A Study of Interaction of Zasocitinib (TAK-279) With Other Medicines in Healthy Adults
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06793943
- Lead Sponsor
- Takeda
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: COC (LNG and EE) + Zasocitinib Zasocitinib - Part 1: COC (LNG and EE) + Zasocitinib COC - Part 2: Metformin + Zasocitinib Zasocitinib - Part 2: Metformin + Zasocitinib Metformin - Part 3: Digoxin + Zasocitinib Zasocitinib - Part 3: Digoxin + Zasocitinib Digoxin - Part 4: Zasocitinib + Esomeprazole Zasocitinib - Part 4: Zasocitinib + Esomeprazole Esomeprazole - Part 1: COC (LNG and EE) + Zasocitinib COC - Part 2: Metformin + Zasocitinib Metformin - Part 3: Digoxin + Zasocitinib Digoxin - Part 4: Zasocitinib + Esomeprazole Esomeprazole - Part 1: COC (LNG and EE) + Zasocitinib Zasocitinib - Part 2: Metformin + Zasocitinib Zasocitinib - Part 3: Digoxin + Zasocitinib Zasocitinib - Part 4: Zasocitinib + Esomeprazole Zasocitinib -
- Primary Outcome Measures
Name Time Method Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib Up to 144 hours Part 1: AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for LNG and EE When Administered Alone and With Zasocitinib Up to 144 hours Part 1: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for LNG and EE When Administered Alone and With Zasocitinib Up to 144 hours Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib Up to 48 hours Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib Up to 48 hours Part 4: Cmax for Zasocitinib When Administered Alone and With Esomeprazole Up to 120 hours Part 4: AUClast for Zasocitinib When Administered Alone and With Esomeprazole Up to 120 hours Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib Up to 48 hours Part 3: Cmax for Digoxin When Administered Alone and With Zasocitinib Up to 144 hours Part 3: AUCinf for Digoxin When Administered Alone and With Zasocitinib Up to 144 hours Part 3: AUClast for Digoxin When Administered Alone and With Zasocitinib Up to 144 hours Part 4: AUCinf for Zasocitinib When Administered Alone and With Esomeprazole Up to 120 hours
- Secondary Outcome Measures
Name Time Method Parts 1, 2, 3 and 4: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs) Part 1: Up to 33 days; Part 2: Up to 23 days; Part 3: Up to 27 days; Part 4: Up to 23 days
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Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States