A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics Following Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants: A Bootstrap Validation.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Primus Pharmaceuticals
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT)
Study Overview
Brief Summary
Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.
Detailed Description
Healthy participants will take one dose of a drug after eating a meal. When the drug is at the highest level in their blood, testing for drowsiness and the risk of falling will take place. Brain wave monitoring known as an EEG will take place throughout the testing. Participants will take a second dose of the drug with the same testing one week later.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy adults aged 18 to 55 years old
- •Weigh at least 120 pounds
- •Medically healthy
- •Able to sign and date informed consent form
Exclusion Criteria
- •Current use of any medications known to affect the sleep-wake cycle
- •Sleep disorder diagnosis
- •Positive urine test for drugs
- •Known history of alcohol use disorder
- •Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia
- •Having difficulty eating high fat meal
- •Participants who are pregnant, nursing or intending to become pregnant during the period of study.
- •Blood Pressure > 160/110 or <90/50 mmHg.
- •Heart Rate >100 or < 50/ beats per minute.
- •Having a history of seizure disorder or epilepsy.
Arms & Interventions
Active metaxalone m640 mg
One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)
Intervention: Metaxalone 640 mg (Drug)
Active metaxalone 800 mg
One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)
Intervention: Metaxalone 800 MG (Drug)
Outcomes
Primary Outcomes
Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT)
Time Frame: Baseline dose to four (4 ) hours post-dose
Change from baseline to approximately 4 hours post-dose of delayed response exceeding a predefined threshold >300 ms as measured by the Reaction Time Test (RTT)
Time Frame: Baseline dose to approximately 4 hours post-dose
Secondary Outcomes
No secondary outcomes reported