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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
78
Zasocitinib tablets specified doses on specified days.
COC tablets (containing LNG and EE) specified doses on specified days.
Metformin tablets specified doses on specified days.
Digoxin tablets specified doses on specified days.
Esomeprazole capsules specified doses on specified days.
Celerion
Tempe, Arizona, United States
Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib
Time frame: 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
Time frame: 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
Time frame: Up to 144 hours
Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib
Time frame: Up to 48 hours
Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib
Time frame: Up to 48 hours
Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib
Time frame: Up to 48 hours
Part 3: Cmax for Digoxin When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 3: AUCinf for Digoxin When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 3: AUClast for Digoxin When Administered Alone and With Zasocitinib
Time frame: Up to 144 hours
Part 4: Cmax for Zasocitinib When Administered Alone and With Esomeprazole
Time frame: Up to 120 hours
Part 4: AUCinf for Zasocitinib When Administered Alone and With Esomeprazole
Time frame: Up to 120 hours
Part 4: AUClast for Zasocitinib When Administered Alone and With Esomeprazole
Time frame: Up to 120 hours
Parts 1, 2, 3 and 4: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Time frame: 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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