HealthyPhase 1NCT01734772

Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor

A Phase 1 study testing dabigatran etexilate and ticagrelor in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: dabigatran etexilate and ticagrelor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteGermany
Study dates: Nov 2012to Jun 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy male subjects.

Who cannot join

1. Any relevant deviation from healthy conditions.

Trial locations and contacts

1 site in 1 country.

Germany1 site

1160.142.1 Boehringer Ingelheim Investigational Site
Biberach

Other trials in Germany

About this study

Official title: Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects

Conditions: Healthy
Being tested: dabigatran etexilate, ticagrelor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dabigatran etexilateDrug
multiple doses of dabigatran
dabigatran etexilateDrug
medium dose dabigatran
ticagrelorDrug
loading dose of ticagrelor
ticagrelorDrug
multiple doses of ticagrelor
ticagrelorDrug
loading dose of ticagrelor
dabigatran etexilateDrug
single dose of dabigatran

Study groups in NCT01734772
Study group	Role	What they receive
Reference (Part 1/A, Part 2/C)	Experimental	multiple doses of dabigatran (alone) Receives: Drug: dabigatran etexilate
Test 1 (Part 1/Treatment B)	Experimental	concomitant administration of dabigatran and ticagrelor Receives: Drug: dabigatran etexilate; Drug: ticagrelor
Test 2 (Part 2/Treatment D)	Experimental	staggered administration of ticagrelor and dabigatran Receives: Drug: ticagrelor; Drug: dabigatran etexilate

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Jun 2013

First posted28 Nov 2012 (estimated)
Study startNov 2012
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01734772
Sponsor's protocol ID: 1160.142
Other IDs: 2012-002656-16
Status last verified: Apr 2014
First submitted: 15 Nov 2012
Last updated: 5 May 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01734772
Acronym / sponsor ID: 1160.142
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 28 Nov 2012 (estimated)
Results: Posted 5 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Reference (Part 1/A, Part 2/C)	Experimental	Drug: dabigatran etexilatemultiple doses of dabigatran (alone)
Test 1 (Part 1/Treatment B)	Experimental	Drug: dabigatran etexilate, Drug: ticagrelorconcomitant administration of dabigatran and ticagrelor
Test 2 (Part 2/Treatment D)	Experimental	Drug: ticagrelor, Drug: dabigatran etexilatestaggered administration of ticagrelor and dabigatran

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male subjects.

Key exclusion criteria (1 listed)

1. Any relevant deviation from healthy conditions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dabigatran etexilatemultiple doses of dabigatran	Drug	Test 1 (Part 1/Treatment B)
dabigatran etexilatemedium dose dabigatran	Drug	Reference (Part 1/A, Part 2/C)
ticagrelorloading dose of ticagrelor	Drug	Test 1 (Part 1/Treatment B)
ticagrelormultiple doses of ticagrelor	Drug	Test 1 (Part 1/Treatment B)
ticagrelorloading dose of ticagrelor	Drug	Test 2 (Part 2/Treatment D)
dabigatran etexilatesingle dose of dabigatran	Drug	Test 2 (Part 2/Treatment D)

Primary outcome

Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
Time frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).
Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)
Time frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).

Results and safety

Results posted to the registry on 5 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1	24	23
Part 2	24	21

Primary outcome: Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)

Time frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Dabigratan Etexilate 110mg Bid Alone - Part 1 n = 24	Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1 n = 23	Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1 n = 23	Dabigratan Etexilate 110mg Bid Alone - Part 2 n = 23	Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2 n = 21
Value	551 (59.0)	817 (43.3)	689 (55.1)	660 (39.6)	844 (43.4)

Dabigratan Etexilate 110mg Bid Alone - Part 1 vs Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1: geometric Mean Ratio: 149.38 (90% CI 124.388 to 179.383), p = 0.9456, ANOVA
Dabigratan Etexilate 110mg Bid Alone - Part 1 vs Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1: geometric Mean Ratio: 126.47 (90% CI 107.363 to 148.967), p = 0.5481, ANOVA
Dabigratan Etexilate 110mg Bid Alone - Part 2 vs Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2: geometric Mean Ratio: 127.01 (90% CI 108.047 to 149.295), p = 0.5665, ANOVA

Population analysed: 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.

Primary outcome: Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)

Time frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Dabigratan Etexilate 110mg Bid Alone - Part 1 n = 24	Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1 n = 23	Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1 n = 23	Dabigratan Etexilate 110mg Bid Alone - Part 2 n = 23	Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2 n = 21
Value	83.6 (69.3)	136 (45.4)	106 (65.1)	97.6 (46.5)	121 (45.2)

Dabigratan Etexilate 110mg Bid Alone - Part 1 vs Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1: geometric Mean Ratio: 164.74 (90% CI 133.945 to 202.619), p = 0.9841, ANOVA
Dabigratan Etexilate 110mg Bid Alone - Part 1 vs Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1: geometric Mean Ratio: 128.61 (90% CI 106.370 to 155.495), p = 0.6003, ANOVA
Dabigratan Etexilate 110mg Bid Alone - Part 2 vs Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2: gMean Ratio: 123.82 (90% CI 102.695 to 149.288), p = 0.4656, ANOVA

Adverse events

Time frame: 11 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigratan Etexilate 110mg Bid Alone - Part 1	0 of 24 (0%)	0 of 24 (0%)	Not reported
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1	0 of 23 (0%)	0 of 23 (0%)	Not reported
Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1	0 of 23 (0%)	0 of 23 (0%)	Not reported
Dabigratan Etexilate 110mg Bid Alone - Part 2	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2	0 of 21 (0%)	0 of 21 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dabigatran etexilate and ticagrelor in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss) (time frame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01734772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.