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

NCT05064449 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-10-03

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Soticlestat

Soticlestat tablets.

DRUG

Itraconazole

Itraconazole oral solution.

DRUG

Mefenamic acid

Mefenamic acid capsule.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2021-11-21
Completion
2021-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064449 on ClinicalTrials.gov