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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Understand the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.
. Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.
. Female participants of childbearing potential and non-sterilized male participants must follow protocol specified contraception guidance as described in protocol.
. 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.
. 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.
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) 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.
. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
. 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.
. Has a history of any of the following:
. 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.
. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.
. Allergy to band aids, adhesive dressing, or medical tape.
. History or presence of any of the following, deemed clinically relevant by the Investigator or designee at the screening visit or at check-in: