Randomized, Crossover Bioequivalence Study of PL-ASA Versus Immediate Release Aspirin in Healthy Volunteers.

NCT05055752 | Completed Phase 1 FDA Drug

• 1 other identifier: PL-ASA-009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a randomized, actively-controlled, open-label, 2-way crossover bioequivalence study to determine PK parameters following treatment with test aspirin product (PL-ASA capsules) and reference aspirin product (IR-ASA tablets) administered at a single dose of 325 mg.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Bioequivalence of single-dose acetylsalicylic acid PK of the PL-ASA formulation to IR-ASA in healthy volunteers at 325 mg dose level.

  Bioequivalence using serum determinations of acetylsalicylic acid concentration

  24 hours after dosing

Study Arms (2)

PL-ASA capsule, then IR-ASA tablet

OTHER

One PL-ASA 325 mg capsule, 14 day washout then one IR-ASA 325 mg tablet

Drug: Pharmaceutical-lipid aspirin (PL-ASA)

IR-ASA tablet, then PL-ASA capsule

OTHER

One IR-ASA 325 mg tablet, 14 day washout, then one PL-ASA 325 mg capsule,

Drug: Pharmaceutical-lipid aspirin (PL-ASA)

Interventions

Pharmaceutical-lipid aspirin (PL-ASA) DRUG

Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.

Also known as: Immediate-release aspirin (IR-ASA)

IR-ASA tablet, then PL-ASA capsule; PL-ASA capsule, then IR-ASA tablet

Eligibility Criteria

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

You may qualify if:

• Male or female subjects at least 18 years of age without known acute or chronic medical conditions requiring treatment;
• If female, a negative pregnancy test and not nursing;
• If female and of childbearing potential, use of adequate birth control for the duration of the study (i.e., barrier methods such as female diaphragm or male condom; intrauterine devices, hormonal implants, pill, patch, shot, vaginal ring, etc.; total abstinence from heterosexual intercourse when it is in line with the preferred and usual lifestyle of the subject; vasectomized partner);
• Non-smoker, including no use of any smoking cessation nicotine-containing products (i.e., nicotine replacement therapy \[patch, spray, inhaler, gum, lozenge, bupropion SR, clonidine and nortriptyline\], e-cigarettes, etc.) for at least 3 months prior to screening;
• Consumes on average no more than 2 alcoholic drinks (1 drink is defined as approximately 12 oz of regular beer, 5 oz of wine, or 1.5 oz of hard liquor) per day for at least 30 days prior to screening;
• A body mass index (BMI) between 18 to 32 kg/m2;
• Agrees to refrain from alcohol consumption for 48 hours prior to and 48 hours after drug administration; and
• Able and willing to provide written informed consent prior to the study.

You may not qualify if:

• Abnormal screening/baseline laboratory parameters deemed to be clinically significant by the Investigator;
• Positive urine alcohol and drug screen result;
• Use of any prescription medications other than hormone replacement therapy, thyroid replacement therapy, or oral contraceptive within 3 days prior to study drug administration;
• Use of antacid medications, including over-the-counter (OTC) products within 3 days prior to study drug administration;
• Use of dietary or herbal supplements containing salicylates, fish oil, or any vitamins within 2 weeks of study drug administration;
• Use of any of the following medications within 2 weeks prior to study drug administration:
• Non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin or aspirin-containing products and acetaminophen.
• Any anti-platelet agent, including clopidogrel, prasugrel, ticagrelor, ticlopidine, cangrelor, dipyridamole, cilostazol, vorapaxar, abciximab, eptifibatide, tirofiban, or triflusal.
• Any anti-coagulant agent, including warfarin, acenocoumarol, phenprocoumon, phenindione, rivaroxaban, dabigatran, apixaban, edoxaban, heparin, enoxaparin, fondaparinux, ximelagatran, argatroban, lepirudin, hirudin, or bivalirudin.
• Use of an investigational agent within the past 30 days prior to drug administration.
• Hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID;
• Soy allergy or sensitivity;
• History of:
• Gastrointestinal problems including ulcers, frequent indigestion, or frequent heartburn.
• Coronary disease, stroke, or congestive heart failure.

Sponsors & Collaborators

• PLx Pharma: lead

Study Sites (1)

PRA-EDS

Lenexa, Kansas, 66219, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All investigators, Sponsor personnel, clinical monitors, independent PK analyst, and subjects in the study will be unblinded to the treatment allocation as all of the primary and secondary endpoints are based on objective criteria of laboratory findings. Laboratory personnel involved in the analysis will be blinded to the treatment allocation
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, single dose 2-way crossover study in healthy volunteers

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 24, 2021
• Study Start: May 7, 2020
• Primary Completion: June 29, 2020
• Study Completion: October 1, 2020
• Last Updated: April 27, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)