Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIH Grant 1R44AR056529-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL 3100 | Experimental | Active experimental drug |
|
| Naproxen | Active Comparator | Active comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Single orally administered dose of 500 mg naproxen |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Upendra K. Marathi, PhD | PLx Pharma Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Institute for Clinical Research | Houston | Texas | 77074 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PL3100 First, Then Naproxen | First Intervention Period: PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen) (after 7-14 day washout period) Second Intervention Period: Naproxen: Single orally administered dose of 500 mg naproxen |
| FG001 | Naproxen First, Then PL3100 | First Intervention Period: Naproxen: Single orally administered dose of 500 mg naproxen (after 7-14 day washout period) Second Intervention Period: PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants who were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Pharmacokinetic (PK) Evaluable Population consists of the 28 subjects who completed the study with no protocol deviations. | Posted | Mean | Full Range | min×μg/mL | 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. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PL 3100 | Active experimental drug PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Partial Thromboplastin Time | Blood and lymphatic system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Zimmerman | PLx Pharma | 1-713-842-1249 | 205 | ron.zimmerman@plxpharma.com |
Not provided
| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PL 3100 |
| Drug |
Single orally administered dose of PL 3100 (500 mg naproxen) |
|
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | Naproxen | Active comparator Naproxen: Single orally administered dose of 500 mg naproxen | 0 | 34 | 0 | 34 |
Standard Confidentiality Agreement
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |