Pharmacokinetic and Pharmacodynamic Assessment of a Novel, Pharmaceutical Lipid-Aspirin Complex

NCT04008979 | Completed Phase 1 FDA Drug

• 1 other identifier: 74,290
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, Randomized, Crossover, Bioequivalence study

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (6)

• Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-T

  Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-T of the metabolite salicylic acid

  twenty four hours

• Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-∞

  Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-∞ of the metabolite salicylic acid

  24 hours

• Bioequivalence of PL-ASA and Immediate Release Aspirin CMAX

  Assess for bioequivalence at 325 mg and 650 mg dose levels CMAX of the metabolite salicylic acid

  24 hours

• Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX

  Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the metabolite salicylic acid

  24 hours

• Bioequivalence of PL-ASA and Immediate Release Aspirin AUC0-24

  Assess for bioequivalence at 325 mg and 650 mg dose levels AUC0-24 of the percent inhibition of serum Thromboxane B2

  24 hours

• Bioequivalence of PL-ASA and Immediate Release Aspirin TMAX STB2

  Assess for bioequivalence at 325 mg and 650 mg dose levels TMAX of the percent inhibition of serum Thromboxane B2

  24 hours

Study Arms (4)

PL-ASA 325 mg

EXPERIMENTAL

Novel aspirin formulation being tested

Drug: Aspirin

IR 325 mg

ACTIVE COMPARATOR

Immediate release aspirin

Drug: Aspirin

PL-ASA-650

EXPERIMENTAL

Novel aspirin formulation being tested

Drug: Aspirin

IR 650

ACTIVE COMPARATOR

Immediate release aspirin

Drug: Aspirin

Interventions

Aspirin DRUG

Aspirin - lipid complex

IR 325 mg; IR 650; PL-ASA 325 mg; PL-ASA-650

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• If female and of childbearing potential, subject has a negative pregnancy test and is not nursing.
• If female and of childbearing potential, subject is using adequate birth control for the duration of the study.
• Subject is able to understand and comply with study procedures.
• Subject is a non-smoker.
• Subject consumes no more than 1 alcoholic drink per day.
• Subject agrees to refrain from alcohol consumption for 48 hours prior to each drug administration and 48 hours after each drug administration.
• Subject is able and willing to provide written informed consent prior to any study procedures being performed.

You may not qualify if:

• Subject has abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator.
• Subject has taken any prescription medications other than hormone replacement therapy or thyroid replacement hormones within 3 days prior to drug administration.
• Subject has taken any of the following medications within 2 weeks prior to study entry:
• NSAIDs or other medications for pain, including aspirin or aspirin containing products and acetaminophen (see Appendix B of protocol in Appendix 16.1.1)
• Proton pump inhibitors, including Prilosec®, Prevacid®, Aciphex®, Protonix®, or Nexium®
• H-2 blockers, including Tagamet®, Zantac®, Axid®, or Pepcid®
• Any antiplatelet agent, including Plavix®, Ticlid®, Pletal®, ReoPro®, Integrilin®, Aggrastat®, or Persantine®
• Any anti-coagulant, including Coumadin®, Acenocoumarol, Phenprocoumon, Phenindione, Heparin, Exanta®, Argatroban, Lepirudin, Hirudin or Bivalirudin
• Subject has used an investigational agent within the past 30 days.
• Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
• Subject has sensitivity to lecithin.
• Subject has a history of gastrointestinal problems including ulcers, frequent indigestion, or heartburn.
• Subject has a history of stroke, myocardial infarction, or congestive heart failure.
• Subject has a history of asthma, other bronchospastic activity, nasal polyps, or angioedema other than resolved childhood asthma.
• Subject has a history of kidney or liver disease.

Sponsors & Collaborators

• PLx Pharma: lead

Related Publications (1)

• Angiolillo DJ, Bhatt DL, Lanza F, Cryer B, Dong JF, Jeske W, Zimmerman RR, von Chong E, Prats J, Deliargyris EN, Marathi U. Pharmacokinetic/pharmacodynamic assessment of a novel, pharmaceutical lipid-aspirin complex: results of a randomized, crossover, bioequivalence study. J Thromb Thrombolysis. 2019 Nov;48(4):554-562. doi: 10.1007/s11239-019-01933-7.

  PMID: 31420787 DERIVED

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Upendra Marathi, PhD

  PLx Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 32 subjects to be randomized to treatment with either immediate release aspirin or PL-ASA at one of two doses (325 mg or 650 mg) administered orally. After completion of the first treatment and a minimum of a two week washout period(14-17 days) subjects are to cross over and receive treatment with the alternative compound at the same dose level.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: February 11, 2008
• Primary Completion: June 10, 2008
• Study Completion: June 10, 2008
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share