A Study of TAK-279 in Healthy Adults on the Effect on ECG Measurements

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID: NCT06258265
Run by: Takeda
People needed: 120
Starts: 2024-04-29
Expected to finish: 2024-07-09
Last updated by the study team: 2024-07-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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:
Supine blood pressure is >=90/40 millimeter of mercury (mmHg) and <=140/90 mmHg at the screening visit.
Supine pulse rate is >=40 beats per minute (bpm) and <=99 bpm at the screening visit.
QTc using Fridericia's formula (QTcF) interval is <=450 milliseconds (msec) (males) and <=460 msec (female) at the screening visit.
QRS interval <=110 msec at the screening visit (if >110 msec, result will be confirmed by a manual over read).
PR interval <=220 msec at the screening visit.
eGFR >=80 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2) at the screening visit.
Liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin <=upper limit of normal (ULN) at the screening visit and at check-in.
Creatine phosphokinase (CPK) <=ULN at the screening visit and at check-in.
Amylase and lipase <=ULN at the screening visit and at check-in.
No clinically significant hypokalemia, hypomagnesemia, or other electrolyte abnormalities at the screening visit.
Able to swallow multiple capsules.

You may not qualify if…

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:
Active infection or febrile illness within 7 days prior to first baseline cardiodynamic measurement (Day -1), as assessed by the Investigator or designee.
Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to first baseline cardiodynamic measurement (Day -1).
Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis).
An infected joint prosthesis unless that prosthesis has been removed or replaced greater than 60 days prior to first baseline cardiodynamic measurement (Day -1).
Opportunistic infections (eg, Pneumocystis jirovecii pneumonia, histoplasmosis, coccidiomycosis).
Cancer or lymphoproliferative disease, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy.
Liver, kidney, heart, or other solid organ transplant.
Myasthenia gravis.
Peripheral neuropathy.
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:
Cardiac disease; arrhythmias, presyncope, or syncopal episodes; heart failure, heart disease or risk factors for torsades de pointes (including long QT syndrome or family history of long QT syndrome).
Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, history of cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.
Ischemic heart disease, poorly controlled hypertension, or other cardiovascular disorder
T wave flattening or other abnormalities which in the opinion of the Investigator or designee may interfere with the analysis of QT intervals.
A family history of sudden cardiac death.
Female participant with a positive pregnancy test at the screening visit or at check-in or who is breastfeeding and/or lactating.
Positive urine drug or alcohol results at the screening visit or at check-in.

Where it is running

Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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