NCT06385119

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

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Fore Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants. 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 following in two parts: Part A * 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. Part B * To examine the effect of a high-fat and a low-fat meal versus fasted state on the single dose PK of plixorafenib administered alone. * To examine the effect of a low-fat meal versus fasted state on the single dose PK of plixorafenib administered with cobicistat. * To determine the safety of plixorafenib administered alone or with cobicistat (low-fat meal only) in a single dose regimen.

Detailed description

Part A is an open-label, randomized, single dose, 3-treatment, 3-period, crossover design. 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. Part B is an open-label, randomized, single dose, 4-treatment, 3-period, crossover design. On Day 1 of each period (Days 1, 8, and 15 of the confinement), participants will receive a single oral dose of plixorafenib administered without cobicistat, under fasting conditions, following a standardized high-fat/high-calorie meal without cobicistat, or following a low-fat meal with or without cobicistat. 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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Plixorafenib	Oral Tablet
DRUG	Cobicistat	Oral Tablet

Timeline

• Start date: 2024-04-24
• Primary completion: 2024-12-22
• Completion: 2025-01-07
• First posted: 2024-04-25
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study