A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers. - Trial NCT06385119
Access comprehensive clinical trial information for NCT06385119 through Pure Global AI's free database. This Phase 1 trial is sponsored by Fore Biotherapeutics and is currently Recruiting. The study focuses on Healthy Volunteer. Target enrollment is 12 participants.
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Study Focus
Sponsor & Location
Fore Biotherapeutics
Timeline & Enrollment
Phase 1
Apr 24, 2024
Nov 25, 2024
Primary Outcome
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t).,AUC from time 0 extrapolated to infinity (AUC0-inf).,Maximum observed plasma concentration (Cmax).,Time to maximum observed plasma concentration (Tmax).,Terminal elimination rate constant (Kel).,Terminal phase half-life (t1/2).,Apparent oral clearance (CL/F).,Apparent volume of distribution (Vd/F).,Terminal rate constant calculated from the terminal slope of the log-linear regression of concentration with time (z).
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06385119
Non-Device Trial