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NCT Number: NCT04811625

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida C

Jacksonville, Florida, 32209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PL-ASA

Drug

Pharmacologic profile of different aspirin formulations

Other names: Enteric-coated Aspirin (EC-ASA)

Primary outcomes

  1. Acetylsalicylic acid and salicylic acid

    Time frame: 24 hours after dosing

    Presence of serum acetylsalicylic acid and salicylic acid

Secondary outcomes

  1. Light transmittance aggregometry

    Time frame: 24 hours after dosing

    Effects on platelet function by light transmittance aggregometry

Other outcomes

  1. Serum thromboxane B2

    Time frame: 24 hours after dosing

    ncidence of aspirin responsiveness among study participants, measured by Inhibition of serum thromboxane B2 and thromboxane B2 levels

  2. Adverse effects

    Time frame: 24 hours after dosing

    Safety, as indicated by any adverse effects

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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