NCT06258265

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

A Phase 1, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Design Thorough QT Study With Nested Crossover to Investigate the Potential of TAK-279 to Prolong the QTc Interval in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-04-29
• Primary completion: 2024-06-25
• Completion: 2024-07-09
• First posted: 2024-02-14
• Last updated: 2024-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study