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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Takeda
Study ID
NCT06258265
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • TAK-279 — DRUG
    TAK-279 capsule.
  • TAK-279 Placebo — DRUG
    TAK-279 matching placebo capsule.
  • Moxifloxacin — DRUG
    Moxifloxacin over-encapsulated tablet.
  • Moxifloxacin Placebo — DRUG
    Moxifloxacin matching placebo capsule.

Study Details

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 Dates

Start date
Apr 29, 2024
Status verified
Jul 2024
Primary completion
Jun 25, 2024
Completion
Jul 9, 2024

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1, Therapeutic Dose Cohort: TAK-279 + TAK-279 Placebo + Moxifloxacin Placebo
    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.
  • Experimental: Cohort 2, Supratherapeutic Dose Cohort: TAK-279 + Moxifloxacin Placebo
    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.
  • Experimental: Cohort 3A, Control Cohort: Moxifloxacin + TAK-279 Placebo + Moxifloxacin Placebo
    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.
  • Experimental: Cohort 3B, Control Cohort: TAK-279 Placebo + Moxifloxacin Placebo + Moxifloxacin
    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.

Primary Outcome Measure

Placebo-corrected Change From Baseline in QTc Interval (ΔΔQTc) for TAK-279 [ Time Frame: Baseline, Days 1, 7, and 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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