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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PLx Pharma
• Treatments: Aspirin

Criteria

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.