Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition
- Registration Number
- NCT06382662
- Lead Sponsor
- Primus Pharmaceuticals
- Brief Summary
Every participant will receive active study drug and one (1 )comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be ( four (4) visits.
- Detailed Description
Every participant will receive active study drug and one (1) comparator in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit.
The Screening Visit will be followed by the Baseline (Visit 1) 1-14 days later. At the Baseline Visit participants will be given written tests to measure thinking process. You will also be asked to take a computer driving simulation test.
Visits 2 and 3 approximately one (1) week apart will be the dosing days after eating a high fat meal within 30 minutes. The testing from the Baseline Visit will be repeated at four (4) hours and 1.5 hours after dosing with comparator drug.
The End of Study safety visit will take place two (2) weeks later. Participants will be given discharge instructions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- equal to or greater than 20 years old
- weight at least 120 pounds
- medically healthy
- able to eat a high fat meal
- medications known to affect sleep-wake cycle
- current use of cimetidine
- current use of certain anti-depressants
- current us of certain antibiotics
- positive urine drug test for mind altering medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description metaxalone m640 mg metaxalone m640 metaxalone micronized 640 mg tablet, single dose at Visit 2 or Visit 3 tizanidine 8 mg tizanidine tizanidine 8 mg tablet, single dose at Visit 2 or Visit 3
- Primary Outcome Measures
Name Time Method Change from baseline, Standard Deviation of Lateral Position Baseline, Visit 2 dosing, (day 1), Visit 3 dosing, (day 8) Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software
Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) Creyos Cognitive Test
- Secondary Outcome Measures
Name Time Method The number of product related adverse events experienced by participants from Visit 1 through Visit 4 Baseline, Visit 2 (Day 0), Visit 3 (Day 1), Visit 4 (Day 8), Visit 4 (Day 15) Adverse and Serious Adverse Events
Change from baseline of participants' subjective report of drowsiness on a 10-point scale Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (Day 8) Karolinska Sleepiness Scale where 1 = extremely alert and 10 = extremely sleepy, can't keep awake
Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test) Visit 2 (Day 0), Visit 3 (Day 1). Visit 4 (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.
Trial Locations
- Locations (1)
Sun Valley Arthritis Center
🇺🇸Peoria, Arizona, United States