Healthy Participants
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMetaxalone m640 mg oral tablet
Metaxalone partially micronized 640 mg tablet
DRUGMetaxalone 800 mg oral tablet
Metaxalone non-micronized 800 mg oral tablet
Sponsors
ClinOhio Research Services, LLC
Primus Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Single mask of participants. Participants will be prevented from knowing product dose.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Weigh at least 120 pounds at Screening * Medically healthy with no clinically significant medical co-morbidities impact endpoints
Exclusion criteria
* Current use of any medications known to affect sleep-wake cycle. * Known sleep disorder. * Current use of cimetidine. * Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol). * Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids. * Participants taking skeletal muscle relaxants or sedative hypnotics. * Participants with gastrointestinal disease affecting absorption. * Participants with severe hepatic or renal impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test). | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) | 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. |
| Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) | Timed Up and Go with Triaxial Accelerometry |
| Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) | Tandem Walk Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of participants' subjective report of drowsiness on a 10-point scale | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) | Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake |
| The number of product related adverse events experienced by participants from Visit 2 through Visit 4 | Visit 2 dosing (Day 1, Visit 3 dosing (Day 8), Visit 4 End of Study (Day 15) | Adverse and Serious Adverse Events |
| Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) | Reaction Time Test (RTT) |
| Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes | Baseline, Visit 2 dosing (Day 1), Visit 3 dosing (Day 8) | Creyos Cognitive Test |
Countries
United States
Outcome results
None listed