HealthyPhase 1NCT01306162

Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects

A Phase 1 study testing Dabigatran etexilate plus dronedarone and Dabigatran etexilate 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

The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Dabigatran etexilate plus dronedarone and Dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteGermany
Study dates: Feb 2011to May 2011
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

1. Healthy male and female subjects

Who cannot join

1. Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

Germany1 site

1160.112.1 Boehringer Ingelheim Investigational Site
Ulm

Other trials in Germany

About this study

Official title: Relative Bioavailability of a Single Dose of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Dronedarone Tablet) or in Combination With 400 mg Bid Dronedarone (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Randomised, Four-sequence, Two Period Cross-over, Phase I Study)

Conditions: Healthy
Being tested: Dabigatran etexilate plus dronedarone, Dabigatran etexilate

What participants receive

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

Dabigatran etexilate plus dronedaroneDrug
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose
Dabigatran etexilateDrug
150 mg as single dose
Dabigatran etexilate plus dronedaroneDrug
dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)
Dabigatran etexilate plus dronedaroneDrug
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid
Dabigatran etexilate plus dronedaroneDrug
dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)

Study groups in NCT01306162
Study group	Role	What they receive
A: Dabigatran alone (Reference)	Experimental	Capsule, oral administration with 240 mL water Receives: Drug: Dabigatran etexilate
B: Dabigatran plus Dronedarone (Test)	Experimental	Capsule and Tablets, oral administration with 240 mL water Receives: Drug: Dabigatran etexilate plus dronedarone
C: Dabigatran plus Dronedarone (Test)	Experimental	Capsule and Tablets, oral administration with 240 mL water Receives: Drug: Dabigatran etexilate plus dronedarone
D: Dabigatran plus Dronedarone (Test)	Experimental	Capsule and Tablets, oral administration with 240 mL water Receives: Drug: Dabigatran etexilate plus dronedarone
E: Dabigatran plus Dronedarone (Test)	Experimental	Capsule and Tablets, oral administration with 240 mL water Receives: Drug: Dabigatran etexilate plus dronedarone

What is being measured

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

Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.
Measured: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Total Dabigatran: Maximum Measured Concentration (Cmax)
Maximum measured concentration of total dabigatran in plasma, per period.
Measured: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Secondary outcomes (2)

Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.
Measured: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Free Dabigatran: Maximum Measured Concentration (Cmax)
Maximum measured concentration of free dabigatran in plasma, per period.
Measured: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Timeline

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

Feb 2011May 2011

First posted1 Mar 2011 (estimated)
Study startFeb 2011
Primary completionMay 2011

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01306162
Sponsor's protocol ID: 1160.112
Other IDs: 2010-024009-11
Status last verified: Apr 2014
First submitted: 28 Feb 2011
Last updated: 6 Jun 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of a Single Dose of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Dronedarone Tablet) or in Combination With 400 mg Bid Dronedarone (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Randomised, Four-sequence, Two Period Cross-over, Phase I Study)
ClinicalTrials.gov ID: NCT01306162
Acronym / sponsor ID: 1160.112
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: May 2011 (actual)
First posted: 1 Mar 2011 (estimated)
Results: Posted 14 Aug 2012

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
A: Dabigatran alone (Reference)	Experimental	Drug: Dabigatran etexilateCapsule, oral administration with 240 mL water
B: Dabigatran plus Dronedarone (Test)	Experimental	Drug: Dabigatran etexilate plus dronedaroneCapsule and Tablets, oral administration with 240 mL water
C: Dabigatran plus Dronedarone (Test)	Experimental	Drug: Dabigatran etexilate plus dronedaroneCapsule and Tablets, oral administration with 240 mL water
D: Dabigatran plus Dronedarone (Test)	Experimental	Drug: Dabigatran etexilate plus dronedaroneCapsule and Tablets, oral administration with 240 mL water
E: Dabigatran plus Dronedarone (Test)	Experimental	Drug: Dabigatran etexilate plus dronedaroneCapsule and Tablets, oral administration with 240 mL water

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

1. Healthy male and female 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 etexilate plus dronedaronedabigatran etexilate 150 mg plus dronedarone 400 mg as single dose	Drug	B: Dabigatran plus Dronedarone (Test)
Dabigatran etexilate150 mg as single dose	Drug	A: Dabigatran alone (Reference)
Dabigatran etexilate plus dronedaronedabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)	Drug	C: Dabigatran plus Dronedarone (Test)
Dabigatran etexilate plus dronedaronedabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid	Drug	D: Dabigatran plus Dronedarone (Test)
Dabigatran etexilate plus dronedaronedabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)	Drug	E: Dabigatran plus Dronedarone (Test)

Primary outcome

Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity.
Total Dabigatran: Maximum Measured Concentration (Cmax)
Time frame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Maximum measured concentration of total dabigatran in plasma, per period.

