Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B). Participants in part A will receive 300 mg of soticlestat administered in different kind of tablets (regular tablets, mini-tablets, commercial tablets) and participant in part B will also receive 300 mg of soticlestat in tablets but with food and crushed tablets with applesauce. Participants will complete several assessments including clinical laboratory evaluations, physical examinations, Columbia-Suicide Severity Rating Scale (C-SSRS) assessment, electrocardiographs (ECGs), and vital signs.
Detailed description
The drug being tested in this study is called soticlestat (TAK-935). The study will assess the bioequivalence, effect of food and tablet crushing, safety and tolerability following single oral dose of 3 different soticlestat oral tablet formulations in healthy participants. The study will enroll approximately 96 participants. This study will be conducted in two parts (Part A and Part B) having 6 treatment sequences each. Participants will be randomly assigned (by chance, like flipping a coin) to one of the study parts as per treatment sequence: * Part A, Sequence 1: Treatment A + Treatment B + Treatment C * Part A, Sequence 2: Treatment A + Treatment C + Treatment B * Part A, Sequence 3: Treatment B + Treatment A + Treatment C * Part A, Sequence 4: Treatment B + Treatment C + Treatment A * Part A, Sequence 5: Treatment C + Treatment A + Treatment B * Part A, Sequence 6: Treatment C + Treatment B + Treatment A * Part B, Sequence 1: Treatment D + Treatment E + Treatment F * Part B, Sequence 2: Treatment D + Treatment F + Treatment E * Part B, Sequence 3: Treatment E + Treatment D + Treatment F * Part B, Sequence 4: Treatment E + Treatment F + Treatment D * Part B, Sequence 5: Treatment F + Treatment D + Treatment E * Part B, Sequence 6: Treatment F + Treatment E + Treatment D This single center trial will be conducted in the United States. The overall duration of the study is approximately 51 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment.
Interventions
DRUGSoticlestat
Soticlestat T4 tablets.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at screening. 2. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing. 3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the Investigator or designee. 4. Able to swallow multiple tablets. Key
Exclusion criteria
1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing. 2. Positive urine drug or alcohol results at screening or check-in. 3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). 4. Unable to refrain from or anticipates the use of: * Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to the first dosing. * Any drugs known to be significant inducers of cytochrome P450 (CYP) 3A, CYP2C19, uridine 5'-diphospho-glucuronosyltransferase (UGT) 1A9 or UGT2B4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing. Appropriate sources will be consulted to confirm lack of PK/pharmacodynamics interaction with study drug. 5. History of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer \[354 milliliter per 12 ounce {mL/12 oz}\], wine \[118 mL/4 oz\], or distilled spirits \[29.5 mL/1 oz\] per day). 6. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. 7. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study. 8. Donation of blood or significant blood loss within 56 days prior to the first dosing. 9. Plasma donation within 7 days prior to the first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for Soticlestat | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat | Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | From screening up to 14 days after the last dose of soticlestat (Day 51) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 12 |
| 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. | 4 |
| 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. | 4 |
| 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. | 4 |
| 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. | 4 |
| 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. | 4 |
| 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. | 4 |
| Total | 96 |
Baseline characteristics
| Characteristic | Part A, Sequence 2: Treatment A + Treatment C + Treatment B | Total | Part B, Sequence 6: Treatment F + Treatment E + Treatment D | Part B, Sequence 5: Treatment F + Treatment D + Treatment E | Part B, Sequence 4: Treatment E + Treatment F + Treatment D | Part B, Sequence 3: Treatment E + Treatment D + Treatment F | Part B, Sequence 2: Treatment D + Treatment F + Treatment E | Part B, Sequence 1: Treatment D + Treatment E + Treatment F | Part A, Sequence 6: Treatment C + Treatment B + Treatment A | Part A, Sequence 5: Treatment C + Treatment A + Treatment B | Part A, Sequence 4: Treatment B + Treatment C + Treatment A | Part A, Sequence 3: Treatment B + Treatment A + Treatment C | Part A, Sequence 1: Treatment A + Treatment B + Treatment C |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.3 years | 40.1 years | 38.3 years | 30.3 years | 42.3 years | 49.5 years | 37.8 years | 40.0 years | 40.3 years | 40.4 years | 38.3 years | 43.1 years | 41.1 years |
