Study Comparing Pharmacokinetics and Food Effects of Casdatifan Tablets in Healthy Adults Aged 18 to 55

What this Trial Is About

This trial studies the pharmacokinetics of casdatifan in healthy adults aged 18 to 55 years. It compares the absorption and concentration levels of a single 100 mg dose given as one tablet versus four 25 mg tablets under fasting conditions. The study also evaluates how food intake affects the drugs pharmacokinetics when the 100 mg dose is taken as four tablets with food. Participants receive casdatifan in three different ways four 25 mg tablets while fasting, one 100 mg tablet while fasting, and four 25 mg tablets after a meal. This crossover design allows each participant to receive all treatments in a randomized order, enabling direct comparison of absorption and drug levels. During the study, participants are monitored for up to 168 hours after each dose to measure drug concentration and how the body processes casdatifan. Researchers assess the peak concentration, time to peak, elimination rate, and total exposure to the drug. Safety is monitored by recording any adverse events for up to 43 days. The entire study is conducted with healthy volunteers, and participation lasts until all dosing and follow-up assessments are complete.

A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants