Recruiting
Phase 4

Different Formulation

Sponsor:

Primus Pharmaceuticals

Code:

NCT07801066

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Metaxalone 640 mg

Metaxalone 800 MG

Study Details

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.

Conditions

Healthy Participants

Study ID

NCT07801066

Start date

Oct 15, 2026

Status verified date

Sep, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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)

Interventions

Metaxalone 640 mg

Dose micronized 640 mg

Metaxalone 800 MG

The dose is 800 mg

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Project Manager

480-483-1410mshahbandar@primusrx.com

Clinical Manager

480-250-6689msanstead@primusrx.com

Locations

AMR Clinical - Columbus

Recruiting

Columbus, Ohio, United States, 43213

Contacts

Site Manager

614-683-5800jim.sanders@amr-clinical.com

Study Coordinator

614-683-5800kim.burmane@amr-clinical.com

Principal Investigator:

Harold Green, MD

More Information

Sponsor

Primus Pharmaceuticals

Last update posted

Nov 5, 2026

Last verified

Sep, 2026

Keywords

  • Fall Risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Primus Pharmaceuticals on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.