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Trial record 6 of 6 for:    "Hemophilia" | "HIV Protease Inhibitors"

A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)

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ClinicalTrials.gov Identifier: NCT01379300
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Thrombosis Drug: dabigatran etexilate Drug: rivaroxaban Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Experimental: Dabigatran
Single 150-mg dose of dabigatran etexilate
Drug: dabigatran etexilate
dabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration

Experimental: Rivaroxaban
Single 20-mg dose of rivaroxaban
Drug: rivaroxaban
rivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration

No Intervention: No intervention
No study drug will be administered



Primary Outcome Measures :
  1. 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 ]
  2. Level of fibrin degradation product (D-dimer) [ Time Frame: From up to 2 hours pre-dose to up to 24 hours post-dose ]
  3. Level of fibrinopeptide A (FPA) [ Time Frame: From up to 2 hours pre-dose to up to 24 hours post-dose ]
  4. Level of prothrombin split products (F1+2) [ Time Frame: From up to 2 hours pre-dose to up to 24 hours post-dose ]
  5. Level of thrombin-antithrombin complex (TAT) [ Time Frame: From up to 2 hours pre-dose to up to 24 hours post-dose ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for non-hemophilia participants:

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
  • 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

Exclusion criteria for non-hemophilia participants:

  • 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
  • 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

Inclusion criteria for hemophilia participants:

  • 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

Exclusion criteria for hemophilia participants:

  • 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

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01379300     History of Changes
Other Study ID Numbers: 0000-216
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015
Keywords provided by Merck Sharp & Dohme Corp.:
Hemophilia B
Additional relevant MeSH terms:
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Protease Inhibitors
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Dabigatran
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action