NCT05064449

A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults

A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole and Mefenamic Acid on the Single-Dose Pharmacokinetic Profile of Soticlestat in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body. The study will have 2 parts. Participants can only participate in one study part. Part 1: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving itraconazole and will stay in the clinic for 11 more days, receiving soticlestat in combination with itraconazole on one of those days. Participants will be contacted about 8 days after leaving the clinic for follow-up. Part 2: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving mefenamic acid and will stay in the clinic for 7 more days, receiving soticlestat in combination with mefenamic acid on one of those days.. Participants will be contacted about 9 days after leaving the clinic for follow-up.

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 either itraconazole or mefenamic acid in healthy participants. The study will be conducted in 2 parts: Part 1 (drug-drug interaction \[DDI\] with itraconazole), Part 2 (DDI with mefenamic acid). The study will enroll approximately 28 participants. Participants will be enrolled into two parts (Part 1 and Part 2) to receive soticlestat along with adjunctive therapy itraconazole and mefenamic acid as: * Part 1: Soticlestat 300 mg + Itraconazole 200 mg * Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg (first dose only) and 250 mg (subsequent doses) Both Parts 1 and 2 will have two period (Periods 1 and 2). In Period 1, participants will receive only soticlestat (study drug) and in Period 2, participants will receive study drug along with either itraconazole or mefenamic acid depending upon in which part they are in. The data will be collected and stored in electronic case report form (eCRF). This single-center trial will be conducted in the United States. The overall duration of the study is approximately 52 days for participants in Part 1 (includes screening and follow-up), but 48 days for participants in Part 2 (including screening and follow-up). There will be follow up for all participants approximately 15 days after the last dose of soticlestat in each study part.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Soticlestat	Soticlestat tablets.
DRUG	Itraconazole	Itraconazole oral solution.
DRUG	Mefenamic acid	Mefenamic acid capsule.

Timeline

• Start date: 2021-10-14
• Primary completion: 2021-11-21
• Completion: 2021-11-30
• First posted: 2021-10-01
• Last updated: 2023-10-03
• Results posted: 2023-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study