Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo | Experimental | Participants will receive TAK-279 Dose 1 and matching placebo, capsules, once daily (QD) on Days 1 to 7 with moxifloxacin matching placebo, capsule, once on Days 1 and 8. |
|
| Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo | Experimental | Participants will receive TAK-279 Dose 2, capsules, QD on Days 1 to 7 with moxifloxacin matching placebo, capsule once on Days 1 and 8. |
|
| Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo | Experimental | Participants will receive moxifloxacin Dose 3, over-encapsulated tablet on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin placebo, capsule, once on Day 8. |
|
| Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin | Experimental | Participants will receive moxifloxacin matching placebo, capsule on Day 1 with TAK-279 matching placebo, QD on Days 1 to 7 and moxifloxacin Dose 3, over-encapsulated tablet, once on Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-279 | Drug | TAK-279 capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279 | Placebo-corrected QTc interval will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Heart Rate (HR [ΔHR]) for TAK-279 | HR will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Change From Baseline in QTc (ΔQTc) Interval for TAK-279 |
Not provided
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:
Able to swallow multiple capsules.
Exclusion Criteria:
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:
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.
Positive Coronavirus disease 2019 (COVID-19) result at check-in.
Unable to refrain from or anticipates the use of:
Has been on a diet incompatible with the on study diet, in the opinion of the Investigator or designee, within the 30 days prior to first baseline cardiodynamic measurement (Day -1) and throughout the study.
Has made a donation of blood or had significant blood loss within 56 days prior to first baseline cardiodynamic measurement (Day -1).
Has made a plasma donation within 7 days prior first baseline cardiodynamic measurement (Day -1).
Participated in another clinical study within 30 days prior to first baseline cardiodynamic measurement (Day -1). The 30-day window will be derived from the date of the last dosing in the previous study to Day -1 of the current study.
Herpes infections:
Positive results for non-herpetic viral diseases at the screening visit:
Positive results for tuberculosis (TB) at the screening visit or has any of the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain more information about this study, click this link | View source |
Not provided
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TAK-279 Placebo | Drug | TAK-279 matching placebo capsule. |
|
| Moxifloxacin | Drug | Moxifloxacin over-encapsulated tablet. |
|
| Moxifloxacin Placebo | Drug | Moxifloxacin matching placebo capsule. |
|
QTc interval will be measured by continuous ECG recordings.
| Baseline, Days 1, 7, and 8 |
| Change From Baseline in PR Interval (ΔPR) for TAK-279 | PR interval will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Change From Baseline in QRS Interval (ΔQRS) for TAK-279 | QRS interval will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Placebo-corrected Change From Baseline in HR (ΔΔHR) for TAK-279 | Placebo-corrected HR will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Placebo-corrected Change From Baseline in ΔPR (ΔΔPR) for TAK-279 | Placebo-corrected PR will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Placebo-corrected Change From Baseline in QRS (ΔΔQRS) for TAK-279 | Placebo-corrected QRS interval will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Number of Participants With Categorical Outliers for HR, PR, QRS, and QTc for TAK-279 | HR, PR, QRS, and QTc will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Change From Baseline in Electrocardiogram (ECG) Morphology for TAK-279 | ECG morphological analyses will be performed using the ECG waveform interpretation as defined by the central ECG laboratory's cardiologist. | Baseline, Days 1, 7, and 8 |
| Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for Moxifloxacin | Placebo-corrected QTc interval will be measured by continuous ECG recordings. | Baseline, Days 1, 7, and 8 |
| Maximum Observed Plasma Concentration (Cmax) of TAK-279 and Moxifloxacin | 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 to Reach Cmax (tmax) of TAK-279 and Moxifloxacin | 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 |
| Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCτ) of TAK-279 | Days 1 and 7: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 hours (AUC0-24) of Moxifloxacin | 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 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) | Baseline up to Day 22 |
| Number of Participants With Markedly Abnormal Values (MAVs) in Vital signs Parameters | Vital signs assessment will include blood pressure, pulse rate, respiratory rate, and oral temperature parameters. | Baseline up to Day 9 |
| Number of Participants With MAVs in 12-lead ECGs Measurement | ECGs will be performed with participants in a supine position. | Baseline up to Day 9 |
| Number of Participants With MAVs in Clinical Laboratory Assessments | Clinical laboratory assessment will include includes hematology, chemistry, and urinalysis parameters. | Baseline up to Day 9 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |