Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy Volunteers

Study Overview
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Brief Summary
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Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers.

Detailed Description
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Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers. Three successive cohorts are planned with doses of TNX-201 capsules, 35 mg, 70 mg, and 140 mg, respectively. Each cohort will consist of 15 subjects, and subjects will be randomly assigned to TNX-201, racemic isometheptene, or placebo capsules.

Official Title
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A Single-Center, Randomized, Double-blind, Placebo-controlled, Phase 1, Single Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of TNX-201 Capsules in Healthy Volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: TNX-201 35 mg
* Drug: TNX-201 70 mg
* Drug: TNX-201 140 mg
* Drug: Racemic isometheptene 70 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ≥ 18 and ≤ 55 years of age on the day of randomization. NOTE: At least 6 female subjects need to be randomized in each cohort. Body mass index (BMI) ≥18.5 and ≤33.0 Non-tobacco users (no use of tobacco- or nicotine- containing products within 3 months prior to study drug administration) Exclusion Criteria: Any clinically significant abnormality or clinically significant abnormal laboratory test results found at Screening or Day -1, or a positive test for HBsAg, HCAb, or HIV found at Screening Positive urine drug screen (including alcohol, tetrahydrocannabinol (THC), cocaine, amphetamines, and opiates) or urine cotinine test at Screening or on Day -1 Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulations. Positive serum pregnancy test at Screening or Day -1 Any reason, in the opinion of the Principal Investigator (PI) or the sponsor's Medical Monitor, to prevent the subject from participating in the study Clinically significant ECG abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNX-201 35 mg<br>Drug: TNX-201 35 mg | Drug: TNX-201 35 mg<br>* Drug: TNX-201 35 mg<br>|
| Experimental: TNX-201 70 mg<br>Drug: TNX-201 70 mg | Drug: TNX-201 70 mg<br>* Drug: TNX-201 70 mg<br>|
| Experimental: TNX-201 140 mg<br>Drug: TNX-201 140 mg | Drug: TNX-201 140 mg<br>* Drug: TNX-201 140 mg<br>|
| Active Comparator: Racemic isometheptene 70 mg<br>Comparator: Racemic Isometheptene 70 mg | Drug: Racemic isometheptene 70 mg<br>* Active Comparator: Racemic isometheptene 70 mg<br>|
| Placebo Comparator: Placebo<br>Drug: Placebo | Drug: Placebo<br>* Drug: Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of isometheptene or metabolites. |  | 60 minutes pre-dose and multiple timepoints up to 48 hours post-dose | 
| Number of Adverse events |  | 60 minutes pre-dose and multiple timepoints up to 48 hours post-dose |