Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers

PLx Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Upper Gastrointestinal Mucosal Damage

Treatments

Drug: acetylsalicylic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872534

PL-ASA-002

Details and patient eligibility

About

To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.

Enrollment

204 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subject is ≥50 to ≤75 years of age.
Subject is healthy.
Subject has a BMI between 20 and 32
If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Exclusion criteria

Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
Subject has an active Helicobacter pylori infection.
Subject has a prior GI ulcer, bleeding, obstruction or perforation.
Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
Subject has used an investigational agent within the past 30 days.
Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.