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A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval

NCT05309902 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-11-14

No results posted yet for this study

Summary

The main aim is to see if soticlestat has any effect in the heart rate.

Participants will receive 4 doses of soticlestat in tablets and will complete some assessment which include to record activity of the heart and collection of blood samples.

Then, the clinic will contact the participants 14 days after their final dose of soticlestat to check if they have any health problems.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Soticlestat

Soticlestat tablet.

DRUG

Placebo

Soticlestat placebo-matching tablet.

DRUG

Moxifloxacin

Moxifloxacin over-encapsulated tablet.

DRUG

Placebo

Moxifloxacin placebo-matching capsule.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2022-12-06
Completion
2022-12-06
FDA Drug
Yes

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Entities

Drugs
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 NCT05309902 on ClinicalTrials.gov