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| Name | Class |
|---|---|
| ClinOhio Research Services, LLC | INDUSTRY |
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Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.
The Screening-Baseline Visit will include vital signs and urine testing, and a discussion of medications and current medical history. Participants will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk.
Visit 2 approximately one to two (1 to 2) week(s) later will be the first dosing day (Arm 1) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
Visit 3 approximately one (1) week later will be the second dosing day (Arm 2) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.
The End of Study safety visit will take place one (1) week after Visit 3 by phone with a discussion of any side effects from the drug, recent medications, and any illness or injury experienced since the previous visit. Participants will be given end of study and discharge instructions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active 640 mg | Active Comparator | Metaxalone (M640) 640 mg tablet, a single-dose at visit 2 of 4 visits. |
|
| Active 800 mg | Active Comparator | Metaxalone 800 mg tablet, a single-dose at Visit 3 of 4 visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metaxalone m640 mg oral tablet | Drug | Metaxalone partially micronized 640 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test). | Validated 4-Stage Balance Test after completion of an FDA standardized high-fat meal. Place one foot in front of the other, heel touching toes. | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) |
| Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path | Timed Up and Go with Triaxial Accelerometry | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) |
| Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path | Tandem Walk Test | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of participants' subjective report of drowsiness on a 10-point scale | Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) |
| Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Lukban, DO | Primus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClinOhio Research Institute | Columbus | Ohio | 43213 | United States |
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| ID | Term |
|---|---|
| C011301 | metaxalone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing.
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Single mask of participants. Participants will be prevented from knowing product dose.
| Metaxalone 800 mg oral tablet | Drug | Metaxalone non-micronized 800 mg oral tablet |
|
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Reaction Time Test (RTT) |
| Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) |
| Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes | Creyos Cognitive Test | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) |
| The number of product related adverse events experienced by participants from Visit 2 through Visit 4 | Adverse and Serious Adverse Events | Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15) |