Healthy Participants Will Take One Dose of a Drug After Eating a Meal, Then Test for Drowsiness and Fall Risk With Brain Wave Monitoring Throughout the Testing. Participants Will Take a Second Dose of the Drug With the Same Testing.

Conditions

• Comparison Between 2 Doses of Metaxalone to Measure Drowsiness, Cognition and Fall Risk

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Metaxalone 640 mg — DRUG
  Dose micronized 640 mg
• Metaxalone 800 MG — DRUG
  The dose is 800 mg

Study Details

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.

Key Dates

First listed

Sep 3, 2026

Start date

Sep 15, 2026

Status verified

Aug 2026

Primary completion

Jan 15, 2027

Completion

Jan 15, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Active metaxalone m640 mg
  One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)
• Active Comparator: Active metaxalone 800 mg
  One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)

Primary Outcome Measure

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 ]

Central Contacts

• Project Manager
  480-483-1410
  [email protected]
• Clinical Manager
  480-250-6689
  [email protected]

Locations (1)

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