Healthy VolunteersPhase 1NCT03509883

Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

A Phase 1 study testing Drug: Apixaban sprinkle capsules and Experimental: Apixaban tablets followed by apixaban sprinkle capsules in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Drug: Apixaban sprinkle capsules and Experimental: Apixaban tablets followed by apixaban sprinkle capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteUnited States
Study dates: 26 Apr 2018to 15 Jun 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

PPD Development, LP
Austin, Texas, 78744

Other trials in United States

About this study

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

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.

Conditions: Healthy Volunteers
Being tested: Drug: Apixaban sprinkle capsules, Experimental: Apixaban tablets followed by apixaban sprinkle capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug: Apixaban sprinkle capsulesDrug
Also called •BMS-562247, •Eliquis
Single dose (25 x 0.1 mg capsules), oral administration
Experimental: Apixaban tablets followed by apixaban sprinkle capsulesDrug
Also called •BMS-562247
Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration

Study groups in NCT03509883
Study group	Role	What they receive
Apixaban sprinkle capsules followed by apixaban tablets	Experimental	Apixaban (BMS-562247) sprinkle capsules followed by apixaban tablets Receives: Drug: Drug: Apixaban sprinkle capsules; Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules
Apixaban tablets followed by apixaban sprinkle capsules	Active comparator	Apixaban (BMS-562247) tablets followed by apixaban sprinkle capsules Receives: Drug: Drug: Apixaban sprinkle capsules; Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 8

Secondary outcomes (13)

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
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 8
Frel - Relative Bioavailability
The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 38
Physical Measurement - Height
Average height of all participants treated
Measured: Pre-treatment Screening
Physical Measurement - Weight
Average weight of all participants treated
Measured: Pre-treatment screening to Day 8
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.
Measured: Pre-treatment Screening to Day 8
Number of Participants With a Given Clinical Laboratory Abnormality
Assessment of clinical laboratory abnormalities
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 8
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
Measured: Day 1 to Day 8
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)
Measured: Day 1 to Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 201815 Jun 2018

First posted26 Apr 2018
Study start26 Apr 2018
Primary completion15 Jun 2018
Study completion15 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03509883
Sponsor's protocol ID: CV185-687
Status last verified: Jan 2020
First submitted: 18 Apr 2018
Last updated: 23 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Absorption of Apixaban (BMS-562247) Sprinkle Capsules Compared With Tablets in Healthy Volunteers
ClinicalTrials.gov ID: NCT03509883
Acronym / sponsor ID: CV185-687
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 26 Apr 2018 (actual)
Primary completion: 15 Jun 2018 (actual)
Study completion: 15 Jun 2018 (actual)
First posted: 26 Apr 2018 (actual)
Results: Posted 23 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Apixaban sprinkle capsules followed by apixaban tablets	Experimental	Drug: Drug: Apixaban sprinkle capsules, Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsulesApixaban (BMS-562247) sprinkle capsules followed by apixaban tablets
Apixaban tablets followed by apixaban sprinkle capsules	Active comparator	Drug: Drug: Apixaban sprinkle capsules, Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsulesApixaban (BMS-562247) tablets followed by apixaban sprinkle capsules

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drug: Apixaban sprinkle capsulesAlso: •BMS-562247, •EliquisSingle dose (25 x 0.1 mg capsules), oral administration	Drug	Apixaban sprinkle capsules followed by apixaban tablets, Apixaban tablets followed by apixaban sprinkle capsules
Experimental: Apixaban tablets followed by apixaban sprinkle capsulesAlso: •BMS-562247Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration	Drug	Apixaban sprinkle capsules followed by apixaban tablets, Apixaban tablets followed by apixaban sprinkle capsules

Primary outcome

Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
Time frame: 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
Time frame: 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
AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
Time frame: 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

13 secondary outcomes

Tmax - Time of Maximum Observed Plasma Concentration
Time frame: Day 1 to Day 8
T-Half - Terminal Plasma Half Life.
Time frame: Day 1 to Day 8
Frel - Relative Bioavailability
Time frame: Day 1 to Day 8
Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation
Time frame: Day 1 to Day 38
Physical Measurement - Height
Time frame: Pre-treatment Screening
Physical Measurement - Weight
Time frame: Pre-treatment screening to Day 8
Physical Measurement - Body Mass Index (BMI)
Time frame: Pre-treatment Screening to Day 8
Number of Participants With a Given Clinical Laboratory Abnormality
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Blood Pressure
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Respiration Rate
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range Vital Signs: Temperature
Time frame: Day 1 to Day 8
Number of Participants With Out-of Range ECG Evaluations
Time frame: Day 1 to Day 8

Results and safety

Results posted to the registry on 23 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A, Then Treatment B	15	15
Treatment B, Then Treatment A	15	15

Primary outcome: Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1 to Day 8. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A n = 30	Treatment B n = 30
Value	77.4 (26.5)	99.3 (24.6)

Population analysed: All Treated Participants

Primary outcome: AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration

Time frame: Day 1 to Day 8. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment A n = 30	Treatment B n = 30
Value	695.9 (27.3)	769.2 (23.7)

Population analysed: All Treated Participants

Primary outcome: AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time

Time frame: Day 1 to Day 8. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment A n = 30	Treatment B n = 30
Value	714.7 (26.9)	787.9 (23.1)

Population analysed: All Treated Participants

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 40 days (1st dose to 30 days after study completion). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30
Treatment B	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration as Measured by Maximum Observed Plasma Concentration (Cmax) (time frame: Day 1 to Day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03509883.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020; AzTrials last refreshed its copy on 31 Oct 2026.