A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.
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.
Timeline
- Start
- 2024-04-24
- Primary completion
- 2024-12-22
- Completion
- 2025-01-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cobicistat | Small molecule | 150 mg | Oral |
| Subject | Plixorafenib | Small molecule | 900 mg | Oral |
Indications
No indication recorded.