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

NCT01379300 | Completed Phase 1

• 1 other identifier: 0000-216
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thrombosis

Keywords

Hemophilia B

Outcome Measures

Primary Outcomes (5)

• Endogenous thrombin potential by Thrombin Generation Assay (TGA)-2a assay

  From up to 2 hours pre-dose to up to 24 hours post-dose

• Level of fibrin degradation product (D-dimer)

  From up to 2 hours pre-dose to up to 24 hours post-dose

• Level of fibrinopeptide A (FPA)

  From up to 2 hours pre-dose to up to 24 hours post-dose

• Level of prothrombin split products (F1+2)

  From up to 2 hours pre-dose to up to 24 hours post-dose

• Level of thrombin-antithrombin complex (TAT)

  From up to 2 hours pre-dose to up to 24 hours post-dose

Study Arms (3)

Dabigatran

EXPERIMENTAL

Single 150-mg dose of dabigatran etexilate

Drug: dabigatran etexilate

Rivaroxaban

EXPERIMENTAL

Single 20-mg dose of rivaroxaban

Drug: rivaroxaban

No intervention

NO INTERVENTION

No study drug will be administered

Interventions

dabigatran etexilate DRUG

dabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration

Dabigatran

rivaroxaban DRUG

rivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration

Rivaroxaban

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Thrombosis; Hemophilia B

Interventions

Dabigatran; Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 23, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 2, 2015

Record last verified: 2015-10