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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
120
TAK-279 capsule.
TAK-279 matching placebo capsule.
Moxifloxacin over-encapsulated tablet.
Moxifloxacin matching placebo capsule.
Celerion
Tempe, Arizona, United States
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279
Placebo-corrected QTc interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in Heart Rate (HR [ΔHR]) for TAK-279
HR will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in QTc (ΔQTc) Interval for TAK-279
QTc interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in PR Interval (ΔPR) for TAK-279
PR interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in QRS Interval (ΔQRS) for TAK-279
QRS interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in HR (ΔΔHR) for TAK-279
Placebo-corrected HR will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in ΔPR (ΔΔPR) for TAK-279
Placebo-corrected PR will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in QRS (ΔΔQRS) for TAK-279
Placebo-corrected QRS interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Number of Participants With Categorical Outliers for HR, PR, QRS, and QTc for TAK-279
HR, PR, QRS, and QTc will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Change From Baseline in Electrocardiogram (ECG) Morphology for TAK-279
ECG morphological analyses will be performed using the ECG waveform interpretation as defined by the central ECG laboratory's cardiologist.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for Moxifloxacin
Placebo-corrected QTc interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Maximum Observed Plasma Concentration (Cmax) of TAK-279 and Moxifloxacin
Time frame: Days 1 (TAK-279 and Moxifloxacin) and 7 (TAK-279): Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8 (Moxifloxacin): 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Time to Reach Cmax (tmax) of TAK-279 and Moxifloxacin
Time frame: Days 1 (TAK-279 and Moxifloxacin) and 7 (TAK-279): Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8 (Moxifloxacin): 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCτ) of TAK-279
Time frame: Days 1 and 7: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 hours (AUC0-24) of Moxifloxacin
Time frame: Day 1: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose; Day 8: 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Time frame: Baseline up to Day 22
Number of Participants With Markedly Abnormal Values (MAVs) in Vital signs Parameters
Vital signs assessment will include blood pressure, pulse rate, respiratory rate, and oral temperature parameters.
Time frame: Baseline up to Day 9
Number of Participants With MAVs in 12-lead ECGs Measurement
ECGs will be performed with participants in a supine position.
Time frame: Baseline up to Day 9
Number of Participants With MAVs in Clinical Laboratory Assessments
Clinical laboratory assessment will include includes hematology, chemistry, and urinalysis parameters.
Time frame: Baseline up to Day 9
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