Healthy Participants
Conditions
Keywords
Fall Risk
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.
Interventions
DRUGMetaxalone 640 mg
Dose micronized 640 mg
The dose is 800 mg
Sponsors
Primus Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline dose to four (4 ) hours post-dose | Measures the time between a visual stimulus and response, measured in milliseconds |
| 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) | Baseline dose to approximately 4 hours post-dose | measures the time between a visual stimulus and response, measured in milliseconds |
Countries
United States
Contacts
CONTACTProject Manager
CONTACTClinical Manager
STUDY_DIRECTORJames Lukban, D.O.
Primus Pharmaceutical, Inc.
Outcome results
None listed