Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT03509883
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-04-18
• Study Start: 2018-04-26
• Study First Posted: 2018-04-26
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Results First Submitted: 2019-06-14
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-13
• Last Update Submitted: 2020-01-13
• Results First Posted: 2020-01-23
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time	Day 1 to Day 8	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time
Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)	Day 1 to Day 8	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration
AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration	Day 1 to Day 8	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time

Secondary Outcome Measures

Name	Time	Method
Physical Measurement - Weight	Pre-treatment screening to Day 8	Average weight of all participants treated
T-Half - Terminal Plasma Half Life.	Day 1 to Day 8	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of time required to reach to half of plasma concentration
Physical Measurement - Height	Pre-treatment Screening	Average height of all participants treated
Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation	Day 1 to Day 38	Adverse events regardless of causality, Serious Adverse Events \& Adverse events leading to discontinuation
Tmax - Time of Maximum Observed Plasma Concentration	Day 1 to Day 8	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration
Frel - Relative Bioavailability	Day 1 to Day 8	The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation
Physical Measurement - Body Mass Index (BMI)	Pre-treatment Screening to Day 8	Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/\[height(m)\]2.
Number of Participants With a Given Clinical Laboratory Abnormality	Day 1 to Day 8	Assessment of clinical laboratory abnormalities
Number of Participants With Out-of Range Vital Signs: Blood Pressure	Day 1 to Day 8	Number of participants with Out-of Range Blood Pressure changes as follows: Systolic Blood Pressure (SBP) mmHg \< 90 and change from baseline \< -20 \> 140 and change from baseline \> 20; Diastolic Blood Pressure (DBP) mmHg \< 55 and change from baseline \< -10 \> 90 and change from baseline \> 10
Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)	Day 1 to Day 8	Number of participants with Out-of Range Heart Rate changes as follows: \< 55 and change from baseline \< -16 \>100 and change from baseline \> 10
Number of Participants With Out-of Range Vital Signs: Respiration Rate	Day 1 to Day 8	Number of participants with Out-of Range respiration rate changes as follows: Respiration Rate is measured by number of respiration per min (rpm) \> 16 rpm Change from baseline \>10 rpm \> 16 rpm or change from baseline \> 10 rpm
Number of Participants With Out-of Range Vital Signs: Temperature	Day 1 to Day 8	Number of participants with Out-of Range temperature changes as follows: Temperature is measured in Degrees centigrade (°C); \>38.3°C Change from baseline \> 1.6°C \>38.3°C or change from baseline \> 1.6°C
Number of Participants With Out-of Range ECG Evaluations	Day 1 to Day 8	Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States