Healthy VolunteersPhase 4NCT04811625
Pharmacodynamic and Pharmacokinetic Study of PL-ASA
A Phase 4 study testing PL-ASA in people with Healthy Volunteers, run by PLx Pharma at 1 site in United States.
Trial summary
A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PL-ASA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 15 Sep 2021
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female non-smoking subjects between the ages of 18 to 75 years inclusive, without known medical conditions requiring treatment
- Consumes on average no more than 2 alcoholic drinks per day for 30 days prior to study
Who cannot join
- Abnormal baseline laboratory results
- Current prescribed use of aspirin, warfarin or other anticoagulants
- Use of other specific medications within 2 weeks of study start
- History of certain medical conditions
- Subject's platelets are unresponsive to arachidonic acid, as defined as <60% of aggregation as measured by light transmittance aggregometry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida C
Jacksonville, Florida, 32209
About this study
Official title: A Randomized, Open-label, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of a Novel Pharmaceutical Lipid-aspirin Complex Formulation (PL-ASA) at an 81 mg Dose
A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose
Read the detailed description
This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.
- Conditions
- Healthy Volunteers
- Being tested
- PL-ASA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PL-ASADrug
Also called Enteric-coated Aspirin (EC-ASA)
Pharmacologic profile of different aspirin formulations
| Study group | Role | What they receive |
|---|---|---|
| PL-ASA capsule, then EC-ASA tablet | Other | PL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg Receives: Drug: PL-ASA |
| EC-ASA tablet, then PL-ASA capsule | Active comparator | EC-ASA tablet 81 mg, then crossover to PL-ASA capsule 81 mg Receives: Drug: PL-ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetylsalicylic acid and salicylic acid
Presence of serum acetylsalicylic acid and salicylic acid
Measured: 24 hours after dosing
Secondary outcomes (1)
Light transmittance aggregometry
Effects on platelet function by light transmittance aggregometry
Measured: 24 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start28 Apr 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- PLx Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Franchi, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811625
- Sponsor's protocol ID
- PL-ASA-010
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franchi F, Schneider DJ, Prats J, Fan W, Rollini F, Been L, Taatjes-Sommer HS, Bhatt DL, Deliargyris EN, Angiolillo DJ. Pharmacokinetic and pharmacodynamic profiles of a novel phospholipid-aspirin complex liquid formulation and low dose enteric-coated aspirin: results from a prospective, randomized, crossover study. J Thromb Thrombolysis. 2022 Oct;54(3):373-381. doi: 10.1007/s11239-022-02687-5. Epub 2022 Aug 29.
PubMed 36036856
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of a Novel Pharmaceutical Lipid-aspirin Complex Formulation (PL-ASA) at an 81 mg Dose
- ClinicalTrials.gov ID
- NCT04811625
- Acronym / sponsor ID
- PL-ASA-010
- Conditions
- Healthy Volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PLx PharmaIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 23 Mar 2021 (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.
A randomized, open-label, 2-way crossover pharmacodynamic and pharmacokinetic study of a novel pharmaceutical lipid-aspirin complex formulation (PL-ASA) at an 81 mg dose
Detailed description
This study is a randomized, open-label, 2-way crossover study to assess pharmacodyamic and pharmacokinetic profiles following treatment with PL-ASA and EC-ASA administered under fasting condition at a single dose of 81 mg among the volunteers aged 50 to 75 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PL-ASA capsule, then EC-ASA tablet | Other | Drug: PL-ASAPL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg |
| EC-ASA tablet, then PL-ASA capsule | Active comparator | Drug: PL-ASAEC-ASA tablet 81 mg, then crossover to PL-ASA capsule 81 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female non-smoking subjects between the ages of 18 to 75 years inclusive, without known medical conditions requiring treatment
- Consumes on average no more than 2 alcoholic drinks per day for 30 days prior to study
Key exclusion criteria (5 listed)
- Abnormal baseline laboratory results
- Current prescribed use of aspirin, warfarin or other anticoagulants
- Use of other specific medications within 2 weeks of study start
- History of certain medical conditions
- Subject's platelets are unresponsive to arachidonic acid, as defined as <60% of aggregation as measured by light transmittance aggregometry
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 |
|---|---|---|
| PL-ASAAlso: Enteric-coated Aspirin (EC-ASA)Pharmacologic profile of different aspirin formulations | Drug | EC-ASA tablet, then PL-ASA capsule, PL-ASA capsule, then EC-ASA tablet |
Primary outcome
Acetylsalicylic acid and salicylic acid
Time frame: 24 hours after dosing
Presence of serum acetylsalicylic acid and salicylic acid
1 secondary outcome
Light transmittance aggregometry
Time frame: 24 hours after dosing
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 25 Apr 2022.
- Derived from this study: PubMed 36036856Franchi F, Schneider DJ, Prats J, Fan W, Rollini F, Been L, Taatjes-Sommer HS, Bhatt DL, Deliargyris EN, Angiolillo DJ. Pharmacokinetic and pharmacodynamic profiles of a novel phospholipid-aspirin complex liquid formulation and low dose enteric-coated aspirin: results from a prospective, randomized, crossover study. J Thromb Thrombolysis. 2022 Oct;54(3):373-381. doi: 10.1007/s11239-022-02687-5. Epub 2022 Aug 29.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Francesco Franchi, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PL-ASA in people with Healthy Volunteers, run by PLx Pharma 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 5 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 25 Apr 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Acetylsalicylic acid and salicylic acid (time frame: 24 hours after dosing). 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 NCT04811625, which also lists 1 linked publication.
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 25 Apr 2022.