ThrombosisPhase 1NCT01379300
A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)
A Phase 1 study testing dabigatran etexilate and rivaroxaban in people with Thrombosis, run by Merck Sharp & Dohme LLC.
Trial summary
This is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- dabigatran etexilate and rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Panel A
- Male or female between 65 to 85 years of age
- Panel B
- Male between 18 to 45 years of age
- Both Panels
- Weight of ≥50 kg and ≤110 kg
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- In good health
- No clinically significant abnormality on electrocardiogram (ECG)
- Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
- Male with diagnosis of hemophilia B between 18 to 64 years of age
- Weight of ≥110 lbs and ≤300 lbs
- Has not received clotting factor in the 7 days prior to blood sampling
- No active bleeding event
- No procedure or surgery in the past 8 weeks
- Judged to be in good health based on medical history
- Has not smoked more than 2 cigarettes per day for at least approximately 1 week prior; has not smoked a pipe or cigar or chewed tobacco for at least 3 days prior
- Can refrain from the use of all NSAIDs (e.g., Advil, Aleve, aspirin), all NSAID-containing products (including pain, cold, and allergy products, etc.), herbal meds or drugs for 7 days prior to the date of study procedure
Who cannot join
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal (including peptic ulcer disease), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of malignant neoplastic disease, with the exception of adequately treated non-melanomatous skin carcinoma or other malignancies that have been successfully treated ≥10 years prior to the study
- History of a thrombotic or platelet-related disorder including prior deep venous thrombosis or pulmonary embolus
- Use of warfarin, coumadin, heparin, aspirin, dabigatran etexilate, rivaroxaban or dipyridamole within 2 weeks
- History of poor wound healing
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- Unable to refrain from or anticipates the use of any medication, including aspirin and aspirin-containing products, all non-steroidal anti-inflammatory drug (NSAID)-containing products (including pain, cold and allergy products, etc.) and including prescription and non-prescription drugs or herbal remedies (such as St. John's Wort [Hypericum perforatum]) beginning approximately 2 weeks (or 5 half-lives) prior to initiation of the treatment periods, throughout the study until the post-study visit
- Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
- Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
- Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) or participation in another investigational study within 4 weeks
- History of significant multiple and/or severe allergies (including latex allergy), or an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food, including dabigatran etexilate and rivaroxaban
- Current regular user (including illicit drugs or has a history of drug [including alcohol] abuse within approximately 6 months
- History (including family history if hereditary) or symptoms of clinically relevant bleeding disorder
- Organic lesion at risk of bleeding (e.g., aneurysm, cavernous hemangioma, arterio-venous malformation)
- History of frequent epistaxis or has recurrent or active gingivitis or hemorrhoids
- Clinically significant endocrine, gastrointestinal (including peptic ulcer disease), cardiovascular, hematological (except factor IX deficiency), immunological, renal, respiratory, neurological or genitourinary abnormalities or diseases
- History of malignant neoplastic disease, with the exception of adequately treated non-melanomatous skin carcinoma or other malignancies that have been successfully treated ≥10 years prior to the study
- Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) within 24 hours prior to study procedures
- Major surgery, donation or loss of 1 unit of blood (approximately 500 mL) or participation in another investigational study within 7 days prior to the date of study procedures
- Current regular user (including illicit drugs or has a history of drug [including alcohol] abuse within approximately 6 months
About this study
Official title: A Randomized Clinical Trial to Validate Novel Biomarker Approaches After Single Doses of Anticoagulants in Healthy Young Male Subjects and in Healthy Elderly Subjects
This is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects.
- Conditions
- Thrombosis
- Being tested
- dabigatran etexilate, rivaroxaban
- Keywords
- Hemophilia B
- Medical subject headings
- Thrombosis, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dabigatran etexilateDrug
dabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration
rivaroxabanDrug
rivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran | Experimental | Single 150-mg dose of dabigatran etexilate Receives: Drug: dabigatran etexilate |
| Rivaroxaban | Experimental | Single 20-mg dose of rivaroxaban Receives: Drug: rivaroxaban |
| No intervention | No intervention | No study drug will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous thrombin potential by Thrombin Generation Assay (TGA)-2a assay
Measured: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of fibrin degradation product (D-dimer)
Measured: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of fibrinopeptide A (FPA)
Measured: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of prothrombin split products (F1+2)
Measured: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of thrombin-antithrombin complex (TAT)
Measured: From up to 2 hours pre-dose to up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379300
- Sponsor's protocol ID
- 0000-216
- Status last verified
- Oct 2015
- First submitted
- 3 Jun 2011
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Validate Novel Biomarker Approaches After Single Doses of Anticoagulants in Healthy Young Male Subjects and in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT01379300
- Acronym / sponsor ID
- 0000-216
- Conditions
- Thrombosis
- Keywords
- Hemophilia B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to investigate biomarkers after single oral doses of the anticoagulant agents dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dabigatran | Experimental | Drug: dabigatran etexilateSingle 150-mg dose of dabigatran etexilate |
| Rivaroxaban | Experimental | Drug: rivaroxabanSingle 20-mg dose of rivaroxaban |
| No intervention | No intervention | –No study drug will be administered |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Panel A
- Male or female between 65 to 85 years of age
- Panel B
- Male between 18 to 45 years of age
- Both Panels
Key exclusion criteria (20 listed)
- History of stroke, chronic seizures, or major neurological disorder
- History of clinically significant endocrine, gastrointestinal (including peptic ulcer disease), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of malignant neoplastic disease, with the exception of adequately treated non-melanomatous skin carcinoma or other malignancies that have been successfully treated ≥10 years prior to the study
- History of a thrombotic or platelet-related disorder including prior deep venous thrombosis or pulmonary embolus
- Use of warfarin, coumadin, heparin, aspirin, dabigatran etexilate, rivaroxaban or dipyridamole within 2 weeks
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 etexilatedabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration | Drug | Dabigatran |
| rivaroxabanrivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration | Drug | Rivaroxaban |
Primary outcome
Endogenous thrombin potential by Thrombin Generation Assay (TGA)-2a assay
Time frame: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of fibrin degradation product (D-dimer)
Time frame: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of fibrinopeptide A (FPA)
Time frame: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of prothrombin split products (F1+2)
Time frame: From up to 2 hours pre-dose to up to 24 hours post-dose
Level of thrombin-antithrombin complex (TAT)
Time frame: From up to 2 hours pre-dose to up to 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dabigatran etexilate and rivaroxaban in people with Thrombosis, run by Merck Sharp & Dohme LLC.
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 17 inclusion and 20 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 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endogenous thrombin potential by Thrombin Generation Assay (TGA)-2a assay (time frame: From up to 2 hours pre-dose to up to 24 hours post-dose). The study lists 5 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 2 Oct 2015.