Trial Outcomes & Findings for Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers. (NCT NCT03168022)

Results Overview

Blood samples were collected prior to drug administration and 0.083 (5 min), 0.167 (10 min),0.333 (20 min), 0.500 (30 min), 0.750 (45 min), 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, and 96.0 hours post-dose in each period.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

0 to 96 hours

Results posted on

2019-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment A First, Then B Single Dose of Treatment A (TNX-102 SL 2.8 mg yellow tablet \[commercial manufacturer\]), Washout 21 days, Single Dose of Treatment B (TNX-102 SL 2.8 mg white tablet \[original manufacturer\])	Treatment B First, Then A Single Dose of Treatment B (TNX-102 SL 2.8 mg white tablet \[original manufacturer\]), Washout 21 days, Single Dose of Treatment A (TNX-102 SL 2.8 mg yellow tablet \[commercial manufacturer\])
Overall Study STARTED	21	22
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=43 Participants All subjects that were randomized to receive all treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 96 hours

Population: Subjects who completed the study and for whom the PK profile could be adequately characterized were included in the outcome measures.

Blood samples were collected prior to drug administration and 0.083 (5 min), 0.167 (10 min),0.333 (20 min), 0.500 (30 min), 0.750 (45 min), 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, and 96.0 hours post-dose in each period.

Outcome measures

Outcome measures
Measure	Treatment A n=42 Participants All study subjects who were administered one TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) under fasting conditions and completed the study.	Treatment B n=42 Participants All study subject who were administered one TNX-102 SL 2.8 mg white tablet (original manufacturer) under fasting conditions and completed the study.
Mean Plasma Concentration (AUC) of Cyclobenzaprine	70066.90 pg*h/mL Standard Deviation 25158.61	64711.53 pg*h/mL Standard Deviation 22633.07

PRIMARY outcome

Timeframe: Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)

Population: All subjects who received at least one dose of either Treatment A or Treatment comprised the safety population (N = 43). Of these, 1 subject discontinued from the study after one dose of Treatment B and was replaced with a stand-by. A total 42 subjects completed the study as per protocol.

The MedDRA® dictionary was used to classify all TEAEs reported during the study by System Organ Class (SOC) and Preferred Term (PT).

Outcome measures

Outcome measures
Measure	Treatment A n=42 Participants All study subjects who were administered one TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) under fasting conditions and completed the study.	Treatment B n=43 Participants All study subject who were administered one TNX-102 SL 2.8 mg white tablet (original manufacturer) under fasting conditions and completed the study.
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Treatment A and Treatment B, Administered as 1 x 2.8 mg TNX-102 SL Under Fasting Conditions.	18 Participants	19 Participants

Adverse Events

Treatment A

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Treatment B

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment A n=42 participants at risk All subjects who were administered TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer).	Treatment B n=43 participants at risk All subjects who were administered TNX-102 SL 2.8 mg white yellow tablet (original manufacturer).
Gastrointestinal disorders Hypoaesthesia oral	31.0% 13/42 • Day 1 up to Day 13.	30.2% 13/43 • Day 1 up to Day 13.
Nervous system disorders Somnolence	11.9% 5/42 • Day 1 up to Day 13.	9.3% 4/43 • Day 1 up to Day 13.
General disorders Product taste abnormal	9.5% 4/42 • Day 1 up to Day 13.	11.6% 5/43 • Day 1 up to Day 13.

Additional Information

Gregory Sullivan, MD

Tonix Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60