A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Takeda
Study ID
NCT06793943
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Zasocitinib — DRUG
    Zasocitinib tablets specified doses on specified days.
  • COC — DRUG
    COC tablets (containing LNG and EE) specified doses on specified days.
  • Metformin — DRUG
    Metformin tablets specified doses on specified days.
  • Digoxin — DRUG
    Digoxin tablets specified doses on specified days.
  • Esomeprazole — DRUG
    Esomeprazole capsules specified doses on specified days.

Study Details

The main aim of this study is to find out how zasocitinib (TAK-279) interacts with other medicines taken by mouth (orally). This will be examined by how the body processes medicines, which is called pharmacokinetics or PK. In this study, other medicines that will be administered together with zasocitinib include a contraceptive (levonorgestrel (LNG) and ethinyl estradiol \[EE\]), a medicine for diabetes (metformin), a medicine used for heart problems (digoxin), and a medicine that blocks the production of stomach acid (esomeprazole). Another aim is to learn about the side effects of zasocitinib and how well it is tolerated when taken alone and together with these other medicines. During the study, participants will need to stay at the clinic for up to 27 days.

Key Dates

Start date
Jan 23, 2025
Status verified
Apr 2025
Primary completion
Mar 11, 2025
Completion
Mar 30, 2025

Study Design

Enrollment
78 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Part 1: COC (LNG and EE) + Zasocitinib
  • Experimental: Part 2: Metformin + Zasocitinib
  • Experimental: Part 3: Digoxin + Zasocitinib
  • Experimental: Part 4: Zasocitinib + Esomeprazole

Primary Outcome Measure

Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib [ Time Frame: Up to 144 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

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By research site
Celerion· Tempe, AZ

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