Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385119
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-15
Brief Title:
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers
Sponsor:
Fore Biotherapeutics
Organization:
Fore Biotherapeutics
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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-fathigh-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None