HealthyPhase 1NCT01595854
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
A Phase 1 study testing dabigatran etexilate and Ticagrelor in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods 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
- 36 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Jun 2012
- 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
- Healthy male subjects
Who cannot join
- Any relevant deviation from healthy conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
- 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
medium dose dabigatran
TicagrelorDrug
high dose ticagrelor
TicagrelorDrug
high dose ticagrelor
dabigatran etexilateDrug
low dose dabigatran
dabigatran etexilateDrug
medium dose dabigatran
| Study group | Role | What they receive |
|---|---|---|
| Test 2 (part 3) | Experimental | low dose dabigatran + high dose ticagrelor Receives: Drug: Ticagrelor; Drug: dabigatran etexilate |
| Test 1 (part 1 + 2) | Active comparator | high dose ticagrelor Receives: Drug: Ticagrelor |
| Reference 1 (part 1 + 2) | Experimental | medium dose dabigatran Receives: Drug: dabigatran etexilate |
| Reference 2 (part 3) | Experimental | low dose dabigatran Receives: Drug: dabigatran etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: -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.
Measured: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Secondary outcomes (1)
Number of Participants With Drug Related Adverse Events
The number of participants with drug related adverse events
Measured: From screening until the end-of-study examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595854
- Sponsor's protocol ID
- 1160.141
- Other IDs
- 2012-000874-42
- Status last verified
- Jun 2013
- First submitted
- 9 May 2012
- Last updated
- 22 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01595854
- Acronym / sponsor ID
- 1160.141
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Posted 22 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test 2 (part 3) | Experimental | Drug: Ticagrelor, Drug: dabigatran etexilatelow dose dabigatran + high dose ticagrelor |
| Test 1 (part 1 + 2) | Active comparator | Drug: Ticagrelorhigh dose ticagrelor |
| Reference 1 (part 1 + 2) | Experimental | Drug: dabigatran etexilatemedium dose dabigatran |
| Reference 2 (part 3) | Experimental | Drug: dabigatran etexilatelow dose dabigatran |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects
Key exclusion criteria (1 listed)
- 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 etexilatemedium dose dabigatran | Drug | Reference 1 (part 1 + 2) |
| Ticagrelorhigh dose ticagrelor | Drug | Test 1 (part 1 + 2) |
| Ticagrelorhigh dose ticagrelor | Drug | Test 2 (part 3) |
| dabigatran etexilatelow dose dabigatran | Drug | Reference 2 (part 3) |
| dabigatran etexilatemedium dose dabigatran | Drug | Test 2 (part 3) |
Primary outcome
Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.
Total Dabigatran: Maximum Measured Concentration (Cmax)
Time frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Maximum measured concentration of total dabigatran in plasma, per period.
1 secondary outcome
Number of Participants With Drug Related Adverse Events
Time frame: From screening until the end-of-study examination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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 22 Aug 2013. 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 22 Aug 2013). 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 (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞) (time frame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 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?
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 22 Aug 2013.