Cognitive Impairment
Conditions
Keywords
Impaired driving
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.
Interventions
DRUGmetaxalone m640 mg
A single dose of micronize metaxalone 640 mg
DRUGtizanidine 8mg
A single dose of tizanidine 8 mg
Sponsors
Primus Pharmaceuticals
Sun Valley Arthritis Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) compared to tizanidine 8 mg in healthy subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* equal to or greater than 18 years old * equal to or less than 65 years old * weight at least 120 pounds * medically healthy * able to eat a high fat meal
Exclusion criteria
* medications known to affect sleep-wake cycle * current use of cimetidine * current use of certain anti-depressants * current use of certain antibiotics * positive urine drug test for mind altering medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline, Standard Deviation of Lateral Position, no Traffic | thirty minutes | Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software |
| Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic | thirty minutes | Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software |
| Change From Baseline, Standard Deviation of Lateral Position, Oncoming Traffic Plus Lead Vehicle | thirty minutes | Using the One Motion GT Elite Mini- Simulator (SimGear) with Carnet Soft Driving Simulation Software |
Countries
United States
Contacts
STUDY_DIRECTORJ C Lukban, DO
Primus Pharmaceuticals
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed