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A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers.

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.

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06385119
Study type Interventional
Source Fore Biotherapeutics
Contact Michael Paz
Phone 267-641-7575
Email trials@fore.bio
Status Recruiting
Phase Phase 1
Start date April 24, 2024
Completion date November 25, 2024
View Details
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