- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889173
Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults
September 24, 2014 updated by: Tonix Pharmaceuticals, Inc.
A Single-Dose, Open-Label, Randomized, Parallel-Design Study Of The Comparative Pharmacokinetics And Safety Of TNX-102 2.8 mg SL Tablets (With Potassium Phosphate) At 2.8 mg, TNX-102-B 2.8 mg SL Tablets (With Sodium Phosphate) At 2.8 mg, TNX-102-C 2.8 mg SL Tablets (With Trisodium Citrate) At 2.8 mg, And Cyclobenzaprine 5 mg Oral Tablets In Healthy Adults
Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use.
The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Quebec City, Quebec, Canada, G1P 0A2
- PharmaNet, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults
- Male or female
- 18-65 years old
- Non-smoker
- BMI > 18.5 and < 30.0
- With medically acceptable form of contraception (female only)
- With signed informed consent
Exclusion Criteria:
- Any clinically significant abnormality including ECG abnormalities or vital sign abnormalities (systolic blood pressure < 90 or > 140 mmHg,
- Diastolic blood pressure lower < 50 or > 90 mmHg, or heart rate < 50 or > 100 BPM)
- Any abnormal laboratory test (including positivity for Hep B, Hep C, HIV, and
- Hemoglobin < 128 g/L (males) or < 115 g/L (females) and hematocrit < 0.37 L/L (males) or < 0.32 L/L (females))
- History of alcohol or drug abuse or dependence within 1 year and/or positive drug, cotinine, or alcohol tests
- Use of any drug (within 30 days), supplement, or food (within 14 days) known to induce or inhibit hepatic drug metabolism prior to study medication
- Positive pregnancy test, breastfeeding or lactating
- Use of medication other than hormonal contraceptives or topical products, including OTC, natural health products, MAO inhibitors
- Participation in an investigational study within 30 days prior to dosing
- Donation of plasma (within 7 days), or donation or loss of blood of 50-499 mL (within 30 days), or of > 499 mL (within 56 days) prior to dosing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine oral tablet
|
1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
|
Experimental: TNX-102 SL Tablets at 2.8 mg
1 x TNX-102 SL Tablets (with potassium phosphate) at 2.8 mg
|
1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.
|
Experimental: TNX-102-B SL Tablets at 2.8 mg
1 x TNX-102-B SL Tablets (with sodium phosphate) at 2.8 mg
|
1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.
|
Experimental: TNX-102-C SL Tablets at 2.8 mg
1 x TNX-102-C SL Tablets (with trisodium citrate) at 2.8 mg
|
1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and urine
Time Frame: 26 time points per period for blood assessment ; 2 pooled analyses in urine.
|
Blood samples will be taken per period: within 30 minutes pre-dose and 2, 3.5, 5, 10, 20, 30, and 45 minutes and 1, 2, 2.5, 3, 3.33, 3.67, 4, 4.33, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, and 48 hours post-dose.
A single urine sample will be collected within 30 minutes pre-dose (one sample), and urine will be pooled from 0-24 and 24-48 hours post-dose.
|
26 time points per period for blood assessment ; 2 pooled analyses in urine.
|
Safety and tolerability of the 3 formulations of TNX-102 SL Tablets at 2.8 mg
Time Frame: Continuously until the end (day 3) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month)
|
Every adverse events occurring during the study period will be reported.
|
Continuously until the end (day 3) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Seth M. Lederman, MD, Tonix Pharmaceuticals, Inc.
- Study Director: Jeffrey P. Kitrelle, MD, Tonix Pharmaceuticals, Inc.
- Principal Investigator: Denis Audet, MD, PharmaNet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
June 25, 2013
First Submitted That Met QC Criteria
June 25, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Estimate)
September 26, 2014
Last Update Submitted That Met QC Criteria
September 24, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TNX-CY-F104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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