A Study of TAK-279 in Healthy Adults on the Effect on ECG Measurements (NCT06258265) | Clinical Trial Compass
CompletedPhase 1
A Study of TAK-279 in Healthy Adults on the Effect on ECG Measurements
United States120 participantsStarted 2024-04-29
Plain-language 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.
Who can participate
Age range18 Years β 55 Years
SexALL
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Inclusion criteria
β. Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
β. Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.
β. Female participants of childbearing potential and non-sterilized male participants must follow protocol specified contraception guidance as described in protocol.
β. Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first baseline cardiodynamic measurement (Day -1) based on participant self-reporting.
β. BMI greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilograms per meter square (kg/m\^2) at the screening visit.
β. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the Investigator or designee, including the following:
β. Able to swallow multiple capsules.
Exclusion criteria
What they're measuring
1
Placebo-corrected Change From Baseline in QTc Interval (ΞΞQTc) for TAK-279
. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
β. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
β. History of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
β. Has a history of any of the following:
β. Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to first baseline cardiodynamic measurement (Day -1), as determined by the Investigator or designee.
β. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.
β. Allergy to band aids, adhesive dressing, or medical tape.
β. History or presence of any of the following, deemed clinically relevant by the Investigator or designee at the screening visit or at check-in: