A Study of TAK-279 in Healthy Chinese Adults

Sponsor
Takeda
Study ID
NCT06111547
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • TAK-279 — DRUG
    TAK-279 oral tablet.
  • Placebo — DRUG
    TAK-279 30 mg or 60 mg (2\*30mg) matching placebo tablet.

Study Details

The main aim of this study is to find out how the body of a healthy Chinese adult processes TAK-279 (pharmacokinetics). Other aims are to learn about side effects and how well TAK-279 is tolerated when given to healthy Chinese Adults. Participants will receive either TAK-279 or a placebo on Day 1 and from Day 6 to Day 19. Blood samples will be taken at different timepoints throughout the study participation. Participants will need to adhere to certain lifestyle restrictions during the study. This also includes eating and drinking restrictions. During the study, participants will need to stay at the clinic for 25 days.

Key Dates

Start date
Jun 24, 2024
Status verified
Aug 2024
Primary completion
Jul 23, 2024
Completion
Aug 4, 2024

Study Design

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

Arms

  • Experimental: Cohort 1: TAK-279 30 mg
    Participants will receive a single dose of TAK-279 30 milligram (mg) oral tablet on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.
  • Experimental: Cohort 2: TAK-279 60 mg
    Participants will receive a dose of TAK-279 60 mg (2\*30mg) oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.
  • Placebo Comparator: Cohort 1 and 2: Placebo 30 mg or 60 mg
    Participants will receive TAK-279 30 mg or 60 mg (2\*30mg) matching placebo oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition.

Primary Outcome Measure

Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of TAK-279 [ Time Frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose ]

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