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

NCT ID: NCT04008979

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-11
• Study Completion Date: 2008-06-10

Brief Summary

Prospective, Randomized, Crossover, Bioequivalence study

Detailed Description

Active-control crossover study randomizing 32 healthy volunteers to receive one of two dose levels, 325 mg or 650 mg, of either PL-ASA or immediate release aspirin within a two week washout period between treatments. The primary objectives are to assess PK and PD bioequivalence and safety over a twenty four hour period for PL-ASA and immediate release aspirin at 325 mg and 650 mg dose strengths.

Conditions

Bioequivalence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PL-ASA 325 mg

Novel aspirin formulation being tested

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Aspirin - lipid complex

IR 325 mg

Immediate release aspirin

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Aspirin - lipid complex

PL-ASA-650

Novel aspirin formulation being tested

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

Aspirin - lipid complex

IR 650

Immediate release aspirin

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Aspirin - lipid complex

Interventions

Aspirin

Aspirin - lipid complex

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Subject has a history of thrombocytopenia, neutropenia, or bleeding disorder.
• Subject has a history of coronary arterial bypass.
• Subject has a history of non-trauma related hemorrhage.
• Subject has a history of chronic hypertension.
• Subject is currently enrolled in another investigational trial.
• Subject's platelets are unresponsive to arachidonic acid

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PLx Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Upendra Marathi, PhD

Role: STUDY_DIRECTOR

PLx Pharma

References

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.

Reference Type: DERIVED

PMID: 31420787 (View on PubMed)

Other Identifiers

74,290

Identifier Type: -

Identifier Source: org_study_id