Trial Outcomes & Findings for A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults. (NCT NCT01490788)
NCT ID: NCT01490788
Last Updated: 2019-09-11
Results Overview
Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0 to 96 hours
Results posted on
2019-09-11
Participant Flow
Participant milestones
| Measure |
Treatment A First, Then B, Then C
Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions)
|
Treatment A First, Then C, Then B
Single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions)
|
Treatment B First, Then A, Then C
Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions)
|
Treatment B First, Then C, Then A
Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions)
|
Treatment C First, Then A, Then B
Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions)
|
Treatment C First, Then B, Then A
Single dose of Treatment C (2.4 mg TNX-102 gelcap under fed conditions), Washout (7 days), Single dose of Treatment B (5 mg cyclobenzaprine IR tablet under fasting conditions), Washout (7 days), single dose of Treatment A (2.4 mg TNX-102 gelcap under fasting conditions)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=30 Participants
All subjects that were randomized to receive all three treatments.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 96 hoursBlood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.
Outcome measures
| Measure |
Treatment A
n=30 Participants
All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
|
Treatment B
n=30 Participants
All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
|
Treatment C
n=30 Participants
All study subject who were administered one TNX-102 2.4 mg, gelcap under fed conditions during the course of the study.
|
|---|---|---|---|
|
Mean Plasma Concentration (AUC) of Cyclobenzaprine
|
47,074.19 pg.hr/mL
Interval 30288.11 to 63860.27
|
94,874.26 pg.hr/mL
Interval 60588.45 to 129160.07
|
50,263.16 pg.hr/mL
Interval 30725.75 to 69800.57
|
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)Every adverse events occurring during the study period will be reported.
Outcome measures
| Measure |
Treatment A
n=30 Participants
All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
|
Treatment B
n=30 Participants
All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
|
Treatment C
n=30 Participants
All study subject who were administered one TNX-102 2.4 mg, gelcap under fed conditions during the course of the study.
|
|---|---|---|---|
|
Incidences of Adverse Events
Subjects with Treatment-Emergent Adverse Events
|
14 Participants
|
15 Participants
|
10 Participants
|
|
Incidences of Adverse Events
Subjects with Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidences of Adverse Events
Subjects discontinued due to adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=30 participants at risk
All study subject who were administered one TNX-102 2.4 mg gelcap under fasting conditions during the course of the study.
|
Treatment B
n=30 participants at risk
All study subject who were administered one IR tablet of cyclobenzaprine 5 mg under fasting conditions during the course of the study.
|
Treatment C
n=30 participants at risk
All study subject who were administered one TNX-102 2.4 mg gelcap under fed conditions during the course of the study.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30 • 2 months
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Gastrointestinal disorders
Constipation
|
10.0%
3/30 • 2 months
|
3.3%
1/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Investigations
Blood Pressure increased
|
6.7%
2/30 • 2 months
|
3.3%
1/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Nervous system disorders
Somnolence
|
10.0%
3/30 • 2 months
|
36.7%
11/30 • 2 months
|
6.7%
2/30 • 2 months
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Eye disorders
Photophobia
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
General disorders
Asthenia
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
General disorders
Catheter site erythema
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
General disorders
catheter site pain
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
6.7%
2/30 • 2 months
|
|
General disorders
Vessel puncture site haematoma
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
General disorders
Vessel puncture site reaction
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Injury, poisoning and procedural complications
Laceration
|
3.3%
1/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Injury, poisoning and procedural complications
Sunburn
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Investigations
Heart Rate increased
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Investigations
Mean cell volume increased
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • 2 months
|
3.3%
1/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Psychiatric disorders
Nervousness
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/30 • 2 months
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
|
Vascular disorders
Hot Flush
|
0.00%
0/30 • 2 months
|
3.3%
1/30 • 2 months
|
0.00%
0/30 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60