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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002656-16 | EudraCT Number | EudraCT |
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To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference (Part 1/A, Part 2/C) | Experimental | multiple doses of dabigatran (alone) |
|
| Test 1 (Part 1/Treatment B) | Experimental | concomitant administration of dabigatran and ticagrelor |
|
| Test 2 (Part 2/Treatment D) | Experimental | staggered administration of ticagrelor and dabigatran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate | Drug | multiple doses of dabigatran |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss). | 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours |
| Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss) | Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss). | 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours |
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Inclusion criteria:
1. Healthy male subjects.
Exclusion criteria:
1. 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 |
|---|---|---|---|---|---|---|
| 1160.142.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 | In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment. |
| FG001 | Part 2 | In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set which includes all subjects who were documented to have received at least 1 dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 | In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss). | Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours |
|
11 days
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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 | Dabigratan Etexilate 110mg Bid Alone - Part 1 | Dabigatran Etexilate 110mg twice daily (bid) for 3 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| dabigatran etexilate |
| Drug |
medium dose dabigatran |
|
| ticagrelor | Drug | loading dose of ticagrelor |
|
| ticagrelor | Drug | multiple doses of ticagrelor |
|
| ticagrelor | Drug | loading dose of ticagrelor |
|
| dabigatran etexilate | Drug | single dose of dabigatran |
|
| BG001 | Part 2 | In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1 | Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid. |
| OG002 | Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1 | Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4. |
| OG003 | Dabigratan Etexilate 110mg Bid Alone - Part 2 | Dabigatran Etexilate 110mg twice daily (bid) for 3 days |
| OG004 | Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2 | Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later. |
|
|
|
| Primary | Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss) | Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss). | Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1 | Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid. | 0 | 23 | 0 | 23 |
| EG002 | Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1 | Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg once on day 4. | 0 | 23 | 0 | 23 |
| EG003 | Dabigratan Etexilate 110mg Bid Alone - Part 2 | Dabigatran Etexilate 110mg twice daily (bid) for 3 days | 0 | 24 | 2 | 24 |
| EG004 | Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2 | Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later. | 0 | 21 | 0 | 21 |
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.
| 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 |
|
| ANOVA |
Adjustment for effects 'subject' and 'treatment'. |
| 0.6003 |
p-value for ratio outside interval 80% - 125% |
| geometric Mean Ratio |
| 128.61 |
| Standard Deviation |
| 39.0 |
| 90 |
| 106.370 |
| 155.495 |
The dispersion value is actually the intraindividual gCV. |
| Yes |
| Non-Inferiority or Equivalence |
Relative bioavailability |
| ANOVA | Adjustment for effects 'subject' and 'treatment'. | 0.4656 | p-value for ratio outside interval 80% - 125% | gMean Ratio | 123.82 | Standard Deviation | 36.9 | 90 | 102.695 | 149.288 | The dispersion value is actually the intraindividual gCV. | Yes | Non-Inferiority or Equivalence | Relative bioavailability |