This will be a Phase 1, 2 period, fixed sequence, multiple-dose, open-label study of the effect of ritlecitinib on caffeine PK in healthy participants. Approximately 12 healthy male and/or female participants will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
100milligram (mg) tablet taken orally in period 1 and period 2
200 milligrams (mg) taken orally once a day(QD) for 8 days
New Haven Clinical Research Unit
New Haven, Connecticut, United States
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) of caffeine
Time frame: Day1 and Day8: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24. Day 8: Hour 36 and 48
Incidence of treatment-emergent adverse events
Time frame: Baseline through Day 28
Incidence of clinically significant abnormalities in vital signs
Time frame: Baseline through Day 11
Incidence of clinically significant abnormalities in clinical laboratory values
Time frame: Baseline through Day 11
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.