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
Abstract
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.
Primary outcome: Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279.
Enrollment: 120 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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