| Body Mass Index (BMI) | 27.249 kilogram per meters squared (kg/m^2) | 27.286 kilogram per meters squared (kg/m^2) | 26.960 kilogram per meters squared (kg/m^2) | 26.130 kilogram per meters squared (kg/m^2) | 27.120 kilogram per meters squared (kg/m^2) | 28.030 kilogram per meters squared (kg/m^2) | 26.285 kilogram per meters squared (kg/m^2) | 26.843 kilogram per meters squared (kg/m^2) | 26.626 kilogram per meters squared (kg/m^2) | 26.840 kilogram per meters squared (kg/m^2) | 27.943 kilogram per meters squared (kg/m^2) | 27.859 kilogram per meters squared (kg/m^2) | 26.626 kilogram per meters squared (kg/m^2) |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 75 Participants | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 9 Participants | 10 Participants | 10 Participants | 7 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 21 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.4 centimeters (cm) | 170.1 centimeters (cm) | 170.0 centimeters (cm) | 172.0 centimeters (cm) | 168.0 centimeters (cm) | 172.0 centimeters (cm) | 171.8 centimeters (cm) | 172.3 centimeters (cm) | 168.5 centimeters (cm) | 171.8 centimeters (cm) | 167.5 centimeters (cm) | 174.8 centimeters (cm) | 166.8 centimeters (cm) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 10 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 85 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 12 Participants | 10 Participants | 11 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Female | 3 Participants | 23 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 5 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 9 Participants | 73 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 9 Participants | 9 Participants | 7 Participants | 11 Participants | 8 Participants |
| Weight | 78.38 kg | 79.02 kg | 78.80 kg | 77.78 kg | 77.03 kg | 82.90 kg | 77.33 kg | 79.35 kg | 79.67 kg | 78.83 kg | 78.12 kg | 85.33 kg | 74.09 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 | 0 / 72 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 4 / 72 | 5 / 72 | 0 / 72 | 0 / 24 | 2 / 24 | 1 / 24 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 | 0 / 72 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A - Treatment A | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat | 1659 ng.hr/ml | Geometric Coefficient of Variation 51 |
| Part A - Treatment B | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat | 1459 ng.hr/ml | Geometric Coefficient of Variation 58.1 |
| Part A - Treatment C | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat | 1639 ng.hr/ml | Geometric Coefficient of Variation 53.7 |
| Part B - Treatment D | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat | 1525 ng.hr/ml | Geometric Coefficient of Variation 50.6 |
| Part B - Treatment E | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat | 1354 ng.hr/ml | Geometric Coefficient of Variation 35.1 |
| Part B - Treatment F | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat | 1395 ng.hr/ml | Geometric Coefficient of Variation 49.6 |
90% CI: [92.84, 106.1]
90% CI: [81.33, 93.03]
90% CI: [78.92, 100.99]
90% CI: [81.77, 105.25]
Primary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A - Treatment A | 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 |
| Part A - Treatment B | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat | 1433 ng.hour (hr)/ml | Geometric Coefficient of Variation 54.8 |
| Part A - Treatment C | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat | 1606 ng.hour (hr)/ml | Geometric Coefficient of Variation 51.6 |
| Part B - Treatment D | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat | 1503 ng.hour (hr)/ml | Geometric Coefficient of Variation 49.1 |
| Part B - Treatment E | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat | 1317 ng.hour (hr)/ml | Geometric Coefficient of Variation 37 |
| Part B - Treatment F | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat | 1435 ng.hour (hr)/ml | Geometric Coefficient of Variation 61.9 |
90% CI: [92.17, 103.17]
90% CI: [82.14, 91.89]
90% CI: [75.92, 101.15]
90% CI: [82.73, 110.22]
Primary
Cmax: Maximum Observed Plasma Concentration for Soticlestat
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A - Treatment A | Cmax: Maximum Observed Plasma Concentration for Soticlestat | 1762 nanogram per milllilitre (ng/ml) | Geometric Coefficient of Variation 66.3 |
| Part A - Treatment B | Cmax: Maximum Observed Plasma Concentration for Soticlestat | 1428 nanogram per milllilitre (ng/ml) | Geometric Coefficient of Variation 76 |
| Part A - Treatment C | Cmax: Maximum Observed Plasma Concentration for Soticlestat | 1708 nanogram per milllilitre (ng/ml) | Geometric Coefficient of Variation 65.1 |
| Part B - Treatment D | Cmax: Maximum Observed Plasma Concentration for Soticlestat | 1509 nanogram per milllilitre (ng/ml) | Geometric Coefficient of Variation 65.7 |
| Part B - Treatment E | Cmax: Maximum Observed Plasma Concentration for Soticlestat | 565.6 nanogram per milllilitre (ng/ml) | Geometric Coefficient of Variation 49 |
| Part B - Treatment F | Cmax: Maximum Observed Plasma Concentration for Soticlestat | 1350 nanogram per milllilitre (ng/ml) | Geometric Coefficient of Variation 63.1 |
90% CI: [87.66, 107.96]
90% CI: [73.06, 89.89]
90% CI: [31.1, 45.17]
90% CI: [74.24, 107.79]
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A - Treatment A | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 6 Participants |
| Part A - Treatment B | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 12 Participants |
| Part A - Treatment C | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 7 Participants |
| Part B - Treatment D | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 0 Participants |
| Part B - Treatment E | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 2 Participants |
| Part B - Treatment F | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 1 Participants |