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
Abstract
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.
Conditions: Healthy Volunteers.
Primary outcome: Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib; 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; 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; Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib; Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib; Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib; Part…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 78 participants or records.
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