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

PLx Pharma

Status and phase: Completed; Phase 1

Conditions: Bioequivalence

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04008979

74,290

Details and patient eligibility

About

Prospective, Randomized, Crossover, Bioequivalence study

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 4 patient groups

PL-ASA 325 mg

Experimental group

Description:

Novel aspirin formulation being tested

Treatment:

Drug: Aspirin

IR 325 mg

Active Comparator group

Description:

Immediate release aspirin

Treatment:

Drug: Aspirin

PL-ASA-650

Experimental group

Description:

Novel aspirin formulation being tested

Treatment:

Drug: Aspirin

IR 650

Active Comparator group

Description:

Immediate release aspirin

Treatment:

Drug: Aspirin