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NCT Number: NCT07801066

Healthy Person Eats, Takes 1 Dose, Tested for Drowsiness, Fall Risk, Then Takes Second Dose Followed by Same Tests

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metaxalone 640 mg

Drug

Dose micronized 640 mg

Other names: m640

Metaxalone 800 MG

Drug

The dose is 800 mg

Other names: Skelaxin

Primary outcomes

  1. 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

    Measures the time between a visual stimulus and response, measured in milliseconds

  2. 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

    measures the time between a visual stimulus and response, measured in milliseconds

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Manager

CONTACT

[email protected]

480-250-6689

Project Manager

CONTACT

[email protected]

480-483-1410

Sponsors and collaborators

Lead sponsor

Primus Pharmaceuticals

Industry

Registry information

Official study title

A Prospective, Randomized, Single-blind, Study to Assess Drowsiness, Cognition, Fall Risk, and Electroencephalographic (EEG) Dynamics After Oral Metaxalone Tablets 640 mg (M640) Versus Metaxalone 800 mg in Healthy Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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