Clinical trial NCT03509883: Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules
Official title: A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 to Day 8
measure: AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
timeFrame: Day 1 to Day 8
measure: AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
timeFrame: Day 1 to Day 8
Secondary outcomes:
measure: Tmax - Time of Maximum Observed Plasma Concentration
timeFrame: Day 1 to Day 8
measure: T-Half - Terminal Plasma Half Life.
timeFrame: Day 1 to Day 8
measure: Frel - Relative Bioavailability
timeFrame: Day 1 to Day 8
measure: Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
timeFrame: Day 1 to Day 38
measure: Physical Measurement - Height
timeFrame: Pre-treatment Screening
measure: Physical Measurement - Weight
timeFrame: Pre-treatment screening to Day 8
measure: Physical Measurement - Body Mass Index (BMI)
timeFrame: Pre-treatment Screening to Day 8
measure: Number of Participants With a Given Clinical Laboratory Abnormality
timeFrame: Day 1 to Day 8
measure: Number of Participants With Out-of Range Vital Signs: Blood Pressure
timeFrame: Day 1 to Day 8
measure: Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
timeFrame: Day 1 to Day 8
measure: Number of Participants With Out-of Range Vital Signs: Respiration Rate
timeFrame: Day 1 to Day 8
measure: Number of Participants With Out-of Range Vital Signs: Temperature
timeFrame: Day 1 to Day 8
measure: Number of Participants With Out-of Range ECG Evaluations
timeFrame: Day 1 to Day 8
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
References: