Trial Outcomes & Findings for A Study of Soticlestat Tablets in Healthy Adults (NCT NCT05284760)
NCT ID: NCT05284760
Last Updated: 2024-02-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
96 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
Part A, Sequence 1: Treatment A + Treatment B + Treatment C
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 2: Treatment A + Treatment C + Treatment B
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 3: Treatment B + Treatment A + Treatment C
Soticlestat T3 mini-tablets 300 milligram (mg), orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 4: Treatment B + Treatment C + Treatment A
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 5: Treatment C + Treatment A + Treatment B
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 6: Treatment C + Treatment B + Treatment A
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T3 mini-tablets 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 1: Treatment D + Treatment E + Treatment F
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 2: Treatment D + Treatment F + Treatment E
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 3: Treatment E + Treatment D + Treatment F
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 4: Treatment E + Treatment F + Treatment D
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 5: Treatment F + Treatment D + Treatment E
Soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 6: Treatment F + Treatment E + Treatment D
Soticlestat T4 300 mg tablets, crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
STARTED
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12
|
12
|
12
|
12
|
12
|
12
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
12
|
12
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Soticlestat Tablets in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part A, Sequence 1: Treatment A + Treatment B + Treatment C
n=12 Participants
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 2: Treatment A + Treatment C + Treatment B
n=12 Participants
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment A, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 3: Treatment B + Treatment A + Treatment C
n=12 Participants
Soticlestat T3 mini-tablets 300 milligram (mg), orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment C. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 4: Treatment B + Treatment C + Treatment A
n=12 Participants
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment B, followed by soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 2 under fasted condition as Treatment C, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 5: Treatment C + Treatment A + Treatment B
n=12 Participants
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment A, and followed by soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment B. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part A, Sequence 6: Treatment C + Treatment B + Treatment A
n=12 Participants
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of Period 1 under fasted condition as Treatment C, followed by soticlestat T3 mini-tablets 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment B, and followed by soticlestat T4 tablets 300 mg, orally, once on Day 1 of Period 3 under fasted condition as Treatment A. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 1: Treatment D + Treatment E + Treatment F
n=4 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 2: Treatment D + Treatment F + Treatment E
n=4 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fasted condition as Treatment D, followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 3: Treatment E + Treatment D + Treatment F
n=4 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 3 under fasted condition as Treatment F. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 4: Treatment E + Treatment F + Treatment D
n=4 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 1 under fed condition as Treatment E, followed by soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 2 under fasted condition as Treatment F, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 5: Treatment F + Treatment D + Treatment E
n=4 Participants
Soticlestat T4 300 mg tablets crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fasted condition as Treatment D, and followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 3 under fed condition as Treatment E. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Part B, Sequence 6: Treatment F + Treatment E + Treatment D
n=4 Participants
Soticlestat T4 300 mg tablets, crushed and mixed with applesauce, orally, once on Day 1 of Period 1 under fasted condition as Treatment F, followed by soticlestat T4 300 mg, tablets, orally, once on Day 1 of Period 2 under fed condition as Treatment E, and followed by soticlestat T4 300 mg tablets, orally, once on Day 1 of Period 3 under fasted condition as Treatment D. A washout interval of exactly 4 days was maintained between each Treatment Period.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
75 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
2 Participants
n=129 Participants
|
21 Participants
n=36 Participants
|
|
Age, Continuous
|
41.1 years
n=93 Participants
|
38.3 years
n=4 Participants
|
43.1 years
n=27 Participants
|
38.3 years
n=483 Participants
|
40.4 years
n=36 Participants
|
40.3 years
n=10 Participants
|
40.0 years
n=115 Participants
|
37.8 years
n=40 Participants
|
49.5 years
n=8 Participants
|
42.3 years
n=62 Participants
|
30.3 years
n=95 Participants
|
38.3 years
n=129 Participants
|
40.1 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
23 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
9 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
73 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
10 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
4 Participants
n=95 Participants
|
4 Participants
n=129 Participants
|
85 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
|
Body Mass Index (BMI)
|
26.626 kilogram per meters squared (kg/m^2)
n=93 Participants
|
27.249 kilogram per meters squared (kg/m^2)
n=4 Participants
|
27.859 kilogram per meters squared (kg/m^2)
n=27 Participants
|
27.943 kilogram per meters squared (kg/m^2)
n=483 Participants
|
26.840 kilogram per meters squared (kg/m^2)
n=36 Participants
|
26.626 kilogram per meters squared (kg/m^2)
n=10 Participants
|
26.843 kilogram per meters squared (kg/m^2)
n=115 Participants
|
26.285 kilogram per meters squared (kg/m^2)
n=40 Participants
|
28.030 kilogram per meters squared (kg/m^2)
n=8 Participants
|
27.120 kilogram per meters squared (kg/m^2)
n=62 Participants
|
26.130 kilogram per meters squared (kg/m^2)
n=95 Participants
|
26.960 kilogram per meters squared (kg/m^2)
n=129 Participants
|
27.286 kilogram per meters squared (kg/m^2)
n=36 Participants
|
|
Height
|
166.8 centimeters (cm)
n=93 Participants
|
169.4 centimeters (cm)
n=4 Participants
|
174.8 centimeters (cm)
n=27 Participants
|
167.5 centimeters (cm)
n=483 Participants
|
171.8 centimeters (cm)
n=36 Participants
|
168.5 centimeters (cm)
n=10 Participants
|
172.3 centimeters (cm)
n=115 Participants
|
171.8 centimeters (cm)
n=40 Participants
|
172.0 centimeters (cm)
n=8 Participants
|
168.0 centimeters (cm)
n=62 Participants
|
172.0 centimeters (cm)
n=95 Participants
|
170.0 centimeters (cm)
n=129 Participants
|
170.1 centimeters (cm)
n=36 Participants
|
|
Weight
|
74.09 kg
n=93 Participants
|
78.38 kg
n=4 Participants
|
85.33 kg
n=27 Participants
|
78.12 kg
n=483 Participants
|
78.83 kg
n=36 Participants
|
79.67 kg
n=10 Participants
|
79.35 kg
n=115 Participants
|
77.33 kg
n=40 Participants
|
82.90 kg
n=8 Participants
|
77.03 kg
n=62 Participants
|
77.78 kg
n=95 Participants
|
78.80 kg
n=129 Participants
|
79.02 kg
n=36 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dosePopulation: All participants who complied sufficiently with the protocol and displayed an evaluable Pharmacokinetic (PK) profile (eg, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK set.
Outcome measures
| Measure |
Part A - Treatment A
n=72 Participants
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment B
n=72 Participants
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment C
n=71 Participants
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment D
n=24 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment E
n=24 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.
|
Part B - Treatment F
n=24 Participants
Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.
|
|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Soticlestat
|
1762 nanogram per milllilitre (ng/ml)
Geometric Coefficient of Variation 66.3
|
1428 nanogram per milllilitre (ng/ml)
Geometric Coefficient of Variation 76.0
|
1708 nanogram per milllilitre (ng/ml)
Geometric Coefficient of Variation 65.1
|
1509 nanogram per milllilitre (ng/ml)
Geometric Coefficient of Variation 65.7
|
565.6 nanogram per milllilitre (ng/ml)
Geometric Coefficient of Variation 49.0
|
1350 nanogram per milllilitre (ng/ml)
Geometric Coefficient of Variation 63.1
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dosePopulation: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile (eg, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK set.
Outcome measures
| Measure |
Part A - Treatment A
n=72 Participants
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment B
n=72 Participants
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment C
n=71 Participants
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment D
n=24 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment E
n=24 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.
|
Part B - Treatment F
n=24 Participants
Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.
|
|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat
|
1649 ng.hour (hr)/ml
Geometric Coefficient of Variation 50.2
|
1433 ng.hour (hr)/ml
Geometric Coefficient of Variation 54.8
|
1606 ng.hour (hr)/ml
Geometric Coefficient of Variation 51.6
|
1503 ng.hour (hr)/ml
Geometric Coefficient of Variation 49.1
|
1317 ng.hour (hr)/ml
Geometric Coefficient of Variation 37.0
|
1435 ng.hour (hr)/ml
Geometric Coefficient of Variation 61.9
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dosePopulation: All participants who complied sufficiently with the protocol and displayed an evaluable PK profile (eg, exposure to treatment, availability of measurements, and absence of major protocol violations) were included in the PK set.
Outcome measures
| Measure |
Part A - Treatment A
n=62 Participants
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment B
n=55 Participants
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment C
n=56 Participants
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment D
n=22 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment E
n=22 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.
|
Part B - Treatment F
n=21 Participants
Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.
|
|---|---|---|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat
|
1659 ng.hr/ml
Geometric Coefficient of Variation 51.0
|
1459 ng.hr/ml
Geometric Coefficient of Variation 58.1
|
1639 ng.hr/ml
Geometric Coefficient of Variation 53.7
|
1525 ng.hr/ml
Geometric Coefficient of Variation 50.6
|
1354 ng.hr/ml
Geometric Coefficient of Variation 35.1
|
1395 ng.hr/ml
Geometric Coefficient of Variation 49.6
|
SECONDARY outcome
Timeframe: From screening up to 14 days after the last dose of soticlestat (Day 51)Population: All participants who received at least one dose of the study drug(s) were included in the safety set.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Part A - Treatment A
n=72 Participants
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment B
n=72 Participants
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A - Treatment C
n=72 Participants
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment D
n=24 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.
|
Part B - Treatment E
n=24 Participants
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.
|
Part B - Treatment F
n=24 Participants
Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
6 Participants
|
12 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Part A: Treatment A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Treatment B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Treatment C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Treatment D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Treatment E
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Treatment F
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Treatment A
n=72 participants at risk
Soticlestat T4 tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A: Treatment B
n=72 participants at risk
Soticlestat T3 mini-tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part A: Treatment C
n=72 participants at risk
Soticlestat T3 commercial tablets 300 mg, orally, once on Day 1 of each period under fasted condition.
|
Part B: Treatment D
n=24 participants at risk
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fasted condition.
|
Part B: Treatment E
n=24 participants at risk
Soticlestat T4 300 mg, tablets, orally, once on Day 1 of each period under fed condition.
|
Part B: Treatment F
n=24 participants at risk
Soticlestat T4 300 mg, tablets crushed and mixed with applesauce, orally, once on Day 1 of each period under fasted condition.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Photophobia
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
3/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
2/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
1.4%
1/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
3/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/72 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.2%
1/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From screening up to 14 days after the last dose of soticlestat (Day 51)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results was made without Sponsor's prior written approval. Any proposed publication or presentation was submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER