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.
1 other identifier
interventional
27
0 countries
N/A
Brief Summary
Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Nov 2014
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 6, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMay 17, 2016
November 1, 2014
6 months
November 6, 2014
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (5)
TNX-201 35 mg
EXPERIMENTALDrug: TNX-201 35 mg
TNX-201 70 mg
EXPERIMENTALDrug: TNX-201 70 mg
TNX-201 140 mg
EXPERIMENTALDrug: TNX-201 140 mg
Racemic isometheptene 70 mg
ACTIVE COMPARATORComparator: Racemic Isometheptene 70 mg
Placebo
PLACEBO COMPARATORDrug: Placebo
Interventions
Active Comparator: Racemic isometheptene 70 mg
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2014
First Posted
November 14, 2014
Study Start
November 1, 2014
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
May 17, 2016
Record last verified: 2014-11