A Study of Soticlestat and Rifampin in Healthy Adults

NCT ID: NCT05098041

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-22
• Study Completion Date: 2022-03-03

Brief Summary

The main aim of this study is to check how rifampin affects the way soticlestat is processed by the body.

Participants will be required to stay at the study clinic for 18 consecutive days. On the first full day and 15th day, participants will take a single dose of soticlestat. Rifampin will be taken each day starting on the 5th day for 13 consecutive days.

Clinic staff will follow up with each participant about 15 days after the last soticlestat dose to check for any side effects.

Detailed Description

The drug being tested in this study is called soticlestat (TAK-935). The study will evaluate the safety and tolerability of soticlestat when co-administered with rifampin in healthy participants.

The study will enroll 14 participants. The participants will be assigned to treatment group to receive following therapies:

• Soticlestat 300 milligram (mg) + Rifampin 600 mg

The study will have two periods: Period 1 and Period 2. In Period 1, participants will receive soticlestat in fasted condition while in Period 2 participants will receive soticlestat along with rifampin. The data will be collected and stored in electronic case report form (eCRF).

This single-center trial will be conducted in the United Kingdom. The overall study duration of the study will be approximately 58 days including 28 days screening and follow up duration. There will be a follow up contact required for all participants approximately 15 days after the last dose of soticlestat.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Soticlestat 300 mg + Rifampin 600 mg

Soticlestat 3\*100 mg tablets, orally, administered once on Day 1 in fasted state in Period 1, followed by a washout period of 4 days, further followed by Rifampin 600 mg, administered as 2\*300mg capsules, orally, once daily for 13 consecutive days, from Day 1 to Day 13 in fasted state in Period 2. Soticlestat 3\*100 mg tablets, will be administered orally along with rifampin 600 mg (2\*300mg) capsules, orally in the morning of Day 11 in Period 2.

Group Type: EXPERIMENTAL

Soticlestat

Intervention Type: DRUG

Soticlestat tablets.

Rifampin

Intervention Type: DRUG

Rifampin capsules.

Interventions

Soticlestat

Soticlestat tablets.

Intervention Type: DRUG

Rifampin

Rifampin capsules.

Intervention Type: DRUG

Other Intervention Names

TAK-935

Eligibility Criteria

Inclusion Criteria

1. Healthy, adult, male or female of non-childbearing potential, 18-55 years of age, inclusive, at screening.

2. Has 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.

3. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing.

4. Able to swallow multiple tablets/capsules.

Exclusion Criteria

1. Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.

2. Any positive responses on the C-SSRS that in the clinical judgment of the Investigator has a risk of suicide or has made a suicide attempt in the previous 12 months prior to the first dosing.

3. 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 first dosing.
• Any drugs known to be significant inducers of cytochrome (CYP)3A, CYP2C19, UGT1A9 or UGT2B4 enzymes, and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing.

Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of pharmacokinetic (PK)/pharmacodynamics interaction with study drug.

4. History of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer 354 milliliter [mL]/12 ounce [oz], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).

5. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.

6. 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.

7. Donation of blood or significant blood loss within 56 days prior to the first dosing.

8. Plasma donation within 7 days prior to the first dosing.

9. Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-days window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Celerion

Belfast, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/6181d800eb0e19002afd69ec

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

Other Identifiers

TAK-935-1009

Identifier Type: -

Identifier Source: org_study_id