A Study of Soticlestat Tablets in Healthy Adults

Takeda

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Soticlestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT05284760

TAK-935-1014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 12 patient groups

Part A, Sequence 1: Treatment A + Treatment B + Treatment C

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part A, Sequence 2: Treatment A + Treatment C + Treatment B

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part A, Sequence 3: Treatment B + Treatment A + Treatment C

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part A, Sequence 4: Treatment B + Treatment C + Treatment A

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part A, Sequence 5: Treatment C + Treatment A + Treatment B

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part A, Sequence 6: Treatment C + Treatment B + Treatment A

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part B, Sequence 1: Treatment D + Treatment E + Treatment F

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part B, Sequence 2: Treatment D + Treatment F + Treatment E

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part B, Sequence 3: Treatment E + Treatment D + Treatment F

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part B, Sequence 4: Treatment E + Treatment F + Treatment D

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part B, Sequence 5: Treatment F + Treatment D + Treatment E

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat

Part B, Sequence 3: Treatment F + Treatment E + Treatment D

Experimental group

Description:

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 will be maintained between each Treatment Period.

Treatment:

Drug: Soticlestat

Drug: Soticlestat

Drug: Soticlestat