Upper Gastrointestinal Mucosal Damage
Conditions
Keywords
To evaluate the acute gastrointestinal safety of PL-2100.
Brief 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.
Interventions
DRUGacetylsalicylic acid
325mg once a day for 7 days
Sponsors
PLx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Subjects With Gastroduodenal Erosions and Ulcers. | After 7 days of study medication | Incidence of subjects with gastroduodenal composite scores of 3 or 4 (\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PL-2200 PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days | 100 |
| Aspirin Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days | 104 |
| Total | 204 |
Baseline characteristics
| Characteristic | PL-2200 | Aspirin | Total |
|---|---|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 6.35 | 56.6 years STANDARD_DEVIATION 6 | 57.3 years STANDARD_DEVIATION 6.2 |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 88 Participants |
| Sex: Female, Male Male | 56 Participants | 60 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 100 | 14 / 104 |
| serious Total, serious adverse events | 0 / 100 | 0 / 104 |
Outcome results
Primary
Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
Incidence of subjects with gastroduodenal composite scores of 3 or 4 (\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).
Time frame: After 7 days of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PL-2200 | Incidence of Subjects With Gastroduodenal Erosions and Ulcers. | Gastroduodenal Composite Score of 3 or 4 (NO) | 72 participants |
| PL-2200 | Incidence of Subjects With Gastroduodenal Erosions and Ulcers. | Gastroduodenal Composite Score of 3 or 4 (YES) | 19 participants |
| Aspirin | Incidence of Subjects With Gastroduodenal Erosions and Ulcers. | Gastroduodenal Composite Score of 3 or 4 (NO) | 54 participants |
| Aspirin | Incidence of Subjects With Gastroduodenal Erosions and Ulcers. | Gastroduodenal Composite Score of 3 or 4 (YES) | 36 participants |