Pharmacodynamic and Pharmacokinetic Study of PL-ASA

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PL-ASA

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PL-ASA capsule, then EC-ASA tablet; PL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg	Drug: PL-ASA; Pharmacologic profile of different aspirin formulations; Other Names: Enteric-coated Aspirin (EC-ASA)
Active Comparator: EC-ASA tablet, then PL-ASA capsule; EC-ASA tablet 81 mg, then crossover to PL-ASA capsule 81 mg	Drug: PL-ASA; Pharmacologic profile of different aspirin formulations; Other Names: Enteric-coated Aspirin (EC-ASA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetylsalicylic acid and salicylic acid	Presence of serum acetylsalicylic acid and salicylic acid	24 hours after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Light transmittance aggregometry	Effects on platelet function by light transmittance aggregometry	24 hours after dosing

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum thromboxane B2	ncidence of aspirin responsiveness among study participants, measured by Inhibition of serum thromboxane B2 and thromboxane B2 levels	24 hours after dosing
Adverse effects	Safety, as indicated by any adverse effects	24 hours after dosing

Collaborators and Investigators

• Sponsor: PLx Pharma

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: PL-ASA-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No