Healthy Volunteer Clinical Trial
Official title:
A Phase 1, Open-Label, 2-Part, Single Dose, Crossover Study to Examine the Effect of Food and Cobicistat Administration on the Pharmacokinetics and Safety of Plixorafenib in Healthy Participants.
The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine: - The effect of food on the single dose PK of plixorafenib administered with cobicistat. - The effect of cobicistat administration on the single dose PK of plixorafenib. - The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants.
This is an open-label, randomized, 3-period crossover, study. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered either with or without cobicistat, under fasting conditions or following a standardized high-fat/high-calorie meal. PK blood and urine samples will be collected at pre-dose and at several post-dose time points. There will be a washout period between doses. Participants will be confined for total of 19 days. ;
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