2 secondary outcomes

Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Free Dabigatran: Maximum Measured Concentration (Cmax)
Time frame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration

Results and safety

Results posted to the registry on 14 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TrtA -- TrtB -- TrtD -- TrtE	9	9
TrtA -- TrtC -- TrtE -- TrtD	9	9
TrtB -- TrtD -- TrtE -- TrtA	9	9
TrtC -- TrtE -- TrtD -- TrtA	9	8

Primary outcome: Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)

Time frame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	150mg DE (TrtA) n = 35	150mg DE + 400mg DR (TrtB) n = 18	150mg DE + 400mg DR 2h Later (TrtC) n = 17	150mg DE + 400mg DR Bid Same Time (TrtD) n = 34	150mg DE + 400mg DR Bid 2h Later (TrtE) n = 30
Value	1160 (40.3)	2520 (27.1)	1440 (40.3)	2570 (28.1)	1510 (32.9)

150mg DE (TrtA) vs 150mg DE + 400mg DR (TrtB): Geometric mean ratio TrtB: TrtA (%): 214 (90% CI 191 to 240), p = 1.0000, ANOVA
150mg DE (TrtA) vs 150mg DE + 400mg DR 2h Later (TrtC): Geometric mean ratio TrtC: TrtA (%): 130 (90% CI 112 to 151), p = 0.6697, ANOVA
150mg DE (TrtA) vs 150mg DE + 400mg DR Bid Same Time (TrtD): Geometric mean ratio TrtD: TrtA (%): 236 (90% CI 173 to 321), p = 0.9992, ANOVA

Population analysed: Pharmacokinetic (PK) set defined as all subjects randomised, treated and who provided evaluable data for at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK.

Primary outcome: Total Dabigatran: Maximum Measured Concentration (Cmax)

Measure	150mg DE (TrtA) n = 35	150mg DE + 400mg DR (TrtB) n = 18	150mg DE + 400mg DR 2h Later (TrtC) n = 17	150mg DE + 400mg DR Bid Same Time (TrtD) n = 34	150mg DE + 400mg DR Bid 2h Later (TrtE) n = 30
Value	149 (46.0)	282 (30.1)	166 (37.5)	288 (29.9)	163 (30.9)

150mg DE (TrtA) vs 150mg DE + 400mg DR (TrtB): Geometric mean ratio TrtB: TrtA (%): 187 (90% CI 162 to 215), p = 0.9999, ANOVA
150mg DE (TrtA) vs 150mg DE + 400mg DR 2h Later (TrtC): Geometric mean ratio TrtC: TrtA (%): 115 (90% CI 95 to 138), p = 0.2207, ANOVA
150mg DE (TrtA) vs 150mg DE + 400mg DR Bid Same Time (TrtD): Geometric mean ratio TrtD: TrtA (%): 225 (90% CI 156 to 326), p = 0.9946, ANOVA

Population analysed: PK set.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
150mg DE (TrtA)	0 of 35 (0%)	3 of 35 (8.6%)	Not reported
150mg DE + 400mg DR (TrtB)	0 of 18 (0%)	6 of 18 (33.3%)	Not reported
150mg DE + 400mg DR 2h Later (TrtC)	0 of 17 (0%)	5 of 17 (29.4%)	Not reported
150mg DE + 400mg DR Bid Same Time (TrtD)	0 of 34 (0%)	5 of 34 (14.7%)	Not reported
150mg DE + 400mg DR Bid 2h Later (TrtE)	0 of 30 (0%)	3 of 30 (10%)	Not reported
400mg DR + 400mg DR Bid 2h Later (TrtE2)	0 of 4 (0%)	0 of 4 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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 plus dronedarone and Dabigatran etexilate 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 6 Jun 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 14 Aug 2012). 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 Curve 0 to Infinity (AUC0-∞) (time frame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration). 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 NCT01306162.

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 6 Jun 2014.