Pharmacodynamic and Pharmacokinetic Study of PL-ASA

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811625
• Other study ID #: PL-ASA-010
• Status: Completed
• Phase: Phase 4
• Start date: April 28, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: April 2022
• Source: PLx Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PL-ASA
Pharmacologic profile of different aspirin formulations

Locations

Country	Name	City	State
United States	University of Florida C	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
PLx Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Adverse effects	Safety, as indicated by any adverse effects	24 hours after dosing
Primary	Acetylsalicylic acid and salicylic acid	Presence of serum acetylsalicylic acid and salicylic acid	24 hours after dosing
Secondary	Light transmittance aggregometry	Effects on platelet function by light transmittance aggregometry	24 hours after dosing