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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000874-42 | EudraCT Number | EudraCT |
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Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 2 (part 3) | Experimental | low dose dabigatran + high dose ticagrelor |
|
| Test 1 (part 1 + 2) | Active Comparator | high dose ticagrelor |
|
| Reference 1 (part 1 + 2) | Experimental | medium dose dabigatran |
|
| Reference 2 (part 3) | Experimental | low dose dabigatran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | medium dose dabigatran |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran. | -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours |
| Total Dabigatran: Maximum Measured Concentration (Cmax) | Maximum measured concentration of total dabigatran in plasma, per period. | -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug Related Adverse Events | The number of participants with drug related adverse events | From screening until the end-of-study examination |
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Inclusion criteria:
Healthy male subjects
Exclusion criteria:
Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.141.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate 220 mg - Part 1 | A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test. |
| FG001 | Ticagrelor 180 mg - Part 1 | A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ticagrelor |
| Drug |
high dose ticagrelor |
|
| Ticagrelor | Drug | high dose ticagrelor |
|
| dabigatran etexilate | Drug | low dose dabigatran |
|
| dabigatran etexilate | Drug | medium dose dabigatran |
|
| FG002 | Dabigatran Etexilate 220 mg - Part 2 | A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test. |
| FG003 | Ticagrelor 180 mg - Part 2 | A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test |
| FG004 | Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3 | A randomised, two-period, cross-over trial, the two treatments administered were
Between treatment periods there was a washout period of at least 4 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran Etexilate 220 mg - Part 1 | A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test. |
| BG001 | Ticagrelor 180 mg - Part 1 | A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test. |
| BG002 | Dabigatran Etexilate 220 mg - Part 2 | A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test. |
| BG003 | Ticagrelor 180 mg - Part 2 | A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test |
| BG004 | Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3 | A randomised two-period cross-over trial, the two treatments administered were
Between treatment periods there was a washout period of at least 4 days. |
| BG005 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) | Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran. | Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours |
|
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| |||||||||||||||||||||||||||||||
| Primary | Total Dabigatran: Maximum Measured Concentration (Cmax) | Maximum measured concentration of total dabigatran in plasma, per period. | Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours |
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| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Drug Related Adverse Events | The number of participants with drug related adverse events | Treated set | Posted | Number | participants | From screening until the end-of-study examination |
|
3 to 10 days after last dosing
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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 | Dabigatran Etexilate 220 mg - Part 1 | A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test. | 0 | 8 | 1 | 8 | ||
| EG001 | Ticagrelor 180 mg - Part 1 | A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test. | 0 | 4 | 0 | 4 | ||
| EG002 | Dabigatran Etexilate 220 mg - Part 2 | A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test. | 0 | 8 | 0 | 8 | ||
| EG003 | Ticagrelor 180 mg - Part 2 | A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test | 0 | 4 | 0 | 4 | ||
| EG004 | Dabi 75 mg - Part 3 | A single dose of dabigatran etexilate (Dabi) 75 mg | 0 | 12 | 2 | 12 | ||
| EG005 | Multiple Dose Ticagrelor - Part 3 | Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4. | 0 | 12 | 3 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal infection | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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| Male |
|
| Participants |
|
|
A single dose of Dabigatran etexilate 75 mg |
| OG005 | Dabigatran + Ticagrelor - Part 3 | Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4. |
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