Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg

Primus Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Healthy Participants

Treatments: Drug: Metaxalone m640 mg oral tablet; Drug: Metaxalone 800 mg oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06348303

PMMD-01

Details and patient eligibility

About

Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks.

Full description

The Screening-Baseline Visit will include vital signs and urine testing, and a discussion of medications and current medical history. Participants will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk.

Visit 2 approximately one to two (1 to 2) week(s) later will be the first dosing day (Arm 1) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.

Visit 3 approximately one (1) week later will be the second dosing day (Arm 2) after eating the high fat meal. The testing from Baseline will be repeated four (4) hours after the medication dose is taken.

The End of Study safety visit will take place one (1) week after Visit 3 by phone with a discussion of any side effects from the drug, recent medications, and any illness or injury experienced since the previous visit. Participants will be given end of study and discharge instructions.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Weigh at least 120 pounds at Screening
• Medically healthy with no clinically significant medical co-morbidities impact endpoints

Exclusion criteria

• Current use of any medications known to affect sleep-wake cycle.
• Known sleep disorder.
• Current use of cimetidine.
• Current use of a monoamine oxidase Inhibitor (MAOI), selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), 5- hydroxytryptamine (5-HT) agonist or any drug that has the potential to affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, tramadol).
• Positive urine test for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, or cannabinoids.
• Participants taking skeletal muscle relaxants or sedative hypnotics.
• Participants with gastrointestinal disease affecting absorption.
• Participants with severe hepatic or renal impairment.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Active 640 mg

Active Comparator group

Description:

Metaxalone (M640) 640 mg tablet, a single-dose at visit 2 of 4 visits.

Treatment:

Drug: Metaxalone m640 mg oral tablet

Active 800 mg

Active Comparator group

Description:

Metaxalone 800 mg tablet, a single-dose at Visit 3 of 4 visits.

Treatment:

Drug: Metaxalone 800 mg oral tablet