NCT06793943

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

A Phase 1, Open-Label, 4-Part Trial to Assess the Drug-Drug Interaction Between Zasocitinib and Combined Oral Contraceptives, a MATE Substrate, a P-gp Substrate, and a Proton-Pump Inhibitor in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The drug being tested in this study is called zasocitinib. Zasocitinib is being tested to assess the effect of zasocitinib on the pharmacokinetics of Combined Oral Contraceptive (COC \[containing LNG and EE\] in Part 1), multidrug and toxic compound extrusion (MATE) substrate (metformin in Part 2), and a P-glycoprotein (P-gp) substrate (digoxin in Part 3). Additionally, the effect of proton-pump inhibitor (PPI) (esomeprazole in Part 4) on the pharmacokinetics of zasocitinib is being evaluated in healthy participants. The study will enroll approximately 78 participants. Participants will be enrolled in one of the four parts to evaluate the following treatments: * Part 1: COC (LNG and EE) + Zasocitinib * Part 2: Metformin + Zasocitinib * Part 3: Digoxin + Zasocitinib * Part 4: Zasocitinib + Esomeprazole The overall time (including screening and follow-up periods) to participate is approximately 68 days for Part 1, 54 days for Part 2, 62 days for Part 3 and 56 days for Part 4. All participants will be followed up for up to 14 days after the last dose of Period 2 in each Part.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Zasocitinib	Zasocitinib tablets specified doses on specified days.
DRUG	COC	COC tablets (containing LNG and EE) specified doses on specified days.
DRUG	Metformin	Metformin tablets specified doses on specified days.
DRUG	Digoxin	Digoxin tablets specified doses on specified days.
DRUG	Esomeprazole	Esomeprazole capsules specified doses on specified days.

Timeline

• Start date: 2025-01-23
• Primary completion: 2025-03-11
• Completion: 2025-03-30
• First posted: 2025-01-27
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study