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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02290379

Enrollment

Registered

2014-11-14

Start date

2014-11-30

Completion date

2015-06-30

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

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.

Interventions

DRUGTNX-201 35 mg

Drug: TNX-201 35 mg

DRUGTNX-201 70 mg

Drug: TNX-201 70 mg

DRUGTNX-201 140 mg

Drug: TNX-201 140 mg

DRUGRacemic isometheptene 70 mg

Active Comparator: Racemic isometheptene 70 mg

DRUGPlacebo

Drug: Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026