Celerion
Tempe, Arizona, 85283, United States
NCT Number: NCT06258265
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAK-279 capsule.
TAK-279 matching placebo capsule.
Moxifloxacin over-encapsulated tablet.
Moxifloxacin matching placebo capsule.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected QTc interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
HR will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
QTc interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
PR interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
QRS interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected HR will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected PR will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
Placebo-corrected QRS interval will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
HR, PR, QRS, and QTc will be measured by continuous ECG recordings.
Time frame: Baseline, Days 1, 7, and 8
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 QTc interval will be measured by continuous ECG recordings.
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 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 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
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
Time frame: Baseline up to Day 22
Time frame: Baseline up to Day 9
Vital signs assessment will include blood pressure, pulse rate, respiratory rate, and oral temperature parameters.
Time frame: Baseline up to Day 9
ECGs will be performed with participants in a supine position.
Time frame: Baseline up to Day 9
Clinical laboratory assessment will include includes hematology, chemistry, and urinalysis parameters.
Takeda
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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