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

NCT07801066 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: PMMD-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Fall Risk

Outcome Measures

Primary Outcomes (2)

• 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)

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

  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)

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

  Baseline dose to approximately 4 hours post-dose

Study Arms (2)

Active metaxalone m640 mg

ACTIVE COMPARATOR

One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)

Drug: Metaxalone 640 mg

Active metaxalone 800 mg

ACTIVE COMPARATOR

One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax)

Drug: Metaxalone 800 MG

Interventions

Metaxalone 640 mg DRUG

Dose micronized 640 mg

Also known as: m640

Active metaxalone m640 mg

Metaxalone 800 MG DRUG

The dose is 800 mg

Also known as: Skelaxin

Active metaxalone 800 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 55 years old
• Weigh at least 120 pounds
• Medically healthy
• Able to sign and date informed consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead

Study Sites (1)

AMR Clinical - Columbus

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Interventions

metaxalone

Study Officials

• James Lukban, D.O.

  Primus Pharmaceutical, Inc.

  STUDY DIRECTOR

Central Study Contacts

Project Manager

CONTACT

480-483-1410; mshahbandar@primusrx.com

Clinical Manager

CONTACT

480-250-6689; msanstead@primusrx.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 3, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)