Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

Healthy Volunteers Clinical Trial

Official title:

A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509883
• Other study ID #: CV185-687
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: January 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Drug: Apixaban sprinkle capsules
Single dose (25 x 0.1 mg capsules), oral administration
• Experimental: Apixaban tablets followed by apixaban sprinkle capsules
Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration	Day 1 to Day 8
Primary	AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time	Day 1 to Day 8
Primary	AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time	Day 1 to Day 8
Secondary	Tmax - Time of Maximum Observed Plasma Concentration	Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration	Day 1 to Day 8
Secondary	T-Half - Terminal Plasma Half Life.	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	Day 1 to Day 8
Secondary	Frel - Relative Bioavailability	The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation	Day 1 to Day 8
Secondary	Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation	Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation	Day 1 to Day 38
Secondary	Physical Measurement - Height	Average height of all participants treated	Pre-treatment Screening
Secondary	Physical Measurement - Weight	Average weight of all participants treated	Pre-treatment screening to Day 8
Secondary	Physical Measurement - Body Mass Index (BMI)	Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/[height(m)]2.	Pre-treatment Screening to Day 8
Secondary	Number of Participants With a Given Clinical Laboratory Abnormality	Assessment of clinical laboratory abnormalities	Day 1 to Day 8
Secondary	Number of Participants With Out-of Range Vital Signs: Blood Pressure	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	Day 1 to Day 8
Secondary	Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)	Number of participants with Out-of Range Heart Rate changes as follows: < 55 and change from baseline < -16 >100 and change from baseline > 10	Day 1 to Day 8
Secondary	Number of Participants With Out-of Range Vital Signs: Respiration Rate	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	Day 1 to Day 8
Secondary	Number of Participants With Out-of Range Vital Signs: Temperature	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	Day 1 to Day 8
Secondary	Number of Participants With Out-of Range ECG Evaluations	Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)	Day 1 to Day 8

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