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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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TNX-201 35 mg

Drug: TNX-201 35 mg

Group Type EXPERIMENTAL

TNX-201 35 mg

Intervention Type DRUG

Drug: TNX-201 35 mg

TNX-201 70 mg

Drug: TNX-201 70 mg

Group Type EXPERIMENTAL

TNX-201 70 mg

Intervention Type DRUG

Drug: TNX-201 70 mg

TNX-201 140 mg

Drug: TNX-201 140 mg

Group Type EXPERIMENTAL

TNX-201 140 mg

Intervention Type DRUG

Drug: TNX-201 140 mg

Racemic isometheptene 70 mg

Comparator: Racemic Isometheptene 70 mg

Group Type ACTIVE_COMPARATOR

Racemic isometheptene 70 mg

Intervention Type DRUG

Active Comparator: Racemic isometheptene 70 mg

Placebo

Drug: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Drug: Placebo

Interventions

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TNX-201 35 mg

Drug: TNX-201 35 mg

Intervention Type DRUG

TNX-201 70 mg

Drug: TNX-201 70 mg

Intervention Type DRUG

TNX-201 140 mg

Drug: TNX-201 140 mg

Intervention Type DRUG

Racemic isometheptene 70 mg

Active Comparator: Racemic isometheptene 70 mg

Intervention Type DRUG

Placebo

Drug: Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Body mass index (BMI) ≥18.5 and ≤33.0
3. Non-tobacco users (no use of tobacco- or nicotine- containing products within 3 months prior to study drug administration)

Exclusion Criteria

1. 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
2. Positive urine drug screen (including alcohol, tetrahydrocannabinol (THC), cocaine, amphetamines, and opiates) or urine cotinine test at Screening or on Day -1
3. Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulations.
4. Positive serum pregnancy test at Screening or Day -1
5. 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
6. Clinically significant ECG abnormalities

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes