HealthyPhase 1NCT02596100
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
A Phase 1 study testing Betrixaban in people with Healthy, run by Portola Pharmaceuticals.
Trial summary
This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Betrixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents.
- A healthy man or woman between the ages of 18 and 60
- Has no clinically significant findings in medical history, physical examination, EKG and vital signs
- Weighs > 45 kg (99 lbs.) and has body mass index (BMI) < 30 kg/m2
- Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods
- Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods
Who cannot join
- None of the exclusion criteria may be present for enrollment
- Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation
- Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug
- History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug
- History of alcohol abuse (greater than 3 alcoholic beverages per day)
- Positive screen for drugs of abuse
- Positive serology test for HIV, Hepatitis B or C
- Has any allergy or sensitivity to fXa inhibitors
About this study
This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.
Read the detailed description
Serial blood samples will be obtained for PK evaluation.
- Conditions
- Healthy
- Being tested
- Betrixaban
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetrixabanDrug
| Study group | Role | What they receive |
|---|---|---|
| Tablet | Experimental | 80mg immediate release tablet Receives: Drug: Betrixaban |
| Capsule | Experimental | 80mg immediate release capsule Receives: Drug: Betrixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects
Measured: 120 hours
Bioequivalance analysis using peak concentration in plasma (Cmax) after a single dose of Betrixaban in healthy volunteers
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portola Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596100
- Sponsor's protocol ID
- 15-020
- Status last verified
- Aug 2023
- First submitted
- 21 Oct 2015
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
- ClinicalTrials.gov ID
- NCT02596100
- Acronym / sponsor ID
- 15-020
- Conditions
- Healthy
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Portola PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Nov 2015 (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.
This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.
Detailed description
Serial blood samples will be obtained for PK evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet | Experimental | Drug: Betrixaban80mg immediate release tablet |
| Capsule | Experimental | Drug: Betrixaban80mg immediate release capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents.
- A healthy man or woman between the ages of 18 and 60
- Has no clinically significant findings in medical history, physical examination, EKG and vital signs
- Weighs > 45 kg (99 lbs.) and has body mass index (BMI) < 30 kg/m2
- Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods
Key exclusion criteria (8 listed)
- None of the exclusion criteria may be present for enrollment
- Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation
- Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug
- History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug
- History of alcohol abuse (greater than 3 alcoholic beverages per day)
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 |
|---|---|---|
| Betrixaban | Drug | Capsule, Tablet |
Primary outcome
Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects
Time frame: 120 hours
Bioequivalance analysis using peak concentration in plasma (Cmax) after a single dose of Betrixaban in healthy volunteers
Time frame: 120 hours
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 8 Aug 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Betrixaban in people with Healthy, run by Portola Pharmaceuticals.
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 6 inclusion and 8 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects (time frame: 120 hours). The study lists 2 primary outcomes in all. 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 8 Aug 2023.