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TAK-279 for Healthy Adults

Phase 1

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Able to swallow multiple capsules

Must not have

Has a family history of sudden cardiac death

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Summary

This trial aims to study how different doses of TAK-279 affect the heart's electrical activity in healthy adults. The study will also look at how the body processes TAK-279 and another drug

Who is the study for?

This trial is for healthy adults aged 18-55 with a BMI of 18.0 to 32.0 kg/m^2, non-smokers for at least three months, and normal blood pressure and ECG readings. Women must follow specific contraception guidance.

What is being tested?

The study tests how TAK-279 affects the heart's QTc interval over multiple doses compared to moxifloxacin (an antibiotic known to affect QTc) and placebos in healthy adults during a 10-day clinic stay.

What are the potential side effects?

Potential side effects may include changes in heart rhythm as measured by ECG, which could indicate abnormal electrical activity of the heart; other side effects will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy adult between 18 and 55 years old.

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I can swallow several pills at once.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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A family member of mine has died suddenly from a heart condition.

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I am mentally capable and emotionally stable to participate in a study.

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I have not had a fever or active infection in the last 7 days.

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I have had serious infections like Pneumocystis pneumonia.

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I have a history of heart issues like irregular heartbeat or heart attack.

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I have heart disease, high blood pressure, or other heart issues.

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I am not pregnant, breastfeeding, or lactating.

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I haven't been hospitalized or treated for a serious infection in the last 8 weeks.

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I have a history of chronic or recurrent infections.

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I have a condition that weakens my immune system.

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I have a history of heart problems, including arrhythmias or fainting episodes.

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I can avoid taking any drugs or supplements, including CYP3A4 inhibitors, 14 days before my first heart test.

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I currently have an active herpes infection.

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I have had severe herpes infections, including widespread or repeated outbreaks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve During a Dosing Interval (tau) at Steady State (AUCτ) of TAK-279

Area Under the Plasma Concentration-Time Curve From Time Zero to 24 hours (AUC0-24) of Moxifloxacin

Change From Baseline in Electrocardiogram (ECG) Morphology for TAK-279

+15 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + MoxifloxacinExperimental Treatment3 Interventions

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.

Group II: Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin PlaceboExperimental Treatment3 Interventions

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.

Group III: Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin PlaceboExperimental Treatment2 Interventions

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.

Group IV: Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin PlaceboExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TAK-279

2023

Completed Phase 1

~220

Moxifloxacin

2013

Completed Phase 4

~3290

Moxifloxacin Placebo

2012

Completed Phase 3

~1400

0 / 16Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor

1,213 Previous Clinical Trials

4,187,033 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,230 Previous Clinical Trials

500,970 Total Patients Enrolled

~80 spots leftby Sep 2025

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