Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules; Drug: Drug: Apixaban sprinkle capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT03509883

CV185-687

Details and patient eligibility

About

The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single oral dose of apixaban twice during the course of the study.

Enrollment: 94 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Signed informed consent form.
• Healthy male and female participants determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs (electrocardiograms), vital signs and clinical laboratory determinations.
• Women of childbearing potential (WOCBP) must have negative serum pregnancy tests (performed at screening and Day 1), must not be breastfeeding, and must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 33 days after last dose of apixaban.
• Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 93 days after the last dose of apixaban; and must be willing to refrain from sperm donation during this time.
• Body mass index (BMI) of 18.0 to 30.0 kg/m², inclusive. Body mass index = weight (kg)/[height(m)]².

Exclusion criteria

• History of chronic headaches (occurring 15 days or more a month) over the previous 3 months.
• History of gastroesophageal reflux disease, dyspepsia, protracted nausea, or chronic diarrhea.
• History or evidence of abnormal bleeding or coagulation disorders, hypermenorrhea, intracranial hemorrhage, or abnormal bleeding or coagulation disorders.
• Inability to comply with restrictions and prohibited treatments (e.g. women currently taking hormonal contraception).
• Use of tobacco- or nicotine-containing products (e.g. cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, nicotine gum) within 6 months prior to study drug administration.
• Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Apixaban sprinkle capsules followed by apixaban tablets

Experimental group

Description:

Apixaban (BMS-562247) sprinkle capsules followed by apixaban tablets

Treatment:

Drug: Drug: Apixaban sprinkle capsules

Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules

Apixaban tablets followed by apixaban sprinkle capsules

Active Comparator group

Description:

Apixaban (BMS-562247) tablets followed by apixaban sprinkle capsules

Treatment:

Drug: Drug: Apixaban sprinkle capsules

Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules