HealthyPhase 1NCT02710630

Bioavailability Study of Five Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects

A Phase 1 study testing Dabigatran etexilate tablet E1, Dabigatran etexilate tablet D1 and Dabigatran etexilate tablet C1 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

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 primary objective of this trial is to investigate the relative bioavailability of five different tablet formulations of Dabigatran Etexilate, Formulation A1, Formulation B1, Formulation C1, Formulation D1, and Formulation E1, compared to commercial capsule formulation of Dabigatran Etexilate. Read more about this study

Who is it for?: Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Dabigatran etexilate tablet E1, Dabigatran etexilate tablet D1 and Dabigatran etexilate tablet C1
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteJapan
Study dates: 22 Mar 2016to 10 Jun 2016
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 20 to 35 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate [PR]), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age >=20 and <=35 years old
Body mass index (BMI) >=18.0 and <=25.0 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

Any finding in the medical examination (including BP, Pulse Rate, or ECG) deviating from normal and judged as clinically relevant by the investigator at screening
Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm at screening
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any relevant bleeding history considered by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)

Show all 25Show fewer

Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Any history or evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Any evidence of a concomitant disease considered as clinically relevant by the investigator
Intake of drugs with a long half-life (more than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
Intake of medication, which influences the blood clotting, e.g., acetylsalicylic acid, coumarin etc. within 10 days prior to trial medication
Participation in another trial where an investigational drug has been administered within 4 months or 5 half-lives (whichever is greater) prior to planned administration of trial medication
Planned surgeries within four weeks following the end-of study examination
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking during in-house confinement at the trial site
Alcohol abuse (consumption of more than 30 g per day: e.g., 750 mL of beer, 1.5 gous [equivalent to 270 mL] of Sake)
Drug abuse or positive drug screening
Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
Inability to comply with dietary regimen of trial site
Subject assessed as unsuitable for inclusion by the investigator because of, for instance, being considered not able to understand and comply with study requirements, or having a condition that would not allow safe participation in the study

Trial locations and contacts

1 site in 1 country.

Japan1 site

SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 133-0004

Other trials in Japan

About this study

Official title: Relative Bioavailability of Dabigatran After Single Oral Administration of Five Different Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Six-period, Five-sequence Crossover Study)

The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.

Conditions: Healthy
Being tested: Dabigatran etexilate tablet E1, Dabigatran etexilate tablet D1, Dabigatran etexilate tablet C1, Dabigatran etexilate tablet B1, Dabigatran etexilate tablet A1

What participants receive

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

Dabigatran etexilate tablet E1Drug
Dabigatran etexilate tablet D1Drug
Dabigatran etexilate tablet C1Drug
Dabigatran etexilate tablet B1Drug
Dabigatran etexilate tablet A1Drug
Dabigatran etexilate capsuleDrug

Study groups in NCT02710630
Study group	Role	What they receive
Dabigatran etexilate capsule	Active comparator	Not described Receives: Drug: Dabigatran etexilate capsule
Dabigatran etexilate tablet A1	Experimental	Not described Receives: Drug: Dabigatran etexilate tablet A1
Dabigatran etexilate tablet B1	Experimental	Not described Receives: Drug: Dabigatran etexilate tablet B1
Dabigatran etexilate tablet C1	Experimental	Not described Receives: Drug: Dabigatran etexilate tablet C1
Dabigatran etexilate tablet D1	Experimental	Not described Receives: Drug: Dabigatran etexilate tablet D1
Dabigatran etexilate tablet E1	Experimental	Not described Receives: Drug: Dabigatran etexilate tablet E1

What is being measured

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

AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.
Measured: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Cmax (Maximum Concentration of Free Dabigatran)
This outcome measure presents maximum concentration of analyte in plasma (Cmax).
Measured: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Secondary outcomes (4)

AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).
Measured: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.
Measured: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Cmax (Maximum Plasma Concentration of Total Dabigatran)
This outcome measure presents maximum concentration of analyte in plasma (Cmax).
Measured: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).
Measured: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Timeline

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

22 Mar 201610 Jun 2016

First posted17 Mar 2016 (estimated)
Study start22 Mar 2016
Primary completion11 May 2016
Study completion10 Jun 2016

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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02710630
Sponsor's protocol ID: 1160.246
Status last verified: Oct 2017
First submitted: 14 Mar 2016
Last updated: 6 Nov 2017
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 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Dabigatran After Single Oral Administration of Five Different Tablet Formulations of Dabigatran Etexilate Compared to Commercial Capsule Formulation in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Six-period, Five-sequence Crossover Study)
ClinicalTrials.gov ID: NCT02710630
Acronym / sponsor ID: 1160.246
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 22 Mar 2016 (actual)
Primary completion: 11 May 2016 (actual)
Study completion: 10 Jun 2016 (actual)
First posted: 17 Mar 2016 (estimated)
Results: Posted 29 Sep 2017

