HealthyPhase 1NCT03218241
Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote
A Phase 1 study testing PRT064445 in people with Healthy, run by Portola Pharmaceuticals at 1 site in United States.
Trial summary
This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PRT064445
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or women between the ages of 18 and 50 years old, inclusive
- BMI 19-32 and weighs at least 60kgs
Who cannot join
- History or symptoms of bleeding problems or thrombotic conditions
- Clinically significant medical history
- Major surgery, severe trauma, or bone fracture within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote
This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.
- Conditions
- Healthy
- Being tested
- PRT064445, Placebo
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT064445Biological
Intravenous
PlaceboDrug
Also called Placebo (for PRT064445)
Intravenous to mimic PRT064445
| Study group | Role | What they receive |
|---|---|---|
| PRT0064445 Dose 1 | Experimental | Dose 1 versus Placebo Receives: Biological: PRT064445; Drug: Placebo |
| PRT064445 Dose 2 | Experimental | Dose 2 versus Placebo Receives: Biological: PRT064445; Drug: Placebo |
| PRT064445 Dose 3 | Experimental | Dose 3 versus Placebo Receives: Biological: PRT064445; Drug: Placebo |
| PRT064445 Dose 4 | Experimental | Dose 4 versus Placebo Receives: Biological: PRT064445; Drug: Placebo |
| PRT064445 Dose 5 | Experimental | Dose 5 versus Placebo Receives: Biological: PRT064445; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics assessments
Measured: Up to 28 days
Secondary outcomes (1)
Pharmacokinetics: Plasma levels of PRT064445
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startJun 2012
- Primary completionSep 2012
- Study completionOct 2012
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- NCT03218241
- Sponsor's protocol ID
- 11-501
- Status last verified
- Aug 2023
- First submitted
- 27 Dec 2012
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445, a Factor Xa (fXa) Inhibitor Antidote
- ClinicalTrials.gov ID
- NCT03218241
- Acronym / sponsor ID
- 11-501
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Portola PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Jul 2017 (actual)
- 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, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PRT0064445 Dose 1 | Experimental | Biological: PRT064445, Drug: PlaceboDose 1 versus Placebo |
| PRT064445 Dose 2 | Experimental | Biological: PRT064445, Drug: PlaceboDose 2 versus Placebo |
| PRT064445 Dose 3 | Experimental | Biological: PRT064445, Drug: PlaceboDose 3 versus Placebo |
| PRT064445 Dose 4 | Experimental | Biological: PRT064445, Drug: PlaceboDose 4 versus Placebo |
| PRT064445 Dose 5 | Experimental | Biological: PRT064445, Drug: PlaceboDose 5 versus Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men or women between the ages of 18 and 50 years old, inclusive
- BMI 19-32 and weighs at least 60kgs
Key exclusion criteria (3 listed)
- History or symptoms of bleeding problems or thrombotic conditions
- Clinically significant medical history
- Major surgery, severe trauma, or bone fracture within 3 months
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 |
|---|---|---|
| PRT064445Intravenous | Biological | PRT0064445 Dose 1, PRT064445 Dose 2, PRT064445 Dose 3, PRT064445 Dose 4, PRT064445 Dose 5 |
| PlaceboAlso: Placebo (for PRT064445)Intravenous to mimic PRT064445 | Drug | PRT0064445 Dose 1, PRT064445 Dose 2, PRT064445 Dose 3, PRT064445 Dose 4, PRT064445 Dose 5 |
Primary outcome
Pharmacodynamics assessments
Time frame: Up to 28 days
1 secondary outcome
Pharmacokinetics: Plasma levels of PRT064445
Time frame: Up to 7 days
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 4 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.
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 PRT064445 in people with Healthy, run by Portola Pharmaceuticals 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 2 inclusion and 3 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 4 Aug 2023. 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?
Pharmacodynamics assessments (time frame: Up to 28 days). 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 4 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.