatin) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Rosuvastatin (Reference 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. Rosuvastatin + BI 1323495 (Test 1) was measured within 3 hours (h) before drug administration and 1h, 2h, 3h, 3h 30 minutes (min) 4h, 4h 30min, 5h, 5h 30min, 6h, 7h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration. | All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set 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. | Posted | Geometric Least Squares Mean | Standard Error | Hours * nanogramm / milliliter | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
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| Secondary | Part 2: Area Under the Concentration-time Curve of the Analyte (Dabigatran) in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) | Area under the concentration-time curve of the analyte (dabigatran) in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) Dabigatran (Reference 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. Dabigatran + BI 1323495 (Test 2) was measured within 3 hours (h) before drug administration and 30 minutes (min), 1h, 1h 30 min, 2h, 2h 30 min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 47h and 71h after drug administration. | All subjects included in the Pharmacokinetic (PK) parameter analysis set (PKS) and with available data for this endpoint. PKS: All subjects in the treated set 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. | Posted | Geometric Least Squares Mean | Standard Error | Hours * nanogramm / milliliter | Measured within 3 hours (h) before and up to 95h after drug administration. Detailed time frame is in description section. |
|
From the time of administration of test or reference treatment until administration time of next study drug dose or until 0:00 h on day 7 after time of administration, whatever occurs first, up to 7 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosuvastatin (Part 1, Reference 1) | In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 milligram (mg) rosuvastatin was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 1 (R1). | 0 | 14 | 0 | 14 | 4 | 14 |
| EG001 | Rosuvastatin + BI 1323495 (Part 1, Test 1) | In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1). | 0 | 14 | 0 | 14 | 5 | 14 |
| EG002 | Dabigatran (Part 2, Reference 2) | In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was administered with 240 milliliter (mL) of water after a standardised breakfast as reference 2 (R2). | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Dabigatran + BI 1323495 (Part 2, Test 2) | In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 2 (T2). | 0 | 14 | 0 | 14 | 1 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2020 | Jun 30, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1).
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| Dabigatran + BI 1323495 (Part 2, Test 2) |
In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 2 (T2). |
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In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 2 (T2).
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| OG001 |
| Rosuvastatin + BI 1323495 (Part 1, Test 1) |
In part 1 on study Day 1 of Period 1 or 2 a single oral dose of 1 film-coated tablet of 10 mg rosuvastatin was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 1 (T1). |
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| OG001 |
| Dabigatran + BI 1323495 (Part 2, Test 2) |
In part 2 on study Day 1 of Period 1 or 2 a single oral dose of 1 hard capsule of 75 milligram (mg) dabigatran etexilate was coadministered with a single oral dose of 6 film-coated tablets of 50 mg BI 1323495 (300 mg in total) with 240 mL of water after a standardised breakfast as test 2 (T2). |
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