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A Study of TAK-279 in Healthy Adults on the Effect on ECG Measurements

NCT06258265 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-07-11

No results posted yet for this study

Summary

The main aim of this study is to find out how more than one dose of TAK-279 changes the heart-rate corrected QT (QTc) interval of healthy adults. A QTc interval is a measurement on an electrocardiogram (ECG) and shows the time when the heart contracts until it finishes relaxing. Other aims are to learn about the effect of several doses of TAK-279 on other ECG measurements of healthy adults, how the body of a healthy adult processes TAK-279 and moxifloxacin (pharmacokinetics), and to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults.

The participants will be given TAK-279 and moxifloxacin or a placebo for 7 days.

During the study, participants will need to stay at the clinic for 10 days.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TAK-279

TAK-279 capsule.

DRUG

TAK-279 Placebo

TAK-279 matching placebo capsule.

DRUG

Moxifloxacin

Moxifloxacin over-encapsulated tablet.

DRUG

Moxifloxacin Placebo

Moxifloxacin matching placebo capsule.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2024-06-25
Completion
2024-07-09
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 NCT06258265 on ClinicalTrials.gov