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NCT06385119

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

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.
Fore Biotherapeutics·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
Plixorafenib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Fore Biotherapeutics
Location
Austin, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Apr 24, 2024
End date
Nov 25, 2024
Enrollment
12 participants
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
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06385119
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.