Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.
Interventions
DRUGNaproxen
Single orally administered dose of 500 mg naproxen
DRUGPL 3100
Single orally administered dose of PL 3100 (500 mg naproxen)
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
PLx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-75 years, inclusive. * Subject has a Body Mass Index (BMI) between 20 and 32, inclusive. * Normal physical examination as determined by the Investigator. * Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit. * If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing. * If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study.
Exclusion criteria
* Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol. * Subject has had an acute illness within 5 days of study medication administration. * Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study. * Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Plasma Naproxen From 0 to t | 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration. | Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants who were enrolled in the study. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 12.43 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Area Under the Curve of Plasma Naproxen From 0 to t
Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration.
Time frame: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.
Population: Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PL 3100 | Area Under the Curve of Plasma Naproxen From 0 to t | 67763.0 min×μg/mL |
| Naproxen | Area Under the Curve of Plasma Naproxen From 0 to t | 69427.9 min×μg/mL |