Clinical summary

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

The secondary objective is to evaluate and compare several pharmacokinetic parameters between the treatments.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Dabigatran etexilate capsule	Active comparator	Drug: Dabigatran etexilate capsule
Dabigatran etexilate tablet A1	Experimental	Drug: Dabigatran etexilate tablet A1
Dabigatran etexilate tablet B1	Experimental	Drug: Dabigatran etexilate tablet B1
Dabigatran etexilate tablet C1	Experimental	Drug: Dabigatran etexilate tablet C1
Dabigatran etexilate tablet D1	Experimental	Drug: Dabigatran etexilate tablet D1
Dabigatran etexilate tablet E1	Experimental	Drug: Dabigatran etexilate tablet E1

Who may qualify

Ages: 20 to 35 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate [PR]), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age >=20 and <=35 years old
Body mass index (BMI) >=18.0 and <=25.0 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Key exclusion criteria (25 listed)

Any finding in the medical examination (including BP, Pulse Rate, or ECG) deviating from normal and judged as clinically relevant by the investigator at screening
Measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm at screening
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any relevant bleeding history considered by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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 tablet E1	Drug	Dabigatran etexilate tablet E1
Dabigatran etexilate tablet D1	Drug	Dabigatran etexilate tablet D1
Dabigatran etexilate tablet C1	Drug	Dabigatran etexilate tablet C1
Dabigatran etexilate tablet B1	Drug	Dabigatran etexilate tablet B1
Dabigatran etexilate tablet A1	Drug	Dabigatran etexilate tablet A1
Dabigatran etexilate capsule	Drug	Dabigatran etexilate capsule

Primary outcome

AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Time frame: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.
Cmax (Maximum Concentration of Free Dabigatran)
Time frame: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
This outcome measure presents maximum concentration of analyte in plasma (Cmax).

4 secondary outcomes

AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
Time frame: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)
Time frame: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
Cmax (Maximum Plasma Concentration of Total Dabigatran)
Time frame: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.
AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)
Time frame: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.

Results and safety

Results posted to the registry on 29 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ref-A1-B1-C1-D1-E1	7	7
Ref-B1-C1-D1-E1-A1	7	7
Ref-C1-D1-E1-A1-B1	7	7
Ref-D1-E1-A1-B1-C1	7	7
Ref-E1-A1-B1-C1-D1	7	7

Primary outcome: AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)

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

Measure	Dabigatran Etexilate Capsule: Ref n = 35	Dabigatran Etexilate Tablet: A1 n = 34	Dabigatran Etexilate Tablet: B1 n = 35	Dabigatran Etexilate Tablet: C1 n = 35	Dabigatran Etexilate Tablet: D1 n = 35	Dabigatran Etexilate Tablet: E1 n = 35
Value	600 (51.8)	714 (42.1)	318 (327)	354 (96.6)	649 (78.6)	661 (54.8)

Dabigatran Etexilate Tablet: A1: Ratio [Test/Reference]: 119.33 (90% CI 101.838 to 139.834)
Dabigatran Etexilate Tablet: B1: Ratio [Test/Reference]: 52.97 (90% CI 33.341 to 84.158)
Dabigatran Etexilate Tablet: C1: Ratio [Test/Reference]: 59.01 (90% CI 45.255 to 76.955)

Population analysed: The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.

Primary outcome: Cmax (Maximum Concentration of Free Dabigatran)

Measure	Dabigatran Etexilate Capsule: Ref n = 35	Dabigatran Etexilate Tablet: A1 n = 34	Dabigatran Etexilate Tablet: B1 n = 35	Dabigatran Etexilate Tablet: C1 n = 35	Dabigatran Etexilate Tablet: D1 n = 35	Dabigatran Etexilate Tablet: E1 n = 35
Value	73.5 (60.0)	86.8 (39.3)	42.3 (213)	45.5 (81.5)	79.6 (73.5)	79.2 (52.7)

Dabigatran Etexilate Tablet: A1: Ratio [Test/Reference]: 118.31 (90% CI 99.569 to 140.579)
Dabigatran Etexilate Tablet: B1: Ratio [Test/Reference]: 57.49 (90% CI 38.502 to 85.837)
Dabigatran Etexilate Tablet: C1: Ratio [Test/Reference]: 61.94 (90% CI 48.130 to 79.720)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 1 day after last drug administration, up to 81 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate Capsule: Ref	0 of 35 (0%)	0 of 35 (0%)	Not reported
Dabigatran Etexilate Tablet: A1	0 of 34 (0%)	0 of 34 (0%)	Not reported
Dabigatran Etexilate Tablet: B1	0 of 35 (0%)	0 of 35 (0%)	Not reported
Dabigatran Etexilate Tablet: C1	0 of 35 (0%)	0 of 35 (0%)	Not reported
Dabigatran Etexilate Tablet: D1	0 of 35 (0%)	0 of 35 (0%)	Not reported
Dabigatran Etexilate Tablet: E1	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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 tablet E1, Dabigatran etexilate tablet D1 and Dabigatran etexilate tablet C1 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.

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 4 inclusion and 25 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 Nov 2017. 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 Japan. 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 29 Sep 2017). 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?

AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point) (time frame: 1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h 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 NCT02710630.

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 Nov 2017.