N/A - Healthy SubjectsPhase 1NCT02262533
Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
A Phase 1 study testing Apixaban and Atenolol in people with N/A - Healthy Subjects, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- N/A - Healthy Subjects
- What is being tested?
- Apixaban and Atenolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations
Who cannot join
- Any significant acute or chronic medical illness, history of hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Bms Clinical Research Center
Hamilton, New Jersey, 08690
About this study
Official title: Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.
- Conditions
- N/A - Healthy Subjects
- Being tested
- Apixaban, Atenolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
AtenololDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Apixaban | Experimental | Apixaban tablet by mouth on specified day Receives: Drug: Apixaban |
| Treatment B: Atenolol | Experimental | Atenolol tablet by mouth on specified day Receives: Drug: Atenolol |
| Treatment C: Apixaban and Atenolol | Experimental | Apixaban and Atenolol tablets by mouth on specified day Receives: Drug: Apixaban; Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apixaban and Atenolol plasma concentration
Blood samples for Atenolol PK were collected on days 1-3 of each period (Treatment B and C). Blood samples for Apixaban PK were collected on days 1-4 of each period (Treatment A and C)
Measured: Days 1-13
Secondary outcomes (1)
Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests
Measured: Days 1-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJun 2007
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for N/A - Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262533
- Sponsor's protocol ID
- CV185-033
- Status last verified
- Aug 2015
- First submitted
- 9 Oct 2014
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02262533
- Acronym / sponsor ID
- CV185-033
- Conditions
- N/A - Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jun 2007
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Apixaban | Experimental | Drug: ApixabanApixaban tablet by mouth on specified day |
| Treatment B: Atenolol | Experimental | Drug: AtenololAtenolol tablet by mouth on specified day |
| Treatment C: Apixaban and Atenolol | Experimental | Drug: Apixaban, Drug: AtenololApixaban and Atenolol tablets by mouth on specified day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations
Key exclusion criteria (1 listed)
- Any significant acute or chronic medical illness, history of hypotension, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years
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 |
|---|---|---|
| Apixaban | Drug | Treatment A: Apixaban, Treatment C: Apixaban and Atenolol |
| Atenolol | Drug | Treatment B: Atenolol, Treatment C: Apixaban and Atenolol |
Primary outcome
Apixaban and Atenolol plasma concentration
Time frame: Days 1-13
Blood samples for Atenolol PK were collected on days 1-3 of each period (Treatment B and C). Blood samples for Apixaban PK were collected on days 1-4 of each period (Treatment A and C)
1 secondary outcome
Safety and Tolerability based on adverse events (AE) reports and the results of vital sign measurements, electrocardiogram (ECGs), physical examinations, and clinical laboratory tests
Time frame: Days 1-13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apixaban and Atenolol in people with N/A - Healthy Subjects, run by Bristol-Myers Squibb at 1 site in United States.
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 1 inclusion and 1 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 10 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Apixaban and Atenolol plasma concentration (time frame: Days 1-13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2015.