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

NCT ID: NCT01379300

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dabigatran

Single 150-mg dose of dabigatran etexilate

Group Type: EXPERIMENTAL

dabigatran etexilate

Intervention Type: DRUG

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

Rivaroxaban

Single 20-mg dose of rivaroxaban

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

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

No intervention

No study drug will be administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dabigatran etexilate

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

Intervention Type: DRUG

rivaroxaban

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0000-216

Identifier Type: -

Identifier Source: org_study_id