A Study of Soticlestat Tablets in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of Soticlestat Oral Tablet Formulations and the Effect of Food and Tablet Crushing on the Pharmacokinetics of Soticlestat in Healthy Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05284760
• Other study ID #: TAK-935-1014
• Status: Completed
• Phase: Phase 1
• Start date: March 11, 2022
• Est. completion date: June 2, 2022

Study information

• Verified date: February 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Soticlestat
Soticlestat T4 tablets.
• Soticlestat
Soticlestat T3 mini-tablets.
• Soticlestat
Soticlestat commercial tablets.

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for Soticlestat		Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Primary	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
Primary	AUC8: 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	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.	From screening up to 14 days after the last dose of soticlestat (Day 51)

External Links

•   To obtain more information on the study, click here/on this link