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

ABSTRACT

ConditionHealthy Volunteers

InterventionDrug TAK-279;Drug TAK-279 Placebo;Drug Moxifloxacin;Drug Moxifloxacin Placebo

Primary outcome:Placebo-corrected Change From Baseline in QTc Interval (??QTc) for TAK-279

Criteria
Inclusion Criteria

1. Understand the study procedures in the informed consent form (ICF) and be willing and
able to comply with the protocol.

2. Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.

3. Female participants of childbearing potential must follow protocol specified
contraception guidance as described in protocol.

4. 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.

5. 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.

6. 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.

- No clinically significant hypokalemia, hypomagnesemia, or other electrolyte
abnormalities at the screening visit.

Exclusion Criteria

1. 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.

2. History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the Investigator or designee.

3. 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.

4. 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 within 5 years prior to first baseline
cardiodynamic measurement (Day -1), with the exception of successfully treated
nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized
carcinoma in situ of the cervix is not exclusionary.

- 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.

5. 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.

6. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs.

7. Allergy to band aids, adhesive dressing, or medical tape.

8. 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.

9. Female participant with a positive pregnancy test at the screening visit or at
check-in or who is breastfeeding and/or lactating.

10. Positive urine drug or alcohol results at the screening visit or at check-in.

11. Positive Coronavirus disease 2019 (COVID-19) result at check-in.

12. Unable to refrain from or anticipates the use of

- Any drugs, including prescription and non-prescription medications, herbal
remedies, or vitamin supplements, including any cytochrome P450 (CYP)3A4
inhibitors, beginning 14 days prior to the first baseline cardiodynamic
measurement (Day -1).

- Any drugs known to be inducers of CYP3A4 enzymes and/or P-glycoprotein (P-gp),
including St. John's Wort, for 28 days prior to the first baseline cardiodynamic
measurement (Day -1). Appropriate sources (eg, Flockhart Table™) including the
product label for moxifloxacin (Avelox [moxifloxacin hydrochloride] tablets and
intravenous injection 2020) will be consulted to confirm lack of pharmacokinetic