Healthy ParticipantsPhase 4NCT07801066
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
A Phase 4 study testing Metaxalone 640 mg and Metaxalone 800 MG in people with Healthy Participants, run by Primus Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Metaxalone 640 mg and Metaxalone 800 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 15 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 55 years old
- Weigh at least 120 pounds
- Medically healthy
- Able to sign and date informed consent form
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AMR Clinical - Columbus
Columbus, Ohio, 43213
Site Manager, 614-683-5800, jim.sanders@amr-clinical.com
Study Coordinator, 614-683-5800, kim.burmane@amr-clinical.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Metaxalone 640 mg, Metaxalone 800 MG
- Keywords
- Fall Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metaxalone 640 mgDrug
Also called m640
Dose micronized 640 mg
Metaxalone 800 MGDrug
Also called Skelaxin
The dose is 800 mg
| Study group | Role | What they receive |
|---|---|---|
| Active metaxalone m640 mg | Active comparator | One dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax) Receives: 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) Receives: Drug: Metaxalone 800 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline dose to approximately 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 Oct 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Lukban, D.O., Study director, Primus Pharmaceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801066
- Sponsor's protocol ID
- PMMD-02
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for publication at this time.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07801066
- Acronym / sponsor ID
- PMMD-02
- Conditions
- Healthy Participants
- Keywords
- Fall Risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active metaxalone m640 mg | Active comparator | Drug: Metaxalone 640 mgOne dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax) |
| Active metaxalone 800 mg | Active comparator | Drug: Metaxalone 800 MGOne dose administered after a standard meal with testing Baseline dose to time of maximum concentration (Tmax) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 18 to 55 years old
- Weigh at least 120 pounds
- Medically healthy
- Able to sign and date informed consent form
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metaxalone 640 mgAlso: m640Dose micronized 640 mg | Drug | Active metaxalone m640 mg |
| Metaxalone 800 MGAlso: SkelaxinThe dose is 800 mg | Drug | Active metaxalone 800 mg |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. No plan for publication at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Lukban, D.O. study director
Primus Pharmaceutical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metaxalone 640 mg and Metaxalone 800 MG in people with Healthy Participants, run by Primus Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (480-483-1410, mshahbandar@primusrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.