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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01689259
Other study ID # TNX-CY-F103
Secondary ID
Status Completed
Phase Phase 1
First received September 14, 2012
Last updated September 24, 2014
Start date September 2012
Est. completion date March 2014

Study information

Verified date September 2014
Source Tonix Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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 TNX-102 2.4 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) at 2.4 mg and 4.8 mg and to compare the bio-availability of TNX-102 2.4 mg SL Tablets at 2.4 mg and 4.8 mg to that of TNX-102-A 2.4 mg SL Tablets (without phosphate) at 2.4 mg and cyclobenzaprine (5 mg tablets).


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy adults

- Male or female

- Non-smoker

- 18-65 years old

- 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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SL TNX-102 at 2.4 mg
1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
SL TNX-102 at 4.8 mg
2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them.
SL TNX-102-A at 2.4 mg
1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
Cyclobenzaprine tablets
1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water

Locations

Country Name City State
Canada PharmaNet, Inc. Quebec City Quebec

Sponsors (1)

Lead Sponsor Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measured levels of cyclobenzaprine and norcyclobenzaprine in plasma and 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, 48, and 72 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, 24-48 and 48-72 hours post-dose. 27 time points per period for blood assessment ; 3 pooled analyses in urine. No
Primary Safety and tolerability of TNX-102 SL Tablets at 2.4 mg and 4.8 mg. Every adverse events occurring during the study period will be reported. Continuously until the end (day 4) of the study period + Telephone follow-up 7-13 days after dosing (total duration: about 1 month) Yes
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