Trial Outcomes & Findings for Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet (NCT NCT04690751)
NCT ID: NCT04690751
Last Updated: 2024-08-12
Results Overview
Maximum observed plasma concentration of cenobamate
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
120, 192, 264, 360, 456, hours post-dose
Results posted on
2024-08-12
Participant Flow
Participant milestones
| Measure |
Sequence 1
Treatment ABC, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 2
Treatment BCA, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 3
Treatment CAB, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 4
Treatment ACB, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 5
Treatment BAC, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 6
Treatment CBA, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
5
|
4
|
6
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Treatment ABC, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 2
Treatment BCA, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 3
Treatment CAB, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 4
Treatment ACB, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 5
Treatment BAC, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
Sequence 6
Treatment CBA, with 21 day washout periods between each dose. Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Positive urine drug screen test
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet
Baseline characteristics by cohort
| Measure |
Sequence 1
n=4 Participants
Treatment ABC, with 21 day washout periods between each dose.
Treatment A: cenobamate 200 mg oral tablet fasted Treatment B: cenobamate 200 mg/20 mL oral suspension fasted Treatment C: cenobamate 200 mg/20 mL oral suspension fed
|
Sequence 2
n=5 Participants
Treatment BCA, with 21 day washout periods between each dose.
Treatment A: cenobamate 200 mg oral tablet fasted Treatment B: cenobamate 200 mg/20 mL oral suspension fasted Treatment C: cenobamate 200 mg/20 mL oral suspension fed
|
Sequence 3
n=5 Participants
Treatment CAB, with 21 day washout periods between each dose.
Treatment A: cenobamate 200 mg oral tablet fasted Treatment B: cenobamate 200 mg/20 mL oral suspension fasted Treatment C: cenobamate 200 mg/20 mL oral suspension fed
|
Sequence 4
n=4 Participants
Treatment CBA, with 21 day washout periods between each dose.
Treatment A: cenobamate 200 mg oral tablet fasted Treatment B: cenobamate 200 mg/20 mL oral suspension fasted Treatment C: cenobamate 200 mg/20 mL oral suspension fed
|
Sequence 5
n=6 Participants
Treatment ACB, with 21 day washout periods between each dose.
Treatment A: cenobamate 200 mg oral tablet fasted Treatment B: cenobamate 200 mg/20 mL oral suspension fasted Treatment C: cenobamate 200 mg/20 mL oral suspension fed
|
Sequence 6
n=4 Participants
Treatment BAC, with 21 day washout periods between each dose.
Treatment A: cenobamate 200 mg oral tablet fasted Treatment B: cenobamate 200 mg/20 mL oral suspension fasted Treatment C: cenobamate 200 mg/20 mL oral suspension fed
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 4.32 • n=5 Participants
|
35.6 years
STANDARD_DEVIATION 11.67 • n=7 Participants
|
30.6 years
STANDARD_DEVIATION 12.92 • n=5 Participants
|
29.5 years
STANDARD_DEVIATION 8.74 • n=4 Participants
|
28.5 years
STANDARD_DEVIATION 8.17 • n=21 Participants
|
31.0 years
STANDARD_DEVIATION 5.48 • n=8 Participants
|
30.6 years
STANDARD_DEVIATION 8.83 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
6 participants
n=21 Participants
|
4 participants
n=8 Participants
|
28 participants
n=8 Participants
|
|
Weight
|
74.45 kg
STANDARD_DEVIATION 6.982 • n=5 Participants
|
73.30 kg
STANDARD_DEVIATION 10.458 • n=7 Participants
|
77.52 kg
STANDARD_DEVIATION 9.785 • n=5 Participants
|
83.38 kg
STANDARD_DEVIATION 10.779 • n=4 Participants
|
72.93 kg
STANDARD_DEVIATION 13.896 • n=21 Participants
|
77.93 kg
STANDARD_DEVIATION 13.178 • n=8 Participants
|
76.24 kg
STANDARD_DEVIATION 10.795 • n=8 Participants
|
|
Height
|
174.93 cm
STANDARD_DEVIATION 9.016 • n=5 Participants
|
173.36 cm
STANDARD_DEVIATION 8.993 • n=7 Participants
|
180.72 cm
STANDARD_DEVIATION 5.404 • n=5 Participants
|
182.00 cm
STANDARD_DEVIATION 0.469 • n=4 Participants
|
172.13 cm
STANDARD_DEVIATION 11.965 • n=21 Participants
|
174.60 cm
STANDARD_DEVIATION 13.879 • n=8 Participants
|
176.05 cm
STANDARD_DEVIATION 9.371 • n=8 Participants
|
|
Body Mass Index (BMI)
|
24.30 kg/m2
STANDARD_DEVIATION 1.128 • n=5 Participants
|
24.38 kg/m2
STANDARD_DEVIATION 3.047 • n=7 Participants
|
23.76 kg/m2
STANDARD_DEVIATION 2.919 • n=5 Participants
|
25.15 kg/m2
STANDARD_DEVIATION 3.360 • n=4 Participants
|
24.47 kg/m2
STANDARD_DEVIATION 3.133 • n=21 Participants
|
25.58 kg/m2
STANDARD_DEVIATION 3.336 • n=8 Participants
|
24.56 kg/m2
STANDARD_DEVIATION 2.726 • n=8 Participants
|
PRIMARY outcome
Timeframe: 120, 192, 264, 360, 456, hours post-doseMaximum observed plasma concentration of cenobamate
Outcome measures
| Measure |
Treatment A
n=25 Participants
Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
|
Treatment B
n=24 Participants
Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions
|
Treatment C
n=25 Participants
Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|
|
Cmax
|
4.880 (μg/mL)
Interval 3.77 to 6.66
|
4.680 (μg/mL)
Interval 3.81 to 6.56
|
3.860 (μg/mL)
Interval 3.25 to 4.75
|
PRIMARY outcome
Timeframe: 120, 192, 264, 360, 456 hour post-doseTime to reach Maximum observed plasma concentration of cenobamate
Outcome measures
| Measure |
Treatment A
n=25 Participants
Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
|
Treatment B
n=24 Participants
Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions
|
Treatment C
n=25 Participants
Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|
|
Tmax
|
3.000 (h)
Interval 0.5 to 5.0
|
0.750 (h)
Interval 0.5 to 3.5
|
5.000 (h)
Interval 3.0 to 10.0
|
PRIMARY outcome
Timeframe: 120, 192, 264, 360, 456 hour post-doseAUC from the time of dosing to the time of the last measurable concentration of cenobamate
Outcome measures
| Measure |
Treatment A
n=25 Participants
Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
|
Treatment B
n=24 Participants
Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions
|
Treatment C
n=25 Participants
Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|
|
Area Under the Concentration Curve to Last Measurable Concentration
|
304.0 (μg•h/mL)
Interval 178.0 to 516.0
|
302.5 (μg•h/mL)
Interval 165.0 to 493.0
|
277.0 (μg•h/mL)
Interval 17.0 to 494.0
|
PRIMARY outcome
Timeframe: 120, 192, 264, 360, 456 hour post-doseArea Under the Concentration Curve (AUC) from time 0 extrapolated to infinity
Outcome measures
| Measure |
Treatment A
n=25 Participants
Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
|
Treatment B
n=24 Participants
Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions
|
Treatment C
n=25 Participants
Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|
|
Area Under the Concentration Curve From 0 to Infinity
|
308.0 (μg•h/mL)
Interval 183.0 to 526.0
|
309.5 (μg•h/mL)
Interval 178.0 to 500.0
|
296.0 (μg•h/mL)
Interval 178.0 to 500.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 69To evaluate the safety and tolerability of each cenobamate formulation administered under either fed (Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension ) or fasted (Both tablet and oral suspension formulations) incidence of treatment-emergent adverse events will be monitored.
Outcome measures
| Measure |
Treatment A
n=25 Participants
Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
|
Treatment B
n=24 Participants
Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions
|
Treatment C
n=25 Participants
Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
8 Participants
|
8 Participants
|
7 Participants
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=25 participants at risk
Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
|
Treatment B
n=24 participants at risk
Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions
|
Treatment C
n=25 participants at risk
Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
|
|---|---|---|---|
|
Gastrointestinal disorders
Paraesthesia Oral
|
4.0%
1/25 • Number of events 1 • 69 days
|
0.00%
0/24 • 69 days
|
0.00%
0/25 • 69 days
|
|
General disorders
Catheter Site Related Reaction
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Infections and infestations
Covid-19
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Injury, poisoning and procedural complications
Sunburn
|
4.0%
1/25 • Number of events 1 • 69 days
|
0.00%
0/24 • 69 days
|
0.00%
0/25 • 69 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.0%
1/25 • Number of events 1 • 69 days
|
0.00%
0/24 • 69 days
|
0.00%
0/25 • 69 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • Number of events 3 • 69 days
|
8.3%
2/24 • Number of events 2 • 69 days
|
0.00%
0/25 • 69 days
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • Number of events 1 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/25 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
0.00%
0/25 • 69 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/25 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
0.00%
0/25 • 69 days
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/25 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
0.00%
0/25 • 69 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/25 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
4.0%
1/25 • Number of events 1 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/25 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
0.00%
0/25 • 69 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/25 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
0.00%
0/25 • 69 days
|
|
Skin and subcutaneous tissue disorders
Pruitus
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.00%
0/25 • 69 days
|
4.2%
1/24 • Number of events 1 • 69 days
|
0.00%
0/25 • 69 days
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
4.0%
1/25 • Number of events 1 • 69 days
|
0.00%
0/24 • 69 days
|
0.00%
0/25 • 69 days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/25 • 69 days
|
0.00%
0/24 • 69 days
|
4.0%
1/25 • Number of events 1 • 69 days
|
Additional Information
Executive Director and Head, Clinical Pharmacology
SK Life Science, Inc.
Phone: 862-271-2645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place