Pharmacodynamic and Pharmacokinetic Study of PL-ASA

NCT04811625 | Completed Phase 4 FDA Drug

• 1 other identifier: PL-ASA-010
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Acetylsalicylic acid and salicylic acid

  Presence of serum acetylsalicylic acid and salicylic acid

  24 hours after dosing

Secondary Outcomes (1)

• Light transmittance aggregometry

  24 hours after dosing

Other Outcomes (2)

• Serum thromboxane B2

  24 hours after dosing

• Adverse effects

  24 hours after dosing

Study Arms (2)

PL-ASA capsule, then EC-ASA tablet

OTHER

PL-ASA capsule 81 mg, then crossover to EC-ASA tablet 81 mg

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

Drug: PL-ASA

Interventions

PL-ASA DRUG

Pharmacologic profile of different aspirin formulations

Also known as: Enteric-coated Aspirin (EC-ASA)

EC-ASA tablet, then PL-ASA capsule; PL-ASA capsule, then EC-ASA tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PLx Pharma: lead

Study Sites (1)

University of Florida C

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• 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.

  PMID: 36036856 DERIVED

Study Officials

• Francesco Franchi, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: April 28, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)